Category Archives: International Stem Cell Corp. ISCO

International Stem Cell Corporation (ISCO) Continues Upward Climb toward Changing the Face of Regenerative Medicine

February 2, 2016

A California-based biotechnology company, International Stem Cell Corporation (OTCQB: ISCO) focuses its energies on developing restorative medicine using stem cell technology. Its innovative parthenogenesis technology uses human stem cells derived from unfertilized oocytes (eggs), which helps the company avoid any ethical issues involving the destruction of viable human embryos. ISCO also produces and markets cells and growth media for therapeutic research worldwide through its subsidiary, Lifeline Cell Technology. For even more revenue, the company’s other subsidiary, Lifeline Skin Care, markets and sells a skin care line that promises rejuvenation and beauty.

In December, Lifeline Skin Care launched its Molecular Renewal Serum™, just in time for the holidays. This product contains an impressive nano-compound that works with skin to replenish elasticity and smoothness. During testing, the serum showed improvement in skin’s resilience and a decrease in roughness without any negative side effects. The serum also stimulates collagen production, which lends strength to skin by regrowing dead skin cells.

That same month, ISCO announced that it had entered a master clinical research agreement with Florey Institute of Neuroscience and Mental Health, one of the world’s leading brain research centers. The agreement cleared the way for scientists to conduct a Phase I/IIa clinical trial studying the effects of human parthenogenetic stem cells in people with Parkinson’s disease. Patients are to be enrolled during the first quarter of 2016.

ISCO’s groundbreaking stem cells are created by stimulating oocytes into dividing themselves into histocompatible cells. The company strives to create immune matching cells, so that people do not reject the treatment. So far, ISCO scientists have developed the first line of stem cells that can be used as therapeutic cells for millions of people with minimal rejection. The company also aligns itself with the UniStemCell Bank, the first collection of non-embryonic stem cells, in the hopes of increasing widespread use and scientific breakthroughs.

With the steady financial growth of ISCO and its subsidiaries, the company hopes to continue making great strides in regenerative techniques for eye, liver, and nervous system diseases.

For more information, visit www.internationalstemcell.com

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International Stem Cell Corporation (ISCO) Teaming with Leading Brain Research Center to Advance Development of Powerful Stem Cell Technology

January 28, 2016

International Stem Cell Corporation (OTCQB: ISCO) is the company behind a powerful new stem cell technology called parthenogenesis, which promises to significantly advance the field of regenerative medicine by addressing the problem of immune-rejection. Derived from unfertilized eggs, the company’s human parthenogenetic stem cells (hPSCs) are pluripotent, meaning that they have the potential to become virtually any cell in the human body.

The first pluripotent stem cells to be studied for the purposes of regenerative medicine were embryonic stem cells (ESCs), which were taken from donated human embryos. While these cells could offer considerable healing potential, they also present a number of ethical concerns, because their production involves the destruction of a human embryo. ISCO’s hPSCs avoid these ethical issues while retaining many of the inherent advantages of ESCs.

One of the key factors limiting the advancement of regenerative medicine in the past has been the issue of immune-rejection. ESCs, much like transplanted organs, come with a high probability of rejection. This means that, after injection, the host’s immune system attacks the stem cells in an effort to prevent infection. When unfertilized human eggs undergo parthenogenesis, however, they inherit a duplicate set of human leukocyte antigen (HLA) genes, which greatly decrease the risk of immune-rejection. According to the company’s preclinical data, a relatively small number of hPSCs could be sufficient to provide ‘immune matched’ cells to a large percentage of the global population.

ISCO’s developmental pipeline includes a collection of hPSC-based treatments targeting severe diseases of the central nervous system, the liver and the eye. The company’s most advanced product candidate is for the treatment of Parkinson’s disease, which affects an estimated 10 million people worldwide and as many as one million in the United States alone. In preclinical studies, rodent and non-human primate subjects have shown measurable improvement in Parkinson’s disease symptoms and an increase in brain dopamine levels following the intracranial administration of hPSCs.

Last month, ISCO announced that it had entered into a master clinical research agreement with the Florey Institute of Neuroscience and Mental Health of Australia, one of the world’s leading brain research centers, to conduct a phase I/IIa clinical trial of hPSCs in Parkinson’s disease patients. Under the terms of this agreement, ISCO will work with the Florey to conduct these studies at the Royal Melbourne Hospital.

