Category Archives: International Stem Cell Corp. ISCO

International Stem Cell Corp. (ISCO): A Double Threat with Cutting-Edge, Ethically Derived Stem Cell Therapies & Commercial-Scale Biobanking

August 27, 2015

On the cusp of milestone TGA (Therapeutic Goods Administration) authorization in Australia to start clinical trials in its breakthrough Parkinson’s disease (PD) treatment using human parthenogenetic neural stem cells (hpNSCs), International Stem Cell Corp. (OTCQB: ISCO) was proud to show markets recently that the company has achieved a point of maturity where it is also driving home steadily increasing revenues. The release of the company’s Q2 2015 data also showed record net income for the quarter, with outlays decreasing due to having successfully wrapped on a number of important preclinical studies, even as revenues increased 14 percent year over year, and profit margins held steady at around 72 percent.

The company’s increasingly lucrative biomedical business and consistently profitable regenerative skin care offerings, administrated respectively via ISCO’s wholly-owned Lifeline Cell Technology and Lifeline Skin Care subsidiaries, continue to materially backstop the ongoing development of an exciting therapeutic pipeline based on proprietary human parthenogenetic stem cell (hpSC) technology which is efficient, perfect for commercial scale volumes, and also completely ethical. ISCO’s parthenogenesis technology employs a unique chemical stimulation technique for triggering unfertilized donor human eggs to create pluripotent cells that can then be differentiated through proprietary activation into numerous types of cells. From the aforementioned hpNSCs, which are increasingly seen via the company’s trial work as a paradigm shift approach when it comes to treating neurological system conditions like PD and even ischemic stroke. To liver and eye cells that can be used to effectively treat degenerative diseases affecting those tissue systems, such as metabolic liver disease and macular degeneration.

Just looking at the company’s application of hpNSCs in PD, we see a fundamentally new approach to therapy using transplanted stem cells, which could actually solve the underlying problems that give rise to such conditions, rather than just attempting to ameliorate the condition as with many other therapies, including the current standards of care. In PD, where injected hpNSCs actively differentiate into both dopaminergic neurons, as well as express brain-protecting neurotrophic factors, and thus directly address the two primary causes of debilitation, this approach shows its monumental superiority to other approaches by simultaneously replacing dead neurons and protecting any survivors. This kind of therapeutic solution constitutes an end-run on PD, and potentially many other diseases/disorders via a completely ethical, high-volume stem cell production technology, and it could make ISCO into one of the now $27 billion plus global stem cell market’s heaviest hitters.

Recent projections by Transparency Market Research indicate that the global stem cell market is just getting warmed up too. With around 24 percent CAGR seen occurring through 2018 and valuations the following year of as much as $119 billion or more, this highly fragmented market is primed for explosive growth. Something which is especially true for real innovators like ISCO, given that pluripotent stem cells are also seen as rapidly eclipsing the core adult stem cell type that currently has around 80 percent of the market share.

Perhaps even more importantly, the company’s UniStemCell bank, which is effectively the life science industry’s first commercial-scale aggregation of histocompatible, non-embryonic human stem cells, is ideally positioned to benefit from the continued upswing in the sector. Providing a growing logistical footprint of high-quality material for research purposes, as well as commercial applications. Moreover, ISCO has established a solid presence already here in the U.S., which is the epicenter of global activity for the stem cell industry due to federal government support for the sector. As the biobanking market expands further into Europe and other global markets, the company will benefit from first-mover advantages.

To take a closer look, visit www.internationalstemcell.com

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International Stem Cell Corp. (ISCOD) Leading the Way in Emerging Field of Regenerative Medicine with Parthenogenetic Stem Cell Technology

August 20, 2015

International Stem Cell Corporation is a biotechnology company utilizing a proprietary new stem cell technology known as parthenogenesis to significantly advance the field of regenerative medicine. The company’s innovative technology uses unfertilized human eggs to create human pluripotent stem cells (hpSC) that can be immune-matched to millions of people around the globe. These stem cells are unique in that they provide the best characteristics of each of the remaining classes of cells without the need for the creation or destruction of a viable embryo.

The company’s business strategy features three unique channels for revenue generation within the biotechnology industry – including its core stem cell technology and related intellectual property, which encompasses 220 patents, applications and licenses associated with the development and manufacture of pluripotent cells, as well as its therapeutic research projects and promising development pipeline.

Lifeline Skin Care, the company’s wholly-owned subsidiary, is an industry leader in effective anti-aging stem cell skin care. Since being established in 2010, Lifeline has served as a growing source of vital financial support to fund ISCO’s ongoing medical research. In 2014, Lifeline accounted for more than $7 million in total revenue, which was primarily allocated to the advancement of the company’s promising development pipeline.

UniStemCell is the life science industry’s first collection of non-embryonic histocompatible human stem cells available for research and commercial use. This cell bank gives the company a nearly inexhaustible source of stem cells that can be used to generate revenue in the medium term. As the company’s hpSC lines gain additional validation, they are expected to provide the company with royalty from sales of each successful hpSC-derived cellular therapeutic in the future.

In addition to the sale of its stem cells, ISCO is making noteworthy progress toward the continued advancement of its development pipeline. The company is currently engaged in pre-clinical development addressing a host of unmet medical needs. Parkinson’s disease, which affects an estimated one million people in the United States, represents ISCO’s leading development indication, with phase I/II clinical trials expected to begin in the coming months. Following the completion of initial studies, the company will seek out a suitable partner to assist with late-stage clinical development.

With its groundbreaking stem cell technology, ISCO is developing a significant presence within the expansive field of regenerative medicine. By successfully mitigating many of the limiting factors commonly associated with stem cell research – including auto-immune rejection and ethical debate surrounding the use of embryonic cells – the company is leveraging the marketability of its technology as a catalyst for continued growth.

Research indicates that the global regenerative medicine market is expected to grow at a CAGR of 12.2 percent through 2017, climbing to an estimated $24.7 billion by the end of the period. ISCO will look to capitalize on this market performance under the guidance of an executive management team with decades of experience in a collection of related scientific sectors.

For more information, visit www.internationalstemcell.com

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International Stem Cell Corp. (ISCO) Posts Record Financial Results in the Second Quarter of 2015

August 18, 2015

International Stem Cell Corp. is expanding its presence in the emerging field of regenerative medicine through the development of its novel stem cell-based therapies and biomedical products. In recent months, this progress has translated into record-setting financial results, as the company has continued to position itself as a major player in the biotechnology industry.

“Stable increase in revenues from our biomedical businesses, ability to generate net income as a parent company and progress in demonstrating the safety and efficacy of our stem cells for the treatment of Parkinson’s disease and stroke position us as a leader in [the] regenerative medicine field,” Dr. Andrey Semechkin, chief executive officer and co-chairman of ISCO, stated in a news release.

In the second quarter of 2015, ISCO realized a 14 percent year-over-year increase in total revenue, recording $1.82 million. This growth was primarily fueled by the performance of the company’s subsidiary, Lifeline Skin Care, which recorded an 18 percent year-over-year increase in revenue for the period. In addition to expanding upon the customer base of its existing product lines, ISCO also completed the development and testing of two new products to be sold under the trusted Lifeline Skin Care brand moving forward. Lifeline Cell Technology, ISCO’s human cell manufacturing subsidiary, posted similar financial growth for the quarter, recording an 11 percent year-over-year increase in sales.

The company’s strong financial performance through its subsidiaries helped fund its considerable progress toward the development of its proprietary human parthenogenetic neural stem cells (hpNSCs). In preclinical testing, ISCO demonstrated the capability of its cells to significantly reduce neurological dysfunction following a stroke in animal models. Following the publication of two proof of concept studies that demonstrate the safety and efficacy of the company’s stem cell treatment techniques in both non-human primate and rodent animal models, ISCO expects to begin its Parkinson’s disease trials in the Australian market before the end of this year.

“We look forward to receiving Australian TGA authorization to start clinical trials,” continued Semechkin. “We expect to dose the first Parkinson’s disease patients in this trial in Q4 2015.”

For prospective shareholders, ISCO’s ability to generate revenue and maintain a strong cash position during clinical development programs is a promising indication of the company’s long-term viability. Look for ISCO to continue leaning on the established market presence of its subsidiaries in order to fund the ongoing clinical development of its promising Parkinson’s disease treatment program while simultaneously promoting sustainable returns.

For more information, visit www.internationalstemcell.com

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International Stem Cell Corp. (ISCOD) Preparing to Initiate Clinical Development for the Treatment of Parkinson’s Disease in Australia

August 11, 2015

International Stem Cell Corp. recently took a significant step toward expanding its clinical pipeline when it submitted preclinical data to the Australian Therapeutic Goods Administration (TGA) regarding its impending phase I/IIa clinical trial for the treatment of Parkinson’s disease. According to the submitted data, the company’s nine month study of 300 rodents resulted in no tumors being observed in any of the animal subjects, demonstrating the safety and efficacy of its human neural stem cells (hpNSCs), which were derived using ISCO’s proprietary parthenogenetic stem cell platform. The company predicts that this will be the final submittal required prior to the initiation of clinical studies.

“We expect that this study report will address the remaining safety elements necessary for regulatory approval,” Dr. Ruslan Semechkin, chief science officer of ISCO, stated in a news release. “Having provided this final submission we now look forward to receiving TGA authorization to begin our phase I/IIa clinical trial in Australia.”

If approved to begin clinical trials, ISCO will be in a strong strategic position to enter the Australian Parkinson’s disease treatment market in the future, which could provide the company with a substantial opportunity to achieve sustainable international growth. According to a report by Parkinson’s Queensland, approximately one in 350 Australians live with Parkinson’s disease, making it the country’s second most common neurodegenerative disorder. In 2011, the debilitating disease accounted for an estimated $480 million in national health system costs, further demonstrating the market potential of ISCO’s groundbreaking treatment option following regulatory approval.