“We recently received authorization to initiate Phase I/IIa and now we are moving forward toward formal engagement of the clinical site to conduct this study,” Russell Kern, PhD, executive vice president and chief scientific officer at ISCO, stated in a news release. “We expect to enroll all patients into the clinical trial in Q1 2016 and provide interim results in October 2016.”

For more information, visit www.internationalstemcell.com

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International Stem Cell Corp. (ISCO) Developing Therapeutic Products from Its Own Intellectual Property

January 20, 2016

As part of its quest to successfully develop stem cells for research and therapy, the International Stem Cell Corporation (OTCQB: ISCO) has been using a powerful new stem cell technology to address the problem of immune-rejection. Most recently, the Carlsbad, California-based company has been focused on utilizing parthenogenesis to advance the field of regenerative medicine.

Parthenogenesis is a process that uses unfertilized human eggs to create a new class of pluripotent human stem cells. These stem cells, known as human parthenogenetic stem cells (hpSCs), are specialized because they can be immune-matched to millions of people, and a small number of hpSC lines alone can provide enough immune-matched cells for a large fraction of the world’s population. HpSCs also have the added benefit of retaining many of the advantages usually linked to embryonic stem cells while circumventing the ethical issues.

By relying on its novel business model consisting of a number of revenue-generating subsidiaries, including Lifeline Cell Technology and Lifeline Skin Care, ISCO has been developing therapeutic products from its own intellectual property for years.

Thanks to the creation of the UniStemCell bank, the foundation of ISCO’s research and the globe’s greatest collection of non-embryonic histocompatible human stem cells used for research and commercial use, ISCO has been able to innovate in the area of therapeutics. The company, which is committed to developing stem cell treatments for neurological disorders, liver diseases and blindness caused by corneal damage, has been able to focus its hpSCs research efforts on treating these diseases and disorders, especially in areas where cellular replacement has been shown to be effective clinically, but there is a limited or no viable source of safe, ethical cells to treat patients.

At the same time, Lifeline Skin Care, a wholly-owned ISCO subsidiary and cosmeceutical business, has been developing, manufacturing and marketing cosmetic skin care products using a proprietary extract derived from the company’s pluripotent stem cells. Lifeline Cell Technology, another wholly-owned subsidiary and research products business, has also been creating, manufacturing and marketing human cell culture products, including frozen human “primary” cells and the reagents (media) needed to grow, maintain and differentiate the cells.

So not only has ISCO’s research and development team been using its hpSCs to make important breakthroughs in the treatment of a number of serious diseases, the company has also developed two successful business units which generate revenues from the sale of products that employ ISCO’s scientific discoveries.

For more information, visit www.internationalstemcell.com

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International Stem Cell Corporation (ISCO) – Florey Clinical Service Agreement Expected to Deliver Results Later this Year

January 13, 2016

International Stem Cell Corporation (OTCQB: ISCO), a clinical stage biotechnology company developing novel stem cell-based therapies, recently announced that it has entered into an agreement with the Florey Institute of Neuroscience and Mental Health (Florey) to conduct a Phase I/IIa clinical trial, dose escalation trial of human parthenogenetic stem cells-derived neural stem cells (ISC-hpNSC) in Parkinson’s patients. The Florey is viewed by the medical community as one of the world’s leading brain research centers. With the largest neuroscience research team in Australia at its side, both parties’ collaborative efforts are now underway.

Director of the Movement Disorders Service at the Royal Melbourne Hospital, Dr. Andrew Evans, M.D., has assumed the duties that come with being named the study’s principal investigator. Dr. Evans has published extensively on Parkinson’s, addressing symptoms while leading several clinical research trials.

“We recently received authorization to initiate Phase I/IIa and now we are moving forward towards formal engagement of the clinical site to conduct this study. We are excited to work together with the Florey to conduct the clinical trials of ISC-hpNSC at the Royal Melbourne Hospital,” commented Russell Kern, PhD, executive vice president and chief scientific officer at International Stem Cell Corporation. “We expect to enroll all patients into the clinical trial in Q1 2016 and provide interim results in October 2016.”

ISC-hpNSC consists of a highly pure population of neural stem cells derived from human parthenogenetic stem cells. ISC-hpNSC are a suspension of clinical grade cells manufactured under cGMP conditions that have undergone stringent quality control measures and are clear of any microbial and viral contaminants.

ISCO’s resources and efforts are aimed at therapeutic applications of human parthenogenetic stem cells (hpSCs) and the development and commercialization of cell-based research and cosmetic products. Parthenogenesis, ISCO’s core technology, results in the creation of pluripotent human stem cells from unfertilized oocytes. hpSCs avoid ethical issues associated with the use or destruction of viable human embryos. Company scientists have created the first parthenogenetic, homozygous stem cell line that can be a source of therapeutic cells for hundreds of millions of individuals of various genders, ages and racial backgrounds with minimal immune rejection after transplantation.

For more information, visit www.internationalstemcell.com

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International Stem Cell Corporation (ISCO) may be Running a Loss, but it’s also Making a Profit

January 11, 2016

International Stem Cell Corporation (OTCQB: ISCO) has its fingers in many pies. It develops and markets products in three different lines, and two of those businesses turn a profit. Its biomedical division is the most profitable. For the nine months ending September 30, 2015, the net operating profit on biomedics was $920,000 on sales of $2,925,000, a healthy return on sales (ROS) of 31%. ROS measures a company’s operational efficiency, and ISCO’s ROS shows it’s getting better at what it does. Its ROS for 2015 was a vast improvement on the comparable period in 2014, when ROS for the biomedics division was 23%. For the nine months to September 30, 2014, ISCO’s biomedics division had net income of $616,000 on revenues of $2,681,000. ISCO’s biomedics business tells a happy story all around. Sales in 2015 improved by 9% over 2014 sales while operating costs fell by 3%, and net operating profit for 2015 in biomedics rose an astonishing 49% over the comparable period in 2014.

The cheerful news extends to ISCO’s cosmetics division. Sales in cosmetics for 2015 were $2,648,000, five percent over 2014 sales of $2,519,000. Net operating profit, or ROS, on cosmetics almost tripled, going from 4% in 2014 to 11% in 2015. Once again, ISCO has managed to cut costs and increase revenues. Costs in 2015 for cosmetics fell by 2%. The cosmetics division generated a net income of $287,000, which represents a whopping 163% increase in net income over the similar period in 2014.

Together, these two profitable enterprises have increased ISCO’s 2015 bottom line by $482,000, a nice 66% increase over 2014. Using a very conservative price to sales ratio of 10 would value ISCO’s biomedics and cosmetics divisions together at about $56 million.

However, ISCO is not resting on its laurels. The company is plowing ahead with its innovative line of therapeutics based on a potent new stem cell technology that employs parthenogenesis. Parthenogenesis is a type of reproduction that takes place in the absence of fertilization. The company’s new stem cell technology holds the promise of advancing significantly the field of regenerative medicine by addressing the problem of immune-rejection. Stem cells are able to divide in a process of self-renewal in which one cell gives birth to two or more. They are also able to differentiate into cells of a different type so that a stem cell originating from one part of the body may differentiate into a type that is similar to the cells in another part of the body.

At the top of ISCO’s list is Parkinson’s disease. Parkinson’s is characterized by noticeable tremors of the hands. The Parkinson’s Disease Foundation estimates that approximately 60,000 Americans are diagnosed with Parkinson’s disease each year, a number that may not reflect the thousands of cases that go undetected. About one million Americans live with the disease, and an estimated seven to ten million people worldwide are living with Parkinson’s disease. ISCO’s UniStemCell for Parkinson’s has completed the Food & Drug Administration (FDA)’s Investigational New Drug (IND) phase, which means it will soon begin clinical trials. Clinical trials occur when the effects of new treatments on humans are studied.

International Stem Cell Corporation is a company with a bright future. It has two money-making divisions that continue to show increasing profitability. There’s little doubt that its foray into therapeutics will be equally successful.

For more information, visit www.internationalstemcell.com

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International Stem Cell Corp. (ISCO) Edges Ever Closer to First Real Therapeutic Solution for Halting & Even Reversing Parkinson’s

December 28, 2015

With the recent announcement from Australia’s version of the FDA, the Therapeutic Goods Administration, that pluripotent stem cell manufacturing innovator International Stem Cell Corp. (OTCQB: ISCO) has been cleared to start Phase I/IIa dose escalation clinical trials focused on the safety and efficacy of its human parthenogenetic neural stem cells (ISC-hpNSCs), the company has taken another major step toward a real therapeutic solution to Parkinson’s disease. An incurable condition that primarily affects the planet’s growing elderly population, Parkinson’s currently afflicts well over 10 million people worldwide and represents a therapeutics market somewhere in the neighborhood of $2.6 billion.