ISCO’s proprietary approach to stem cell research, parthenogenesis, directly addresses many of the limiting factors typically associated with regenerative medicine. In particular, the company’s parthenogenetic homozygous stem cell line can be a source of therapeutic cells for hundreds of millions of individuals with minimal risk of immune rejection following transplantation. Additionally, since its cells are derived from unfertilized eggs, ISCO avoids many of the ethical issues associated with embryonic stem cells without sacrificing their transformative pluripotent qualities.

For prospective shareholders, the company’s strong progress toward expanding its market share in the global regenerative medicine industry could foreshadow an opportunity for sustainable returns in the months to come. Look for ISCO to build on this progress moving forward as it eagerly awaits TGA authorization to begin its pivotal clinical development program in the Australian market.

For more information, visit www.internationalstemcell.com

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International Stem Cell Corp. (ISCOD) Reports Completion of New Compound’s Clinical Testing

August 7, 2015

Yesterday, International Stem Cell Corp., a California-based biotechnology company developing novel stem cell based therapies and biomedical products, announced the completion of a recently discovered compound’s clinical testing. This compound is expected to be utilized in skin care products marketed by the company’s wholly-owned subsidiary Lifeline Skin Care, Inc.

Topical treatment with the compound showed significant (p<0.01) improvement in skin elasticity and decrease in skin roughness in all subjects 4 and 8 weeks after the start of the study. In addition, the compound-treated group outperformed not only the baseline, but also the Retinol treated group. There were no adverse events reported in the compound-treated group, such as skin irritation, which has been reported as a common side effect of Retinol treatment.

Prior to the clinical study, the compound was tested on different in vitro models: normal human keratinocytes, fibroblasts and 3D model of human skin. In all these models, the recently discovered compound induced up to twice the production of elastin and collagen compared to Retinoic Acid (the active form of Retinol) with none of its toxic characteristics.

The launch of the compound-based products is expected this year. Currently Lifeline markets its stem cell-based skin care in the US and Asia via professional and on-line retail channels (www.lifelineskincare.com). The company believes that these new compound-based products will not only allow it to increase sales and profit margins in its existing markets, but also will allow it to enter the European “high-tech” skin care market.

For more information on International Stem Cell Corp., visit www.internationalstemcell.com

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International Stem Cell Corp. (ISCOD) Prepares To Up-List, Tightens Share Structure Ahead of Landmark Parkinson’s Clinical Trial

August 5, 2015

With the success of its nine-month GLP safety (tumorigenicity) and biodistribution animal model study in Parkinson’s Disease (PD) showing a completely clean record, as zero tumor growth was observed across a batch of 300 rodents injected with the company’s ethically and proprietarily-derived human neural stem cells (hpNSCs), International Stem Cell Corp. has subsequently taken a major step to increase the company’s market presence and up-list to a major exchange, announcing a reverse stock split in order to tighten the overall share structure. Since the July 29 split announcement, the company’s ticker has been ISCOD, and it will remain so until the typical period of approximately 20 days has elapsed.

The recently completed nine month GLP safety study, which capitalizes on a long track record of successfully demonstrated results stretching back to such examples as the 2013 work with Duke University’s Clinical Research Institute, was the last step needed for International Stem Cell to secure the previously announced landmark phase 1/2a clinical trial in PD with the Australian Therapeutic Goods Administration via the company’s recently-formed Australian subsidiary, Cyto Therapeutics Pty Ltd. The company has quite a preclinical dataset to back up its novel approach to treating PD with injected hpNSCs, which are self-renewing multipotent precursor cells to the main types of cells that make up the CNS (central nervous system), created using the company’s proprietary parthenogenetic technology, which chemically differentiates unfertilized human eggs (oocytes) into pluripotent stem cells (capable of giving rise to many different cell types).

This extensive preclinical dataset the company has thus far amassed, showing zero evidence of tumor formation at even high dosages (including proof-of-principle PD cohort studies and additional studies focused on safety), combined with direct evidence that injected hpNSCs exhibit a neuroprotectant capacity, as well as an ability to actively recover neurons and address the core motor function symptomatology of PD characterized by dopamine deficiency, is an extremely positive forward indicator to investors. International Stem Cell Corporation has been steamrollering forward with incredible momentum in 2015, ever since the announcement in December of last year that the EU’s Court of Justice ruled in favor of the company’s core technology patent applications, declaring them to be effectively outside the scope of prohibitions on patenting embryonic stem cells, due to a laser-like focus on only ethical derivation of non-embryonic stem cells from unfertilized eggs. Ethically-derived sourcing is a key advantage for International Stem Cell Corporation, especially in the current environment, where a political and ethical debate about stem cell technology is heating up.

Highlights for the company so far this year include solid Q1 results reported in March, showing a 74 percent uptick in gross margins on the strength of a 76 percent increase in operating income from the company’s cosmeceutical and biomedical commercialization. Income growth to $1.62 million in revenue was led by a 5 percent sales jump at the company’s Lifeline Skin Care subsidiary, which specializes in providing rejuvenating skin care products based on nanosphere-enscapsulated proteins extracted from parthenogenetic stem cells. Additionally, the company made waves in the regenerative therapy industry with a talk given in May at the International Society for Cellular Therapy’s (ISCT) annual meeting by the company’s CSO, Ruslan Semechkin, Ph.D., highlighting the potential of hpNSCs for treating PD. The ISCT is the leading global association focused on innovative preclinical and translational cell therapy product development, and Dr. Semechkin’s talk on hpNSC therapy left a lasting impression on key industry participants who attended the Regeneration and Nervous System Repair session at the organization’s 21st annual meeting in Las Vegas.

This move to reverse split the common stock and up-list to a major exchange comes at an auspicious time for International Stem Cell Corporation as the company rockets towards commercialization of a potentially genuine treatment option for PD sufferers and their families. With GlobalData estimates on the PD treatment market running into the $5.3 billion range within the next seven years alone, growing at a compound annual rate of over four percent, International Stem Cell Corporation is poised to become one of the big names in PD treatment, especially considering the company’s ample IP position. The company has made a herculean effort thus far to globally secure its core technology, as well as specific pluripotent human parthenogenetic stem cell (hpSC) lines, with 16 issued patents and 91 pending applications spanning 15 patent families, as well as eight more pending applications across four other patent families related specifically to skin care products. International Stem Cell Corporation has even licensed an additional portfolio of 11 issued and 14 pending patents/applications covering eight patent families in order to further secure its broad-spectrum and rapidly developing hpSC treatment pipeline.

This pipeline includes developing the same hpNSCs used to treat PD, in order to provide stroke patients with the first real solution to this leading cause of adult disability, and the company already has robust preclinical evidence that injection of these highly-pure hpNSCs can be used to actually reverse functional deficits when applied even several weeks after the initial event. This one development would be a major commercial victory for the company and it would also largely establish the concrete viability of its parthenogenetic technology for creating commercial-scale, implant-ready cell banks for the ischemic (roughly 87 percent of cases) stroke treatment and other markets. Not to mention being a game-changer for the roughly 691,650 people every year in the U.S. who suffer from ischemic strokes. People whose only current option is costly, laborious, logistically difficult to implement, and often ineffective cognitive/functional rehabilitation. Commercial success in either PD or ischemic stroke would roundly validate the company’s underlying therapeutic approach for treating other diseases and disorders as well, potentially opening a floodgate for the company and allowing them the kind of financial muscle and industry clout needed to knock down additional targets with hpSC-based therapies.

The company’s hpSC technology is currently being developed for areas such as age-related macular degeneration via parthenogenetically-derived human retinal epithelium (RPE) cell therapy, as well as for corneal blindness and many other eye diseases/disorders via the production of corneal cells and whole corneal tissue. This same technology also shows great promise for treating metabolic (and other types of) liver diseases, such as Crigler-Najjar syndrome (inherited), and the company has already successfully created and characterized stem cell-derived liver cells under its CytoHep program, whose transplantation has been shown to effectively delimit the brain and nerve damage associated with Crigler-Najjar syndrome in preclinical animal models.

If one observes all of these emerging hpSC treatment vectors from a wide angle, it becomes strikingly apparent that we could potentially be treating a whole host of degenerative and other diseases/disorders with 100 percent ethically derived stem cell technology. International Stem Cell Corporation is at the forefront of this industry and the shoring-up of its share structure in anticipation of up-listing to a major exchange, in conjunction with the upcoming landmark clinical trials in PD, for which the company has already comfortably sustained the cost on and manufactured a cell bank of over 2.6 billion high-purity hpNSCs (enough to satisfy all foreseeable clinical trial needs), is an extremely bullish indicator to the investment community about where the company is heading.

Continued success of the company’s already commercialized cosmeceutical and biomedical product operations forms a key backdrop for International Stem Cell Corporation when it comes to funding ongoing clinical and preclinical efforts, further differentiating the company (alongside its strong IP position) from competitors.

Take a closer look by visiting www.internationalstemcell.com

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International Stem Cell Corp. (ISCO) Parkinson’s Treatment Just the Tip of the Iceberg for Stem Cell Technology Platform

August 3, 2015

The fact that novel stem cell therapy developer, International Stem Cell (OTCQB: ISCO), is now rapidly advancing from highly successful preclinical studies in Parkinson’s Disease (PD) using human parthenogenetic neural stem cells (hpNSC) derived from its proprietary stem cell technology platform toward a landmark phase 1/2a clinical study clinical study in Australia, has sparked renewed interest in the investment community regarding the company’s technology. After the publication of data on two proof of concept PD studies, demonstrating the safety and functional efficacy of the company’s human parthenogenetic stem cells (hpSCs) – an entirely new class of stem cells created using unfertilized eggs which substantially addresses the problem of cell transplant immune-rejection – the fundamental viability of ISCO’s hpSC approach and the potential for the upcoming clinical trial in PD have caused many in the investment community to dig deeper into ISCO’s dynamic platform.