However, while the sale of extant therapeutics will continue to be dominated by mere dopamine agonists and an increasing use of MAO-B inhibitors (historically used to treat depression), such treatments are palliative at best, and sales will be substantially impacted by the rapid proliferation of generics. Even the newer agents coming down the industry’s pipeline through to 2020, such as a reformulated levodopa from Impax Laboratories (NASDAQ: IPXL) and GlaxoSmithKline (NYSE: GSK), or the MAO-B inhibitor safinamide being developed by Merck (NYSE: MRK), Newron (OTC: NWPHF) and EMD Serono, will be forced to compete with generics.

ISCO, on the other hand, has the inside track in this market with an injectable cellular therapy that is potentially capable of actually replacing dead and dying neurons in the midbrain, while directly offsetting Parkinson’s symptoms. This solution also offers substantial protection to surviving neurons, shielding them from further deterioration. Considerable pre-clinical animal model testing has already shown extremely promising results and the progress ISCO is set to make via the Phase I/IIa clinical trial in humans could propel the company to stardom as the first to develop an actual solution for Parkinson’s sufferers.

This same technology, because it employs high purity functional adult human cells that have been created from unfertilized donor eggs at the company’s state-of-the-art Oceanside, California, facility using an ethical, patented chemical differentiation process, could also evolve into frontline treatments for other CNS (central nervous system) maladies such as Alzheimer’s and stroke. The FDA’s recent IND approval of Stemedica’s allogeneic (same species but genetically dissimilar and generally immunologically incompatible) stem-cell therapy for a Phase IIa clinical study in Alzheimer’s at UC San Diego shows how much potential there is for this kind of technology, and how receptive the FDA has become to stem cell technology.

ISCO’s ability to manufacture commercial-scale batches of both precisely human leukocyte antigen-matched (HLA) and therefore histocompatible human parthenogenetic stem cell lines, as well as HLA-homozygous lines that are suitable for significant segments of the overall population, gives the company a real edge here as well. Stemedica’s allogeneic stem cells, for instance and by contrast, are cultivated from donor tissues, not differentiated from unfertilized eggs. Thus, ISCO’s technology is quite remarkable, because it substantially overcomes one of the main challenges facing stem cell therapeutics as a viable solution to numerous diseases; namely, cell rejection by the patient’s immune system.

International Stem Cell Corporation could be first to market a treatment actually capable of halting the progression of Parkinson’s disease in its tracks, or even reversing the impact of the disease. Results from the company’s landmark human clinical trial should start to become available in the coming months and investors should keep a close eye on ISCO for breaking news.

For more information, visit www.internationalstemcell.com

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International Stem Cell Corp. (ISCO) to Conduct Clinical Trial with One of the World’s Leading Brain Research Centers

December 23, 2015

International Stem Cell Corp., a clinical stage biotech company developing novel stem cell-based therapies, has signed a master clinical research agreement with the Florey Institute of Neuroscience and Mental Health to conduct phase I/IIa clinical trial, dose escalation trial of human parthenogenetic stem cells-derived neural stem cells (ISC-hpNSC) in Parkinson’s disease (PD) patients. ISCO said it expects to enroll all patients into the clinical trial in the first quarter of 2016, with interim results available in October.

ISCO is well-paired with the Florey Institute, which is staffed with the largest neuroscience research team in Australia and ranked as one of the world’s leading brain research centers. Also participating in the clinical study is Dr. Andrew Evans, M.D., director of the Movement Disorders Service at the Royal Melbourne Hospital, who will be the study’s principal investigator. Dr. Evans heads numerous clinical research trials, and has extensively published on PD, particularly addressing symptoms that impact on the quality of life of sufferers. He is also a member of the Melbourne Health Ethics Committee.

“We recently received authorization to initiate phase I/IIa and now we are moving forward towards formal engagement of the clinical site to conduct this study. We are excited to work together with the Florey to conduct the clinical trials of ISC-hpNSC at the Royal Melbourne Hospital,” Russell Kern, PhD, executive vice president and chief scientific officer of ISCO, stated in the news release.

ISC-hpNSC consists of a highly pure population of neural stem cells derived from human parthenogenetic stem cells. Preclinical studies in rodents and non-human primates have shown improvement in PD symptoms and increase in brain dopamine levels following the intracranial administration of ISC-hpNSC. ISC-hpNSC are safe, well-tolerated and do not cause adverse events such as dyskinesia, systemic toxicity or tumors in preclinical models.

ISCO is also exploring ISC-hpNSC’s potential in broad therapeutic applications for many neurological diseases affecting the brain, the spinal cord and the eye.

For more information, visit www.internationalstemcell.com

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International Stem Cell Corporation’s (ISCO) Clinical Trials Vital to Halting Progression of Parkinson’s Disease

December 17, 2015

Parkinson’s disease is a progressive movement disorder, meaning that symptoms continue to get worse over time. Approximately one million people in the US are living with this disease. While there is currently no cure and its cause remains unknown, treatment options for managing symptoms range from medication to surgery.

Parkinson’s (PD) involves the death of nerve cells in the brain, called neurons. Some of these dying neurons produce dopamine, a chemical that sends messages to the part of the brain that controls movement and coordination. As PD progresses, the amount of dopamine produced in the brain decreases. The result is that the inflicted individual is unable to control movement in a normal fashion.

Scientists are also exploring the suggestion that loss of cells in other areas of the brain and body contribute to PD. As an example, researchers have discovered that the first indication of PD — clumps of a protein alpha-synuclein, which are also called Lewy bodies — is found not only in the mid-brain, but also in the brain stem and the olfactory bulb. These areas of the brain are associated with non-motor functions such as sense of smell and sleep regulation. Scientists believe that the presence of Lewy bodies in these areas could explain the non-motor symptoms experienced by some people with PD before any motor sign of the disease appears.

Central to the conversation of the treatment of PD is International Stem Cell Corporation (OTC: ISCO). The company’s wholly owned subsidiary, Cyto Therapeutics, has received regulatory approval by the Therapeutics Goods Administration (TGA) of Australia to initiate a phase I/IIa dose escalation trial of human parthenogenetic stem cells-derived neural stem cells (ISC-hpNSC) in patients with moderate to severe PD.

In 2014, the company announced encouraging results from preclinical studies of its ISC-hpNSC therapeutic candidate. In its preclinical studies, the cells demonstrated an improvement in PD symptoms and promoted increases in brain dopamine levels following the intracranial administration of ISC-hpNSC. The studies also noted that the ISC-hpNSCs provided neurotrophic support and cell replacement to dying dopaminergic neurons.

International Stem Cell Corporation is a publicly traded biotechnology company with a powerful new stem cell technology called parthenogenesis, which uses unfertilized eggs and promises to significantly advance the field of regenerative medicine by addressing the problem of immune-rejection. The company is centered on using stem cells to treat diseases of the eye, the nervous system and the liver, where cell therapy has been proven clinically but is limited by the availability of safe immune-matched human cells or tissue.

For more information, visit www.internationalstemcell.com

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International Stem Cell Corp. (ISCO) Gets Regulatory Green Light to Begin Clinical Trial of ISC-hpNSC for the Treatment of Parkinson’s Disease

December 14, 2015

Currently available Parkinson’s disease treatments, while capable of improving the early symptoms of the disease, lose their effect as the disease progresses and produce involuntary writing movements in the patients. As of yet there is no cure for the disease, which is the second most common neurodegenerative disease and affects over 7 million people worldwide. International Stem Cell Corp. (OTC: ISCO), a leader in using pluripotent stem cells in regenerative medicine, this morning issued news regarding its stem cell technology – signaling a potential blockbuster shift it the treatment of Parkinson’s disease.

ISCO today announces that its wholly owned subsidiary, Cyto Therapeutics, has received regulatory approval by the Therapeutics Goods Administration (TGA) of Australia to initiate a phase I/IIa clinical trial, dose escalation trial of human parthenogenetic stem cells-derived neural stem cells (ISC-hpNSC) in patients with moderate to severe Parkinson’s disease.

“We are very pleased to start the first human study of ISC-hpNSC’s for the treatment of this debilitating disease. There is a large unmet medical need for new treatments that may halt or reverse the progression of Parkinson’s disease and we believe our human neural stem cells may fill this need for the millions of people with this disease” stated Andrey Semechkin, PhD, ISCO’s chief executive officer. “We look forward to reporting on the progress of the clinical trial over the coming months.”