Given the recent projection by research and consulting firm GlobalData that the PD treatment market alone will continue to grow alongside an ageing global population, running a CAGR of around four percent over the next several years, before hitting around $5.3 billion in 2022, the development of a viable treatment option by ISCO could be a major victory for the company and for patients; a victory which would also broadly legitimize the company’s existing clinical pipeline, while adding fuel to the fire of its existing commercialization. It is important to note that when it comes to PD, leading dopamine agonists like pramipexole and ropinirole, or Neupro/Leganto (rotigotine), work by merely imitating dopamine, stimulating the brain in a similar fashion and thus making up for the dopamine-producing cells that have died due to the onset of PD.

Dopamine agonist regimens do not represent a real treatment and merely mask the underlying disease. While such PD regimens return some percentage of motor and cognitive control to the patient, they are a far cry from the demonstrated ability of ISCO’s transplanted hpNSCs to both actively differentiate into new dopamine-producing neurons and simultaneously act as a neuroprotectant, addressing both the patient’s current symptoms and helping to stop further deterioration. ISCO’s approach is closer to that of regenerative medicine company Neuralstem, Inc. (NYSE: CUR), whose initial therapeutic product, derived from spinal cord neural stem cell lines, has received FDA orphan status for application in ALS, more commonly known as Lou Gehrig’s disease.

In ISCO’s case, the derivation and implementation methodologies are of particular interest, especially given the immune-matching aspects of the technology and its scalability potential, both in terms of producing large quantities of stem cells for transplant and with regards to addressing therapeutic avenues beyond the scope of the company’s current clinical pipeline. As the company moves out of the preclinical stage in its work on PD using hpNSCs, which have also shown significant promise as a legitimate treatment option for actually reversing the functional deficits associated with a stroke, when administered even weeks after the actual event, it makes sense to take a look at ISCO’s already functional commercial operations based on its stem cell platform technology. This is especially true given the company’s ongoing work with hpSC-derived human retinal epithelium (RPE) cells for treating retinal and corneal blindness, as well as its stem cell-derived liver cell (CytoHep) program, which is focused on developing metabolic liver disease therapies.

A solid five percent sales uptick for Q1 this year compared to 2014 reported by the company’s Lifeline Skin Care subsidiary – which leverages the same ethically-derived stem cell platform technology to create an extract for use in skin care products that have demonstrably shown an ability to improve elasticity, firmness, tone and other sought-after qualities – is a solid indicator of the company’s existing ability to generate revenue from its technology, even before commercialization of the clinical pipeline has been realized. With the global facial skin care market on track to hit somewhere in the neighborhood of $40 billion by 2019 (Transparency Market Research), driven in part by the fact that more and more men are beginning to show an increased awareness of and concern for their skin’s health, ISCO’s capacity to bring revolutionary products to market based on far more potent non-embryonic stem cells than the adult stem cells used by many other entrants to this burgeoning segment of the skin care market, has already placed the company in a class all its own.

A full lineup of facial skin care products, including an antioxidant polisher, brightening cleanser and exfoliating preparation, roundly back up Lifeline Skin Care’s eye firming complex and revitalizing moisture serum products, which are made possible by a nanotech encapsulation of the stem cell extract’s key proteins. This unique encapsulation of the proteins in an oily two-layer sphere, allows Lifeline products to penetrate deep into the middle layer of the skin, the dermis, where collagen and elastin (the main structural and elastic peptides that give the skin its youthful qualities) are produced.

Lifeline Skin Care customers rave about the results, expressing most often how much lighter and brighter their skin looks and feels. Given the continued success of the company’s clinical pipeline and the demonstrable efficacy of hpSCs in treating notoriously difficult CNS conditions like PD, it is not hard to understand why Lifeline Skin Care products have become so beloved by consumers. The idea of actually replacing skin proteins with high-potency, nanotech encapsulated, small-molecule and therefore readily absorbed proteins is a significant technological leap beyond what other stem cell-based skin care companies have been doing. Clinical laboratory studies showing a 46 percent increase in elastin, and a 48.5 percent on average increase for the two primary types of collagen when using Lifeline stem cell products, adds readily quantifiable weight to the documented expressions by consumers about how their skin feels brighter, more luminous, and healthier after using the products.

Operating income for ISCO from both aforementioned cosmeceutical commercialization and the company’s ongoing biomedical commercialization, which is executed under the company’s Lifeline Cell Technology subsidiary, was up some 76 percent in Q1 this year compared to 2014. Lifeline Cell Technology has quickly become an industry leader in supplying purified primary human cells and optimized cell culture reagents, and while this market is not as immediately lucrative as skin care, the long-term revenue generation potential as the stem cell industry evolves is considerable in its own right. With the best Q1 financial performance owing to the company’s cosmeceutical division, investors should take note of ISCO’s ability to generate revenues well before its clinical pipeline achieves commercialization, a feat which very few young biotechs can boast of.

Cancer is another huge area where we could see such technology revolutionize the way therapy is handled. Stem-cell transplantation following high-dose chemotherapy for instance, has emerged as an established treatment modality for a variety of hematologic malignancies, such as leukemia, lymphoma, and multiple myeloma. The company’s capacity to produce large volumes of immune-matched stem cells using its proprietary parthenogenetic derivation technology, at its GMP facility in Oceanside, California, is a key strategic and logistical advantage here as well. Even such innovators like clinical-stage biopharma BioLineRx (NASDAQ: BLRX) – which recently announced robust stem-cell mobilization capability with its lead oncology candidate, allowing for harvesting of enough cells needed to transplant from healthy volunteers into patients with hematological malignancies – are notably handicapped by comparison when it comes to cell source logistics.

Learn more about the company by visiting www.internationalstemcell.com

International Stem Cell Corp. (ISCO) Prepares to Begin Clinical Study of Novel Parkinson’s Disease Treatment Option

June 29, 2015

Imagine a world where there is no donor organ shortage, victims of spinal cord injuries can walk and weakened hearts are successfully replaced; this is the future of regenerative medicine, as outlined by the National Institute of Health. To obtain the massive promises of this revolutionary treatment option, however, it is necessary to successfully overcome the barriers associated with immune response, which have, to this point, severely hampered the advancement of cell replacement therapies. International Stem Cell Corporation (OTCQB: ISCO), through the continued development of its groundbreaking parthenogenesis stem cell technology, is addressing this limitation, potentially unlocking the door to significant advances in the field of regenerative medicine.

Parthenogenesis utilizes unfertilized human eggs to create pluripotent parthogenetic stem cells (hpSC) that can be immune-matched to millions of people. According to the company’s data, a relatively small number of hpSC lines could provide sufficient immune-matched cells to cover a large percentage of the world’s population, effectively minimizing the effects of autoimmune rejection and allowing for continued research into the massive potential upside of stem cell therapy. Unlike embryonic stem cells, which require the destruction of a human embryo, hpSC treatment also avoids many of the ethical issues commonly associated with stem cell research.

ISCO has identified a collection of potential diseases and conditions that could be effectively treated using its hpSCs, but the company’s leading indication is for the treatment of Parkinson’s disease. According to the National Parkinson Foundation, Parkinson’s disease is the 14th leading cause of death in the United States, and an estimated four to six million people suffer from the condition worldwide. Currently, there is no cure and limited treatment options for the disease, creating a significantly underserved market within the pharmaceutical industry.

“In the first quarter of 2015 we completed all the necessary preclinical studies of our Parkinson’s program and formally submitted our application to begin the first clinical study of this novel approach to treating this debilitating disease in humans,” stated Dr. Andrey Semechkin, Chief Executive Officer of ISCO. “We continue to expect to make significant progress during the rest of 2015 towards our goal of providing a viable treatment option for people with Parkinson’s disease.”

During preclinical studies, ISCO has demonstrated the safety and efficacy of treating Parkinson’s disease symptoms in animals with transplanted human parthenogenetic neural stem cells. Moving forward, the company will seek to begin its Phase I/IIa clinical studies through its wholly-owned subsidiary, Cyto Therapeutics Pty Ltd. For prospective shareholders, ISCO’s continued progression with preclinical and clinical studies makes the company an intriguing investment opportunity in the months to come.

For more information, visit www.internationalstemcell.com

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International Stem Cell Corp. (ISCO) Broad-Spectrum Applicability Of Ethically Derived Stem Cell Tech Underscored By Rapidly Advancing Parkinson’s Therapy

June 3, 2015

Degenerative disorders, which often strike our increasingly elderly populations, like the roughly 10k Baby Boomers in the U.S. hitting their 60s and retiring each day, are on the rise all over the planet, affecting more than 45 million people worldwide. Characterized by nerve cells progressively deteriorating to the point of cell death, a process which leads to a host of maladies ranging from Alzheimer’s and Parkinson’s disease, to ALS (amyotrophic lateral sclerosis) and Huntington’s disease, degenerative disorders currently have few, if any, real medical solutions available for patients.

In China, Europe and Japan, the same population and disease phenomena is occurring. Populations where people are living longer and where increased environmental exposure to various bio-accumulating toxins is causing a continued rise in the volume of a variety of neurological diseases and disorders, for which modern medicine remains largely incapable of providing substantial cures, and in some cases, even palliative treatments. This is why the regenerative medicine technology, based on an entirely new class of ethically manufactured stem cells, which is being aggressively developed toward full commercialization by International Stem Cell Corporation (OTC: ISCO), is so exciting.

Parthenogenesis is not a term most people today are familiar with, but the times they are a-changin’ – and they are changing fast. Degenerative disorders once thought incurable are now within striking distance of being effectively combated through the injection of human parthenogenetic neural stem cells (hpNSCs), which not only have all the best characteristics of other types of stem cell technologies, but lack their drawbacks as well. Thanks to the revolutionary work being done by ISCO with pluripotent stem cells (which that have the ability to mature into several different types of cells), chemically stimulating oocytes through a process where no embryo is ever created or destroyed, the dawn of ethical, high-volume, commercial stem cell technology that could be used to treat a wide variety of diseases, is at hand.