ISCO last year announced positive results from its preclinical studies for its ISC-hpNSC therapeutic candidate. In those preclinical studies, the cells demonstrated an improvement in Parkinson’s disease symptoms and increase in brain dopamine levels following the intracranial administration of ISC-hpNSC. The studies further noted that the ISC-hpNSCs provided neurotrophic support and cell replacement to dying dopaminergic neurons.

About the clinical study

The upcoming phase I/IIa clinical study – which will be performed at Royal Melbourne Hospital in Melbourne, Australia – is a dose escalation safety and preliminary efficacy study of human parthenogenetic stem cells-derived neural stem cells (ISC-hpNSC) intracranially transplanted into patients with moderate to severe Parkinson’s disease. The open-label, single center, uncontrolled clinical trial will evaluate three different dose regimens of 30 million-70 million neural cells. A total of 12 participants with moderate to severe Parkinson’s disease will be treated. Following transplantation, the patients will be monitored for 12 months at specified intervals, to evaluate the safety and biologic activity of ISC-hpNSC.

“We are the first company in the world to conduct clinical trials of human pluripotent stem cells based product for the treatment of Parkinson’s disease. We believe the outcome of the study will produce findings in-line with our preclinical studies, where we demonstrated not only safety of our proprietary neural stem cells, but also their functional efficacy. The cells were able to successfully integrate into the brain and provide a significant increase of dopamine levels in the nigrostriatal system” commented Russell Kern, PhD, ISCO’s executive vice president and chief scientific officer.

For more information, visit www.internationalstemcell.com

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International Stem Cell Corp. (ISCO) Has a Broad Pipeline of Targets

December 8, 2015

International Stem Cell Corp. is tackling some of the world’s most debilitating health maladies with a powerful new stem cell technology that employs parthenogenesis. Parthenogenesis is a type of reproduction that takes place in the absence of fertilization. The company’s new stem cell technology holds the promise of advancing significantly the field of regenerative medicine by addressing the problem of immune-rejection. Stem cells are able to divide in a process of self-renewal in which one cell gives birth to two or more. They are also able to differentiate into cells of a different type so that a stem cell originating from one part of the body may differentiate into a type that is similar to the cells in another part of the body.

At the top of ISCO’s list is Parkinson’s disease. Parkinson’s is characterized by noticeable tremors of the hands. But since it is a progressive disorder of the nervous system that affects motor functions, it also commonly causes stiffness or slowing of movement. The Parkinson’s Disease Foundation estimates that approximately 60,000 Americans are diagnosed with Parkinson’s disease each year, a number that may not reflect the thousands of cases that go undetected. About one million Americans live with the disease and an estimated seven to ten million people worldwide are living with Parkinson’s disease. ISCO’s UniStemCell for Parkinson’s has completed the Food & Drug Administration (FDA)’s Investigational New Drug (IND) phase, which means it will soon begin to undergoing clinical trials. Clinical trials occur when the effects of new treatments on humans are studied.

ISCO’s development of neural stem cells for the treatment of ischemic strokes is also at an advanced stage. Pre-clinical trials have been completed, and the company is now embarking on the FDA’s IND phase. Ischemic strokes occur as a result of an obstruction within a blood vessel supplying blood to the brain. The Centers for Disease Control and Prevention (CDC) estimate that, on average, one American dies from stroke every four minutes and that more than 795,000 people in the United States have a stroke each year. About 87% of all strokes are ischemic strokes.

ISCO is also developing treatments for spinal cord injury, metabolic liver diseases, retinal blindness and corneal blindness. These four treatments are all at the pre-clinical stage. Metabolic liver diseases, retinal blindness, corneal blindness and spinal cord injuries are ailments that affect hundreds of thousands. The National Spinal Cord Injury Statistical Center at the University of Alabama at Birmingham estimates that between 240,000 and 337,000 people in the United States are currently living with spinal cord injuries (SCI) and 12,500 new SCI cases occur every year.

So far ISCO has accepted no government subventions and has been able to generate income from its two subsidiaries to help fund its research. One subsidiary, Lifeline Skin Care, Inc., develops, produces, and markets a line of anti-aging cosmetic skin care products. The other is Lifeline Cell Technology, LLC, which develops, manufactures, and sells human cell culture products along with optimized reagents for laboratory research purposes. For the many sufferers of Parkinson’s disease and other debilitating conditions, relief from ISCO is on the way.