Derived from unfertilized human oocytes, the company’s stem cell lines can be made, via their proprietary process, into HLA (human leukocyte antigen) heterozygous “matched” and therefore histocompatible cells that won’t be rejected by the donor, giving this technology a serious advantage in a field still plagued by donor cell rejection. HLA homozygous hpSCs can also be produced which have been shown to exhibit histocompatibility across massive segments of the global human population, meaning that ISCO’s stem cell bank approach to the space could put the company at the forefront of supplying much-needed, large supplies of compatible donor cells to global markets, just as commercialization of this revolutionary technology dawns worldwide.

The upper limit on therapies involving stem cells is quite extraordinary, as these cells function like an atomized organ or other tissue transplant, repairing existing tissue systems by developing into healthy new cells that replace the damaged ones. In degenerative neurological disorders, this is truly a quantum leap, as no effective means exists to otherwise replace brain and other CNS tissue. The idea of injecting Parkinson’s disease (PD) patients with cultured neural stem cells (hpNSCs) that actually grow into new brain cells is extraordinary, and this same approach can be used to treat other neurological diseases as well, for many of which modern medical science can offer essentially only palliative care.

The current standard of care in PD is with dopamine agonists and drugs like oral levodopa (L-dopa), which has significant dosing issues that often lead to episodes where the symptoms of PD reemerge with a vengeance, particularly in patients who have been on an L-dopa regimen for over five years or more. In fact, 90 percent of young-onset sufferers treated for more than five years with L-dopa experience such episodes. L-dopa, while exhibiting fewer than other antiparkinsonian agents, has numerous adverse effects, including psychiatric ones, as well as the potential for the patient to develop dopamine dysregulation syndrome, and even eventual drug resistance. Needless to say, existing approaches are by no means effective solutions and the advent of an actual therapy for restoring the underlying tissue systems would be a paradigm shift of unprecedented magnitude. A shift whose shockwaves would likely propagate into multiple other degenerative disorders, especially considering the removal of ethical considerations about where the stem cells come from, given ISCO’s parthenogenesis production techniques.

The company’s hpNSCs help to repair the brain in several key ways, like responding to damaged cell signals and releasing anti-inflammatory molecules that help speed the recovery process. Directly addressing inflammation, which is one of the major concomitant symptomatological factors in PD, as well as forming new tissue by developing into new cells, are powerful properties that could rocket hpNSCs to the front of the line in PD therapy. Being able to give someone their life back through the application of this technology could change the way we think about degenerative disorders forever. The idea that we could take cases where a loved one has become effectively disabled – representing not just a serious loss for the individual and economy, but typically creating a significant burden for their families and the healthcare system – and actually restore them to nearly 100 percent functionality, represents one of the most exciting frontiers in biomedicine today.

ISCO’s sizeable preclinical GLP and non-GLP study data on hpNSCs, including brain transplant safety studies conducted in healthy and induced Parkinson’s disease animals, showed that not only were the hpNSC injections well-tolerated, with no sign of tumor or other abnormal growth formation at even high dosages, but that a distinct improvement to motor function resulted. These same studies further showed the neuroprotectant and recovery assistance functionality of hpNSCs, as well as a significant increase in dopamine levels, the primary agent which allows brain cells involved in movement to communicate with one another. National Parkinson Foundation data indicates that even in the roughly 15 percent of patients who develop young-onset Parkinson’s disease before the age of 50, the same loss of some 80 percent of dopamine-producing cells is observed before motor function impairment arises, something which clearly indicates the potential of ISCO’s technology.

ISCO is barreling towards their 1/2a clinical study in Parkinson’s disease over in Australia, which should kick off within the coming handful of months, as the company has already submitted the requisite CTX (Clinical Trial Exemption) application needed to commence this landmark study. The high safety levels of this technology and emerging knowledge of the causes and symptomatology of degenerative disorders, could even lead to developing hpSCs into frontline preventative treatments in patients who are identified as at risk or in the early stages of a given disease.

At any rate, ISCO has their eye on the prize and has already completed manufacturing a large supply of over 2.6 million clinical-grade hpNSCs for the Australia Parkinson’s study, enough to easily handle any foreseeable trial requirements, and further validating their UniStemCell bank approach to the market. Paired up with their proprietary parthenogenesis process for manufacturing cells, a regionalized stem cell bank franchising architecture could be a significant source of future revenues for the company, serving scientists and populations across the country and around the world with an essential stem cell line banking framework. Such a framework, while helping to further validate a growing library of hpSC lines with many people working on and developing them, could also develop into a serious royalty-generating engine fueled by diverse, emergent cellular therapeutics.

ISCO has a strong IP position with numerous patents and filings under their belt too, spanning everything from specific pluripotent hpSC lines and production methods, to cell differentiation and research methods, as well as therapeutic and commercial uses. Like the 16 issued and 91 pending patent applications across 15 different patent families, as well as 8 patents pending across 4 different families, covering their stem cell-based Lifeline Skin Care (http://www.lifelineskincare.com/) products.

For more information, please visit www.internationalstemcell.com

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International Stem Cell Corp. (ISCO) Scheduled to Present at International Society for Cellular Therapy Annual Meeting

May 27, 2015

International Stem Cell Corp., a California-based biotechnology company developing novel stem cell based therapies and biomedical products, this morning told investors that it has been chosen to deliver an oral presentation on its preclinical studies in Parkinson’s at the 21st annual meeting of the International Society for Cellular Therapy in Las Vegas. ISCO’s chief scientific officer, Ruslan Semechkin, Ph.D., will discuss the data at the “Regeneration and Nervous System Repair” session at 11:45 a.m. on May 30, 2015 in a presentation entitled “Human Parthenogenetic Derived Neural Stem Cells for the Treatment of Parkinson’s Disease.”

ISCO has built an extensive preclinical dataset from a series of GLP and non-GLP studies on human parthenogenetic neural stem cells (hpNSC). The dataset includes safety studies, where hpNSC were transplanted into the brains of healthy animals, and proof-of-principle studies where the cells were transplanted into animals with induced Parkinson’s disease symptoms. The studies show that hpNSCs are well tolerated with no evidence of tumor formation even at very high doses and have the ability to protect and recover neurons, increase dopamine levels and improve the motor function. The Company has submitted a CTX application to the Australian regulatory authorities and plans to begin the phase 1/2a clinical study in Parkinson’s disease within the next few months.

The International Society for Cellular Therapy (ISCT) is a global association driving the translation of scientific research to deliver innovative cellular therapies to patients. ISCT is one of the only organizations focused on pre-clinical and translational aspects of developing cell therapy products. As such, ISCT helps academic, government and biotech/pharma sectors transform research into practice and product. Over 1200 international delegates including clinicians, scientists and regulatory experts are expected to attend this year’s meeting.

For more information on ISCO and its hpNSCs, visit www.internationalstemcell.com

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International Stem Cell Corp. (ISCO) Utilizing Revolutionary Technology to Unlock the Power of Regenerative Medicine

May 26, 2015

An aging population is currently highlighting the considerable limitations of the medical industry. According to the Mayo Clinic, treatments are increasingly unable to keep pace with the needs of patients, with clinicians only having access to medications or devices that can manage symptoms. However, advances in developmental and cell biology, immunology and related fields have unlocked huge potential for the industry, and regenerative medicine looks to be the game-changing solution.

Despite its promise, regenerative medicine faces significant hurdles moving forward. In particular, immune rejection of transplanted cells has severely limited the huge potential of stem cell therapy. International Stem Cell Corporation (OTCQB: ISCO), through its powerful new stem cell technology, could be on the cusp of overcoming these limitations, opening the door for major advances in the medical market.

Parthenogenesis, ISCO’s proprietary stem cell development process, has allowed the company to develop a new class of stem cells, known as human parthenogenetic stem cells (hpSCs), which possess the most favorable characteristics of the existing classes. Through this technique, ISCO is able to create cells that are exactly matched or histocompatible with large segments of the human population, limiting the risk of immune rejection during treatment.

ISCO has made noteworthy strides towards the commercialization of its cell therapy treatment this year, capturing the attention of industry experts around the globe.

“In the first quarter of 2015 we completed all the necessary preclinical studies of our Parkinson’s program and formally submitted our application to begin the first clinical study of this novel approach to treating this debilitating disease in humans,” stated Andrey Semechkin, Ph.D., Chief Executive Officer and Co-Chairman of ISCO.

Highlights from the company’s business activity thus far in 2015 include the completion of preclinical studies and submission of an application to begin human trials in Australia, completion of manufacture of a bank of 2.6 billion human cells for use in clinical trials and the approval of a Japanese patent covering parthenogenetic methods of stem cell creation, meaning ISCO now has patent protection in all three major world markets (US, EU and Japan).

“We continue to expect to make significant progress during the rest of 2015 towards our goal of providing a viable treatment option for people with Parkinson’s disease,” continued Semechkin.

According to Florida Hospital, Parkinson’s disease affects up to one million people in the United States, with doctors diagnosing as many as 60,000 new cases each year. Upon completion of clinical trials, the potential market for ISCO’s parthenogenetic cell creation is effectively limitless. As the company continues towards marketization for the treatment of Parkinson’s disease, look for substantial opportunities for growth within the medical industry in the years to come.

For more information, visit www.internationalstemcell.com

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International Stem Cell Corp. (ISCO) Unique Stem Cell Tech’s Immense Therapeutic Potential Continues To Be Demonstrated

May 18, 2015

International Stem Cell Corp., a developer of ethical stem cell therapies (as well as biomedical products) based on their pioneering of an entirely new class of stem cells, hpSCs, or human parthenogenetic stem cells, which offer significant advantages over existing stem cell technologies, continues to see the broad spectrum potential of their technology across the company’s entire therapeutic pipeline.

Parthenogenesis is a form of aesexual reproductive cell division where no fertilization occurs, meaning that no viable embryo is created or destroyed. Derived from unfertilized human eggs (oocytes) and differentiated using a proprietary, patented and chemically-defined process, ISCO’s hpSCs are completely ethical and yet also have superior immune matching (low cell transplant rejection rate) and histocompatability (tissue compatibility) properties compared to existing stem cell technologies. In addition, hpSCs are highly pluripotent, or differentiable into many different cell types, meaning they can be used to treat a broad range of diseases. These novel stem cells are also easily proliferated, meaning large quantities can be grown in the lab and the technology thusly represent an effective, practical solution for developing and executing cost-effective transplantation-based therapies, even for large populations of patients.

Indeed, the fact that ISCO’s hpSC technology allows for derivation of HLA (human leukocyte antigen, the major histocompatibility complex which restricts antigen presentation) homozygous hpSCs, even a relatively limited set of hpSC lines could be used to generate huge quantities of immune-matched cells that would correspond to vast swathes of the human population. This innovative technology captures all the best aspects of other extant stem cell technologies, like adult stem cells, embryonic stem cells (hESC) and induced pluripotent stem cells (iPS), but does not suffer from any of the ethical or logistical limitations. This means that ISCO is essentially the tip of the spear in a therapeutically realistic war against dreaded diseases like Parkinson’s, with real solutions in the offing for ischemic (acute) stroke, as well as metabolic liver diseases (using stem cell-derived liver cells – CytoHep), and the crippling impairment of corneal and retinal blindness (using human retinal epithelium and corneal cells – RPE cells and CytoCor respectively).

With FDA clearance for the company’s hpSC technology already under their belt, as well as a soon to begin Phase 1/2a clinical study in Parkinson’s using their human parthenogenetic neural stem cell technology (ISC-hpNSC), including the already completed production of a 2.6 billion cell stem cell bank that will cover all clinical trial requirements, ISCO is within striking distance of having a viable therapeutic solution to Parkinson’s disease. ISCO’s progress in developing a therapeutically realistic solution to this increasingly prevalent CNS disease no doubt appears as a beacon of hope on the horizon to the millions of people around the world whose lives have been shattered by this disease, which currently impacts the lives of as many as seven million people and takes a heavy toll on their families (not to mention national healthcare systems), due to a progressive loss of nerve cells in the victim’s brain that leads to severe motor and mental impairment.

According to one National Parkinson Foundation study, as many as 9.3 million people worldwide will be living with Parkinson’s disease (PD) by 2030 and estimates for the U.S. alone show that as many as 60,000 new cases crop up each year. Market analysis from last year put the (note that these are typically only marginally effective) 2012 PD therapy market at around $3.56 billion globally ($1.15 billion U.S.) with only 2.18 million cases reported. Conservative estimates forecast that the diagnostics/therapy market will grow to $5.26 billion worldwide ($2.33 billion U.S.) within the next seven years alone, using extrapolated market size estimates on a target of only 2.89 million cases.

The profound utility of ISCO’s ISC-hpNSC technology doesn’t stop at PD either, the same ability of these cells to simultaneously differentiate into dopaminergic neurons, while also expressing brain-protecting neurotrophic factors (neurotrophins are key proteins which help neurons survive and thrive), makes them ideal for treating other CNS disorders and diseases. New results which show ISC-hpNSCs may not only reduce but even reverse the symptoms of neurological dysfunction could prove huge for people who have suffered from a stroke, especially considering that the 795,000 plus strokes which occur each year leave those who manage to survive with zero currently approved treatment options, aside from grueling and generally only partially effective physical rehab.

Peer-reviewed publications showing the superior immunological properties of hpNSCs compared to other neural stem cells is also an extremely promising advantage for ISCO and the company has plans to investigate this abundant potential in further detail via upcoming studies. A presentation of extant data on the potential of hpNSCs, including how they are actually attracted to the site of an injury by naturally-occurring molecular chemistry signals, reducing swelling and forming new brain tissue, is set to take place at an upcoming scientific conference and will be announced in the very near future. For ischemic stroke (which accounts for nearly 90% of all stroke cases), the $1.2 billion diagnosis and therapy market as of 2013 set to hit $1.9 billion in five years (6.3% CAGR), where the immediacy of therapeutic response time is directly proportional to recovery outcomes (success), the value of hpNSC therapy, which has been shown in pre-clinical work to reverse associated functional deficits even several weeks after the stroke, is substantial.

A highly effective therapy for acute stroke that can be applied even weeks after the actual stroke would be a major game changer and could help propel ISCO to the top of the stem cell industry.

Dig deeper into this innovative stem cell therapy developer at www.internationalstemcell.com

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International Stem Cell Corp. (ISCO) Posts Q1 Business Highlights, Financial Results

May 13, 2015

International Stem Cell Corp., a California-based biotech company developing novel stem cell-based therapies and biomedical products, today issued a business update and posted its financial results for the first quarter of 2015.

Business updates for the first quarter of the year include:

• Completed the required preclinical studies and submitted a clinical trial exemption application to the Australian Therapeutics Goods Administration (TGA) to begin the phase 1/2a clinical study of the company’s cell therapy for the treatment of Parkinson’s disease. To be administered through the company’s wholly owned Australian subsidiary, Cyto Therapeutics Pty Ltd.

• Completed the manufacture of the bank of clinical-grade human neural stem cells for use in the Parkinson’s disease clinical trial. The cell bank contains more than 2.6 billion human cells, sufficient to meet the company’s foreseeable clinical trial requirements.

• Japan Patent Office granted International Stem Cell’s patent covering methods of making a bank of human stem cells from parthenogenetically activated eggs significantly strengthening and expanding the company’s intellectual property to now include Japan as well as the United States and the European Union.

“In the first quarter of 2015 we completed all the necessary preclinical studies of our Parkinson’s program and formally submitted our application to begin the first clinical study of this novel approach to treating this debilitating disease in humans,” Andrey Semechkin, Ph.D., CEO and Co-chairman of International Stem Cell, stated in the news release. “We continue to expect to make significant progress during the rest of 2015 towards our goal of providing a viable treatment options for people with Parkinson’s disease.”

On the financial side, International Stem Cell achieved first-quarter revenue of $1.62 million; Lifeline Skin Care increased 5% while Lifeline Cell Technology sales decreased by 8%. Operating income from cosmeceutical and biomedical markets grew 76% compared with the first quarter of 2014. Gross margin improved to 74%

The company narrowed its first-quarter 2015 net loss to $1.29 million compared to a net loss of $1.44 million reported in the year ago quarter. International Stem Cell ended the first quarter of 2015 with cash of $0.61 million.

For more information, visit www.internationalstemcell.com

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International Stem Cell Corp. (ISCO) – Developing Novel Stem Cells for Research and Therapy

May 4, 2015

The International Stem Cell Corp. is a fast growing North American biotechnology company focused on developing stem cell based therapies and biomedical products. The company has developed an influential new stem cell technology called parthenogenesis that promises to substantially improve the field of regenerative medicine by addressing the problem of immune-rejection.

As part of its therapeutic pipeline, ISCO’s scientists are focused on using the stem cells developed to treat diseases of the eye, liver and central nervous system, in areas where cell therapy has been clinically proven yet treatment options are limited by the availability of safe immune-matched human cells or tissue. The company’s lead development candidate is a human neural stem cell product to treat Parkinson’s disease (PD). Preclinical safety and efficacy data was recently presented at the annual meeting of the Society for Neuroscience And a Phase I/IIa clinical study is expected to begin in the near future. In the trail ISCO will treat people with moderate Parkinson’s with a one-time transplant of neural stem cells. In animal studies the cells have been shown to be safe and also be able to reverse some of the symptoms of the disease. Interim results from this clinical trial could be available as early as the end of this year. The idea that a one-time injection of new cells can “cure” Parkinson’s disease has the potential to revolutionize the field. The Company also recently announced encouraging results from a study using the same neural stem cells to treat stroke.

With parthenogenesis, ISCO has developed a proprietary technique for creating histocompatible stem cells (hpSC). Parthenogenesis uses unfertilized human eggs to create parthenogenetic stem cells that can be immune-matched to millions of people. This process results in the cells inheriting a matching set of human leukocyte antigen (HLA) genes, which drastically reduces the possibility of the resulting cells being rejected by an individual’s immune system after transplantation, making a single cell line suitable for treating millions of individuals of differing genders, ages and racial background. hpSCs avoid ethical issues associated with the use or destruction of viable human embryos, and a fairly small number of such cell lines could provide enough immune-matched cells to cover a sizeable percentage of the world’s population.

Histocompatible stem cells offer the potential to create the first true stem cell bank, UniStemCell. This could be the foundation of ISCO’s research as well as the life science industry’s first collection of non-embryonic histocompatible human stem cells for research and commercial use.

In mid-March 2015, ISCO revealed that the Japan Patent Office had granted it a patent that covered its methods of making a bank of human stem cells from parthenogenetically activated eggs. The new patent extends the reach of the company’s intellectual property portfolio beyond the United States and European Union making it a very appealing partner.

Over time, ISCO could generate revenue from universal stem cell bank franchises across populations and from scientists accessing these lines. This would also provide additional validation of the hpSC lines as they will be tested and developed by others across a range of potential applications and, longer-term, will provide the company with royalties from the sales of each successful, hpSC-derived cellular therapeutic.

For more information, visit www.internationalstemcell.com

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International Stem Cell Corp. (ISCO) Demonstrates Treatment of Parkinson’s Disease in Cell Transplantation

April 21, 2015

Today before the opening bell, International Stem Cell Corp., a biotechnology company developing novel stem cell based therapies and biomedical products, announced publication of results of two proof-of-concept studies that validate the safety and efficacy of the company’s readily expandable stem cell derived treatment of Parkinson’s disease in both non-human primate and rodent animal models.

“The publication of these data in the peer-reviewed and highly-respected journal, Cell Transplantation, brings to a conclusion the preclinical stage of our Parkinson’s disease program. The data clearly support the premise that parthenogenetic neural stem cells can be effective in treating the symptoms of Parkinson’s disease and, along with the previously reported safety data, forms the basis of our decision to move into the clinic,” stated Ruslan Semechkin, Ph.D., the Company’s Chief Scientific Officer. “We look forward to providing an update on the status of our regulatory submission to the Australian government in the near future.”

In addition to successfully treating animals with induced Parkinson’s disease symptoms by transplanting human parthenogenetic neural stem cells (hpNSC), the company observed there were no deformations, tumors or involuntary muscle movements (dyskinesia). The studies further show that transplants of human parthenogenetic neural stem cells led to improvement of dopamine levels and increased cytokine levels.

The article and abstract can be found at: http://www.ingentaconnect.com/content/cog/ct/2015/00000024/00000004/art00010

ISCO has built a comprehensive preclinical safety dataset from a series of GLP and non-GLP studies on hpNSC. According to today’s press release, the company has submitted a Clinical Trial Exemption (CTX) application to the Australian regulatory authorities and plans to begin the phase 1/2a clinical study within the next few months.

For more information on the company, visit www.internationalstemcell.com and www.companyblog.intlstemcell.com

International Stem Cell Corp. (ISCO) to Present Final Safety and Efficacy Results from Parkinson’s Disease Program at AAN Annual Meeting

April 14, 2015

Today before the opening bell, International Stem Cell Corp., a California-based biotechnology company developing novel stem cell based therapies and biomedical products, announced that it will be giving a platform presentation on its preclinical studies in Parkinson’s at the 2015 American Academy of Neurology Annual Meeting in Washington, DC. Ruslan Semechkin, Ph.D., ISCO’s chief scientific officer, will discuss the data at the “Parkinson’s Disease” scientific session (s48.007), on Thursday, April 23rd at 4:45 pm in a talk entitled “Neural Stem Cell Based Therapy for Parkinson’s Disease.”

“These animal studies strongly suggest that the transplantation of human parthenogenetic neural stem cells (hpNSCs), for the treatment of Parkinson’s will be efficacious, safe and well tolerated,” stated Ruslan Semechkin, Ph.D. “The data further elucidate our platform and help solidify expectations for our planned Phase 1/2a studies in humans.”

The data presented are from two safety studies, where human parthenogenetic neural stem cells (hpNSC) were transplanted into the brains of healthy animals, and a proof-of-principle study where the cells were transplanted into animals with induced Parkinson’s disease symptoms. The studies show that hpNSCs migrated to the injured brain area, increased dopamine levels, protected and recovered neurons and improved the motor function. Additionally, at the conclusion of the twelve month non-human primate safety study, no evidence of teratoma formation or ectopic tissue was found in any animals that received the human cell transplants.

ISCO has built a comprehensive preclinical safety dataset from a series of GLP and non-GLP studies on hpNSC. The Company has submitted a CTX application to the Australian regulatory authorities and plans to begin the phase 1/2a clinical study within the next few months.

For those not familiar with them, hpNSCs are a novel therapeutic cellular product derived from International Stem Cell Corporation’s proprietary human pluripotent stem cells. Neural stem cells work to repair the brain in several ways. The cells are attracted to the site of injury and in response to signals released by the damaged tissue release a range of molecules that reduce inflammation and trigger the recovery process. Neural stem cells also have the ability to generate new cells to replace those that are either dead or dying enabling the formation of new tissue. In this way the hpNSCs act as coordinators of all the various activities necessary to recover brain function.

To learn more about International Stem Cell Corp. and its technologies, visit www.internationalstemcell.com

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International Stem Cell Corp. (ISCO) Uses Neural Stem Cells to Reverse Neurological Stroke Symptoms

April 7, 2015

International Stem Cell Corp., a California-based biotechnology company developing novel stem cell based therapies and biomedical products, today issued a press release to update the medical and investor communities about its recent experiments. Using animal models, the company has successfully demonstrated how human parthenogenetic neural stem cells (ISC-hpNSC) can significantly reduce neurological dysfunction after a stroke.

“With no approved treatments for neurological dysfunction, individuals who have suffered a stroke have few treatment options available beyond physical rehabilitation following recovery,” stated Ruslan Semechkin Ph.D., the company’s chief scientific officer. “These new results are highly encouraging, suggesting that ISC-hpNSC may have significant ability to not only reduce but also reverse these neurological symptoms of dysfunction. These findings not only broaden the future potential use of our neural stem cells beyond Parkinson’s disease but also offer hope to a patient population with a significant unmet medical need.”

Neural stem cells work to repair the brain in several ways. The cells are attracted to the site of injury and in response to signals released by the damaged tissue release a range of molecules that reduce inflammation and trigger the recovery process. Neural stem cells have the ability to make the various neurological cell types to replace the dead and dying cells necessary for the formation of new brain tissue. In this way the hpNSCs act as coordinators of all the various activities necessary to recover brain function.

ISCO’s stroke program uses the same neural stem cells as the company’s Parkinson’s disease program, derived from the company’s human parthenogenetic stem cells using a cGMP method based on the protocol published in Nature Scientific Reports in March 2013 (click here). Parthenogenetic neural stem cells have been shown in peer-reviewed publications to have superior immunological properties to other neural stem cells. The complete dataset will be presented at an upcoming scientific conference to be announced separately. Further studies investigating the potential for treating stroke are planned.

According to the National Stroke Association stroke is a leading cause of death in the United States, killing nearly 130,000 people each year, and is a leading cause of serious, long-term adult disability. Approximately 795,000 strokes will occur each year, one occurring every 40 seconds, and taking a life approximately every four minutes. Approximately two million brain cells die every minute during stroke, increasing the risk of permanent brain damage, disability or death. The estimated direct and indirect cost of stroke in the United States in 2010 is $73.7 billion.

For more information on International Stem Cell Corp., visit www.internationalstemcell.com

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International Stem Cell Corp. (ISCO) Reports 2014 Q4 and Year-End Results, Schedules Conference Call for Wednesday

March 31, 2015

Today, International Stem Cell Corp., a California-based biotech developing novel stem cell-based therapies and biomedical products, updated investors with latest happenings and reported its fourth quarter and year-end financial results for the period ended December 31, 2014.

Q4 highlights:

• The Court of Justice of the European Union ruled in favor of the Company’s EU patent applications, opening the way to the issuance of ISCO’s core technology patents in the EU in 2015 and significantly strengthening the Company’s intellectual property estate
• Received clearance from the U.S. Food and Drug Administration, in an important ruling, for ISCO’s human parthenogenetic stem cell line for investigational clinical use; the FDA accepted the use of parthenogenetic stem cells as a starting material for the development of human cellular therapeutics
• Presented results from preclinical studies of ISC-hpNSC, ISCO’s human parthenogenetic neural stem cell clinical product, including long-term safety data and proof-of-concept efficacy data in Parkinson’s disease, at Neuroscience, the annual meeting of the Society for Neuroscience in Washington D.C.
• Awarded the designation of one of America’s fastest growing companies as highlighted in Deloitte’s 2014 Technology Fast 500™ list in recognition of ISCO’s rate of growth in sales over the last several years.

Also notable, in January of this year, the company announced the completion of the required preclinical studies and plans to begin a phase 1/2a clinical study of its ISC-hpNSC cell therapy in Parkinson’s disease in Australia. As part of this expansion, ISCO has formed an Australian subsidiary, Cyto Therapeutics Pty Ltd.

FY 2014 Financial highlights:

• $7.02 million in revenue for the year ended December 31, 2014, an increase of 14% compared to 2013; Lifeline Skin Care sales up 9% and Lifeline Cell Technology sales up 19%. Gross margin stable at 73%
• Operating income from Lifeline Skin Care and Lifeline Cell Technology subsidiaries up 55% to $1.02 million for the year ended December 31, 2014, compared with $0.65 million in 2013.
• Average net cash used in operating activities of $0.54 million per month for the year ending December 31, 2014; The company ended 2014 with cash of $1.11 million

“We delivered on some very important milestones in the last three months of 2014, including bringing to a successful conclusion our patent applications with the CJEU and obtaining clearance for the clinical use of our stem cell lines from the U.S. FDA,” stated Andrey Semechkin, Ph.D., CEO and Co-chairman of ISCO. “These achievements add further momentum to both our Parkinson’s program and our business development plans. We expect to make more progress in 2015, including starting our clinical trial in Parkinson’s disease patents and to potentially report interim data before the end of 2015.”

Simon Craw PhD, Executive Vice President, Jay Novak, Chief Financial Officer and Ruslan Semechkin PhD, Chief Scientific Officer, of International Stem Cell will host the conference call scheduled for tomorrow. To attend the call, please use the dial in information below:

Conference call and webcast details

Date: Wednesday April 1, 2015
Time: 11:00 a.m. ET
Toll-free (US only): 1-888-329-8877
Toll/International: 1-719-457-2648
Conference ID: 1112311
Webcast: http://public.viavid.com/index.php?id=113470

Please log in at least 10-minutes before the call start time to ensure timely participation.

A playback of the call will be available from 4/1/15 at 2:00 pm Eastern Time to 4/15/15 at 11:59 pm Eastern Time.

Teleconference Replay Details:
Toll free: 1-877-870-5176
Toll/International: 1-858-384-5517
Replay Pin Number: 1112311

For more information on International Stem Cell Corp., visit www.internationalstemcell.com

International Stem Cell Corp. (ISCO) Eyeing $5.3 Billion by 2022 Parkinson’s Treatment Market, Continues Advancing Unique Stem Cell Technologies

March 24, 2015

International Stem Cell Corp. is a biotech company with key stem cell technologies under their belt and a clear focus on therapeutic and clinical product development. The company has a slew of long-term therapeutic opportunities on the table, as well as two important, revenue-generating subsidiaries already running which could become even more significant revenue engines as the company’s development pipeline progresses further. The company’s human parthenogenetic stem cell (hpSC) technology has several advantages compared to other stem cell technologies in existence today, like embryonic, induced pluripotent, or adult stem cells, with equivalency to embryonic stem cells when it comes to generic diseases and superior immune matching to all three. And unlike induced pluripotent stem cells for instance, hpSCs have not been genetically reprogrammed or manipulated by viruses, giving them vastly superior long term viability as a treatment vector.

ISCO’s unique, ethical techniques of chemically stimulating (parthenogenesis) unfertilized female gametocytes (egg cells), known as oocytes, means that no viable embryo has been created or destroyed in the process of creating their hsPCs. Furthermore, specific differences in activation techniques can yield either HLA (human leukocyte antigen) heterozygous or HLA homozygous hpSCs, which are histocompatible with the donor, or with large segments of the human population respectively. The combined benefits from being immunomatched and the ethical nature in which their hsPCs are produced, sets the ISCO stem cell technology apart from the competition when it comes to developing truly 21st century cell-based therapies.

These key advantages have allowed ISCO to rapidly develop brain, liver and corneal (eye) cells to treat Parkinson’s disease (and potentially other neurological disorders), the effects from various causes of liver damage, and also address the millions of people worldwide who need corneal transplants each year, due to various eye diseases or injuries. International Stem Cell has already seen some incredible R&D milestones, well beyond their core small molecule-based differentiation methods used to produce large batches of extremely pure cells in a controlled manner, which has allowed the company to seriously address a host of clinical stem cell usage requirements, unlike many of the company’s competitors who are unable to produce high quality stem cells in large quantities. From ISCO’s creation of dopaminergic neurons for the treatment of Parkinson’s, whose ability to engraft and produce dopamine (as well as to produce brain-protecting neurotrophic factors) has been successfully shown in animal model studies, to the creation of human hepatocyte-like cells that have been shown in animal models to engraft, mature and express key human liver proteins, the company has seen their hsPCs quickly transform the concept of what is possible in stem cell therapies today. The creation of self-assembling human corneas, including all the requisite cell layers needed to make the product ideal for transplants or drug toxicology testing, perhaps shows best just how powerful ISCO’s technology really is and what lies in store for future developments.

ISCO’s high capacity production techniques have made it possible for the company to create the UniStemCell bank, which is the life science industry’s first real stem cell bank of non-embryonic and histocompatible human stem cells, making possible both commercial use and extensive research work. The company’s master stem cell bank carries fifteen key hpSC lines, one of which has the most common immune type (haplotype) and is immune-matched to some 70 million people on earth. In February of this year, International Stem Cell completed manufacturing all the clinical-grade hpNSCs (human parthenogenetic neural stem cells) required using their patented process which are needed for their upcoming Phase 1/2a clinical trial in Parkinson’s disease in Australia, which will be conducted via their localized Cyto Therapeutics Pty Ltd. subsidiary. This trial will not only further document the efficacy of the company’s stem cell technology, it will form the basis for regulatory submission to the Australian Therapeutics Goods Administration (TGA) and for further clinical hpNSC studies in Parkinson’s in the United States.

Already covered in pre-IND meetings with the FDA, the company’s master cell bank of hpNSCs are produced with full cGMP compliance and relevant chemistry and manufacturing controls, and the parthenogenetic line derived undifferentiated cells has already been cleared by the FDA for use in clinical trialing. Given that the company has produced and cryopreserved enough material at their state-of-the-art, GMP-compliant facility in Oceanside (CA), required to serve all anticipated needs through their clinical trials (in conjunction with their current production-scale capabilities), management is confident that the company will see great success with their Phase 1/2a and subsequent Phase 2b/3 trials.

With considerable and growing revenues from their B2B Lifeline Cell Technology operations, which provide various purified primary human cells and optimized reagents for cell culture to numerous industry operators, as well as from their Lifeline Skin Care® operations, which develops and markets anti-aging skin care solutions based on hpSC derived growth factors and peptides, ISCO has the kind of clinical development capital backstopping most other developers lack. However, as with all such clinical development work, the overall costs to implement all related business, operating and development plans can be enormous. The deal with Lincoln Park Capital Fund, LLC to sell up to $10.25 million of common stock has helped to support operations, with a $1.588 million raise (8.2M shares) during the nine months ended September 30, 2014 (subsequent private placement agreements with Lincoln Park means the company won’t be selling any more shares to Lincoln Park until March 2016). Q3 2014 also saw insider skin in the game increase, with some 10.4 million shares sold to the CEO and Board Co-Chair Dr. Andrey Semechkin, and Dr. Ruslan Semechkin, as well as the CSO and a company Director, which brought in an aggregate $1 million.

Over a million people in the U.S. alone live with Parkinson’s and incident rates are set to continue rising as an ageing population stimulates a roughly 4% CAGR according to a recent report published by GlobalData. The treatment market for Parkinson’s alone is on track to hit $5.3 billion by 2022 and ISCO is one of the clear front runners in the game today with a therapeutic option emerging that has the potential to even reverse the effects, but it will take investors who understand the longer-term upside to help further support the company’s clinical development initiatives.

Take a closer look at the company by visiting www.internationalstemcell.com

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International Stem Cell Corp. (ISCO) Granted Japanese Patent for Key Stem Cell Technology

March 17, 2015

International Stem Cell Corp., a California-based biotechnology company developing novel stem cell based therapies and biomedical products, today reported that the Japan Patent Office has issued ISCO’s patent covering methods of making a bank of human stem cells from parthenogenetically activated eggs. This win significantly bolsters the company’s intellectual property position and ability to form partnerships in Japan.

“The new patent strengthens our position as a leader in regenerative medicine. With the potential to avoid one of the fundamental problems of tissue and cell therapy, immune-matching, and having been shown to be more genetically stable than iPS cells, our human parthenogenetic stem cells hold potential significant therapeutic value,” said Ruslan Semechkin, PhD, ISCO’s chief scientific officer. “The new patent also extends the geographic reach of our broad IP portfolio beyond the US and EU making us a more attractive partner for Japanese pharmaceutical companies.”

ISCO’s patent covers a new method of creating stem cells that combine many of the benefits of embryonic stem cells with induced pluripotent stem cells and can be used to generate virtually unlimited quantities of human cells. The company is currently using this technology to develop treatments for a number of indications where cell therapy has been demonstrated to be effective but there is insufficient supply of safe, functional cells. Preclinical safety and efficacy data from the company’s Parkinson’s disease program was recently presented at the Society for Neuroscience annual meeting, and a Phase I/IIa clinical study in Parkinson’s disease is anticipated to begin in the near future.

Along with ISCO’s substantial collection of US patents, and the recently announced resolution by the European Union Court of Justice in favor of the company’s EU patent applications, this new Japanese patent provides intellectual property protection and licensing opportunities for ISCO in the three largest healthcare markets.

For more information, visit www.internationalstemcell.com

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International Stem Cell Corp. (ISCO) Moving Ever Closer To An Effective, Regenerative Multipotent Cell Treatment For Parkinson’s Disease

March 2, 2015

In the U.S. alone each year somewhere around 60k people are diagnosed with the crippling degenerative central nervous system (CNS) disorder known as Parkinson’s disease, which is brought on by an as-yet poorly understood cascade death of dopamine-generating cells in the midbrain. Roughly 0.3% of the entire population, or nearly one million Americans, currently lives with this life-shattering disorder. That’s more than multiple sclerosis, muscular dystrophy, and Lou Gehrig’s disease combined.

Parkinson’s is the kind of CNS disorder that can destroy an entire family, devastating a family member and rendering them unable to effectively care for themselves, as the disorder is most commonly characterized by severe diminishment of motor control, uncontrollable limb rigidity and shaking, as well as considerable difficulty just walking or moving around. Later on in the progression of Parkinson’s, sensory and emotional problems arise, with sleep deprivation and depression being all too common. Eventually, the patient often develops thoroughly debilitating dementia as well and Parkinson’s has become a dreaded thief that can rob a family of their loved ones, and for which there are currently only extremely limited/costly treatment options.

Worldwide the incident rate is more difficult to get a handle on, but the Parkinson’s Disease Foundation estimates that as many as 10 million people worldwide are currently afflicted and that in the U.S., total direct and indirect costs, including treatment and lost wages, amounts to around $25 billion each year. With medications to help patients cope running around $2.5k a year for most and only somewhat effective therapeutic surgeries running somewhere in the neighborhood of $100k, there is immense demand for a more effective and less invasive solution.

International Stem Cell Corp. (OTCM:ISCO), a small publicly-traded biotech developer based in California with around 47 full-time employees, 23.4% of whom are Phd/MDs, may have just such a solution in the works thanks to their decade-plus pioneering in ethical pluripotent stem cell technology. The company’s proprietary human parthenogenetic stem cell (hpSC) platform technology, which is clearly differentiated from induced pluripotent stem cell (iPS) technology due to zero manipulation of the cellular genome and thus does not bear the safety and regulatory burdens associated with iPS approaches, is now rapidly advancing towards ISCO’s first clinical product, human parthenogenetic neural stem cells (hpNSC).

Recently vindicated in the EU via a final and definitive ruling by the EU’s highest court, the Court of Justice of the European Union, in a decision which roundly confirmed the earlier opinion issued by the Advocate General in 2014, the company’s core technology patent applications are not prohibited, or even covered under the EU’s prohibition on patenting embryonic stem cells. This decision clears the way for commercial rollout in the Eurozone of ISCO’s rapidly advancing hpNSC technology, as parthenogenetic stem cell’s legally patentable status is now clearly differentiated from still-banned embryonic stem cell patenting.

Earlier this month, the company was pleased to announce that they have successfully completed manufacturing the requisite cell bank for their upcoming Phase 1/2a clinical trials in Parkinson’s, having produced in excess of 2.6 billion clinical-grade human neural stem cells, which is more than enough to cover all foreseeable clinical needs, utilizing the company’s patented hpNSC production process. The company’s highly-optimized and chemically-defined differentiation production process was published in a Nature publication in 2013 and ensures that all hpNSCs are manufactured according to strict cGMP-compliant conditions and that these high purity cells are effectively cryopreserved.

This platform and production technology puts ISCO at the forefront of hpSC science today and makes this publicly-traded biotech company a real up-and-comer for investors to keep a close eye on, as their hpSC platform and production architecture’s potential goes well beyond just developing Parkinson’s treatments. The company is also currently developing hpNSCs for ischemic stroke, a leading cause of death in the U.S., which claims over 130k lives each year and which represents over 87% of all stroke cases caused by a clot in a blood vessel that supplies the brain.

Treatment options are very limited for ischemic stroke sufferers and while dissolving the blood clot within two to three hours after the acute phase has shown to be effective, often severe debilitation can occur and extensive rehabilitation is necessary to recover (some, generally not all) cognitive and motor functions. With around 800k cases of stroke each year in the U.S., effectively costing (direct and indirect) over $74 billion, the demand for ISCO’s hpNSC solution is potentially even greater here than it is for Parkinson’s.

With compelling pre-clinical evidence that NSC treatment can actually reverse the debilitation caused by a stroke, even when it is utilized several weeks after the initial acute phase of the stroke, ISCO’s highly purity hpNSC solution could emerge as the de facto treatment option for ischemic strokes and seriously help patients to ably recuperate from an otherwise potentially crippling incident. Looking at the company’s hpNSC clinical development pathway for such CNS issues as Parkinson’s and ischemic stroke, it is pretty easy to see that additional cell therapy treatment options for other CNS diseases and disorders can be developed using this technology.

ISCO is dedicated to developing new treatment options for CNS diseases, as well as those of the liver and eye where such cell therapy has demonstrated efficacy, but where options are currently limited by a lack of readily available, safe human cells. The company’s ability to readily produce high purity stem cell-derived liver cells (CytoHep), as well as human retinal epithelium (RPE) cells and human corneal cells/whole corneal tissue (CytoCor) from human parthenogenetic stem cells, puts their development pipeline potentially within eventual striking distance of treating a vast array of conditions. Conditions like the metabolic liver disease Crigler-Najjar syndrome, which can lead to severe brain and nervous system damage (as well as death), as well as eye conditions like age-related macular degeneration, which causes vision loss and blindness in as many as 50 million people around the world today.

Learn more about the company by visiting www.internationalstemcell.com

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International Stem Cell Corp. (ISCO) Positions Itself to Leverage Parthenogenesis Technology

February 20, 2015

International Stem Cell Corp. uses it core technology, parthenogenesis, to create pluripotent human stem cells from unfertilized eggs. By avoiding the use or destruction of viable human embryos, the company is able to dodge ethical issues while producing billions of human cells that can be used to research various neurological disorders, diseases of the liver and blindness caused by corneal damage.

ISCO recently announced the completion of a massive cell bank containing over 2.6 billion human cells, which will allow the company to conduct clinical trials on Parkinson’s disease in the near future. According to Ruslan Semechkin, ISCO’s Chief Scientific Officer, the completion of the cell bank marks one of the company’s final steps before clinical programs can begin.

The company is able to leverage a tremendous strategic advantage over its competitors by producing cells in its own GMP facility. “Because of the complexity involved in manufacturing live human cell products,” stated Semechkin, “having our own GMP facility is not only a strategic advantage, but also allows us to control the production costs.”

The company’s parthenogenetic stem cells present a multitude of inherent benefits. In addition to being pluripotent, which means that they can potentially turn into any of the body’s cells, they also inherit a duplicate set of human leukocyte antigen (HLA) genes, which can significantly reduce the odds of rejection by patients’ immune systems.

In the past, study of embryonic stem cells has been severely hampered by ethical issues, and significant research has been largely delayed or avoided. However, ISCO’s parthenogenetic cells open the door for research on a variety of diseases and conditions without the need for embryonic growth, which should help to quell ethical concerns.

In addition to its own clinical trials, ISCO also plans to generate revenue by franchising its stem cell technology to multiple cell banks for use in scientific research in a variety of locations. Stem cell research could lead to treatments that save millions of lives and improve overall quality of life for millions more. As ethical hurdles are navigated and research ramps up in the near future, ISCO is strategically positioned to maximize on returns.

For more information, visit www.internationalstemcell.com

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International Stem Cell Corp. (ISCO): A Reckoning Force in the Future of Stem Cell Therapy

February 18, 2015

California biotech International Stem Cell is developing novel stem cell-based therapies and biomedical products geared toward unmet medical needs with limited treatment options. Many such areas already involve clinically proven cell therapy but lack safe human cells. ISCO’s solution to filling these gaps is the company’s patented new class of human stem cells called parthenogenetic stem cells.

ISCO’s core technology, parthenogenesis, enables the creation of pluripotent human stem cells from unfertilized human eggs. These human parthenogenetic stem cells (hpSCs) avoid ethical issue associated with the use or destruction of viable human embryos.

As the world’s first parthenogenetic homozygous stem cell line, ISCO’s hpSCs, which in late 2014 were cleared by the FDA for clinical use, can be immune-matched to millions of people of differing gender, age and racial background.

Using its patented parthenogenesis process, ISCO earlier this month completed the manufacturing of the cell bank of more than 2.6 billion clinical-grade human neural stem cells needed for its upcoming phase 1/2a clinical trial for the treatment of Parkinson’s disease.

In preparation of the clinical study, ISCO formed an Australian subsidiary, Cyto Therapeutics Pty Ltd., designated to manage the regulatory submission to the Australian Therapeutics Goods Administration (TGA) and the up-and-coming clinical study.

Also included in ISCO’s subsidiary portfolio is Lifeline Cell Technology, which manufactures and markets high-quality primary human cells, optimized media and reagents; and Lifeline Skin Care, developer of branded anti-aging skin care products based on growth factors and peptides extracted from hpSCs.

In addition to Parkinson’s disease, ISCO’s scientists are focused on using hpSCs to treat severe diseases of the eye, the nervous system and the liver.

With 220 patents, applications and licenses, a broad pipeline of targets, sturdy balance sheet, and an industry-anticipated clinical trial to launch in mid-2015, ISCO is well-positioned as a reputable innovator in the advance of stem cell-based therapies.

For more information, visit www.internationalstemcell.com

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International Stem Cell Corp. (ISCO) Completes Master Stem Cell Bank in Preparation for Upcoming Parkinson’s Disease Clinical Trial

February 3, 2015

Using its patented process, International Stem Cell has completed the manufacturing of its master cell bank of more than 2.6 billion clinical-grade human neural stem cells. The California biotech company says its existing master cell bank and current production scale are sufficient to meet foreseeable clinical trial requirements, including for the recently announced phase 1/2a clinical trial in Parkinson’s disease.

“Completing the production of clinical-grade cells using the previously published protocol is one of the final steps before starting our clinical program,” Ruslan Semechkin, Ph.D., ISCO’s chief scientific officer, stated in the news release. “Because of the complexity involved in manufacturing live human cell products, having our own GMP (good manufacturing practices) facility is not only a strategic advantage, but also allows us to control the production costs. We continue to anticipate, subject to regulatory agency approval, beginning the clinical trial in early 2015 and will provide a further update in the near future.”

ISCO’s master cell bank of human parthenogenetic neural stem cells (ISC-hpNSC) is produced at the company’s state-of-the art GMP manufacturing facility located in Oceanside, California, and in compliance with current good manufacturing practices (cGMPs) and the chemistry and manufacturing controls (CMC) discussed in the previously reported pre-IND meeting with the FDA.

ISC-hpNSCs are a novel therapeutic cellular product derived from the company’s proprietary human pluripotent stem cells. The cells are karyotypically normal hpNSCs and free of measurable contaminants of human or animal origin. The production of hpNSCs from undifferentiated pluripotent human parthenogenetic stem cells in the master cell bank uses qualified reagents and a standardized protocol developed by ISCO. The undifferentiated human stem cells are derived from the parthenogenetic line and were recently cleared by the FDA for use in clinical trials. Each batch of hpNSC is subjected to standardized quality control testing to ensure viability, sterility and appropriate cellular composition before clinical use.

Neural stem cells are self-renewing multipotent cells that are precursors for the main cell types of the central nervous system. The ability of ISC-hpNSCs to differentiate into dopaminergic neurons and express brain-protecting neurotrophic factors offers a new opportunity for the treatment of Parkinson’s disease. ISCO’s preclinical program includes animal studies to assess the safety and tolerability of its novel cell therapy as well as doses ranging efficacy to be used to design the first clinical trial in Parkinson’s disease patients.

For more information visit www.internationalstemcell.com

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International Stem Cell Corp. (ISCO) Enters Agreement with $1 Billion Global Pharmaceutical Company

July 8, 2014

International Stem Cell Corp., a biotech company developing novel stem cell-based therapies, announced this morning that it has entered into a twelve-month research agreement with Rohto Pharmaceutical Co., Ltd., a global Japanese pharmaceutical company that develops new technology for the medical and cosmetics markets with approximately $1.3 billion in consolidated annual sales. Founded in 1899, Rohto today has products available in more than 150 countries.

Rohto has agreed to evaluate stem cell-derived human cells owned and provided by ISCO in a number of pre-clinical animal models. If the research is successful and the parties agree on remaining terms, it is anticipated that a definitive license agreement will be signed at the end of this research agreement. Certain key terms of such a license agreement, including the target disease areas and intellectual property rights, have already been defined in the research agreement.

“We are delighted to have such an outstanding company work with us, and we believe that the potential for this agreement is significant,” stated Dr. Simon Craw, EVP of Business Development at ISCO. “Under the terms of the agreement Rohto will begin working with our cells immediately and if the program is successful we may move to the next stage, signing a definitive license agreement. Such an agreement would significantly enhance our standing in a number of ways. Firstly, having diligently built up our scientific strength and patent portfolio over the last few years, it would both validate our research as well as our ability to generate licensing revenue from our proprietary platform. Secondly, by expanding the use of our technology into new areas beyond that which we can address alone, it would add value to the Company.”

Under the agreement ISCO will provide a number of differentiated human cells derived from the company’s collection of pluripotent human stem cells known as UniStemCell™. The Company has a track record of successfully demonstrating that human cells derived from UniStemCell™ are effective in animal models of various diseases and have the potential to be used as a basis for developing human therapies. ISCO has adopted this approach successfully with a number of academic collaborators in the past.

For more information on International Stem Cell Corp., please visit www.internationalstemcell.com

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