For more information, visit www.internationalstemcell.com and www.lifelineskincare.com

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International Stem Cell Corp. (ISCO) to Launch New, Highly Lauded Skincare Product this Holiday Season

December 1, 2015

International Stem Cell Corp., a California-based biotech developing novel stem cell-based therapies and biomedical products, reports that its Lifeline Skin Care, Inc. subsidiary will launch its next generation skin care product in time for this year’s retail holiday season, which according to research from eMarketer will grow nearly 6% this year.

Starting in mid-December, U.S.-based consumers can purchase Molecular Renewal Serum™ through Lifeline’s website at www.lifelineskincare.com. Following product launches will target the domestic professional sales market such as luxury spas, aestheticians, and medical offices, as well as luxury skincare markets in Europe and Asia.

Molecular Renewal Serum is a collaboration between ISCO’s research and development team, which developed the breakthrough nano-compound technology behind the product, and a renowned cosmetic chemist who formulated the serum.

Independent third-party testing demonstrated that the new skin care product significantly improves skin elasticity and decreases skin roughness in all subjects four and eight weeks after the start of the study. Additionally, the compound-treated group outperformed the baseline as well as the Retinol treated group, without adverse events, such as skin irritation, which has been reported as a common side effect of Retinol treatment.

Lifeline’s current product line includes the Daily Defensive Complex, Recovery Night Moisture Serum, Eye Firming Complex, Dual Action Exfoliator, and Brightening Cleanser. In addition to the Molecular Renewal Serum, in 2015 Lifeline introduced two new products — Refresh Polishing Gelée and Neck Firming Complex.

ISCO’s confidence in Lifeline’s products is validated by professionals in the skin care industry.

Dr. Steven F. Weiner, MD, a facial plastic surgeon and pioneer in the field of minimally invasive cosmetic procedures, stated, “Our office has been using Lifeline Stem Cell Skin products for about four years. We have used it on freshly lasered and microneedled skin without complications and with improved healing times. All of our Infini patients have Lifeline applied and most continue to use it well after treatment because of the noted skin improvements it provides. It’s our best-selling growth factor product because of its higher concentrations of growth factors, streamlined product line and superior results.”

Jill Haynes, a Medical Aesthetician working under Jonathan Sykes, MD, a world renowned pioneer in facial plastic and reconstructive surgery research, at the University of California, Davis Medical Center recommends micro-needling treatments along with Lifeline Skincare products to her patients. “I am seeing incredible results in my patients. This is the biggest skin care breakthrough in years,” she says. “It’s not just about one product or procedure; it’s about using the best products and procedures in conjunction to create noticeable change in the skin.”

Lifeline has established a distribution network with global reach. Products are distributed domestically through the company’s branded website and network of dermatologists, plastic surgeons, and spas. On an international scale, Lifeline products are distributed through a network of local distributors. Shuei Trading Company, Lifeline’s largest international distributor, has introduced currently offered and custom-developed Lifeline products to the Japanese and Hong Kong markets.

Backed by a solid distribution network and growing family of breakthrough products, Lifeline has enjoyed rapid brand and product awareness since its inception five years ago, resulting in steady sales growth and operating income. So far this year, Lifeline has notched $2.6 million in revenue and remains on pace to achieve continued annual growth. Third-quarter revenues equaled $924,000, and the company forecasts even higher fourth-quarter sales.

In 2016, Lifeline plans to continue its upward growth trend with the introduction of several new products based on its proprietary extract and nano-compound technologies.

For more information, visit www.internationalstemcell.com and www.lifelineskincare.com

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International Stem Cell Corporation (ISCO) Uses Multiple Business Units to Generate Even More Revenue

November 30, 2015

International Stem Cell Corporation (OTC: ISCO) focuses on utilizing patented human parthenogenetic stem cells (hPSC), developed from unfertilized embryos, to treat Parkinson’s, retinal, and liver diseases where replacing dead and dying cells with new ones seems most effective. However, the road to commercialization and FDA approval is a long one. Therefore, the company has two wholly-owned subsidiaries that generate money in the meantime: Lifeline Skin Care, Inc. and Lifeline Cell Technology, LLC.

The first, Lifeline Skin Care, Inc., develops, produces, and markets a line of anti-aging cosmetic skin care products. These products use the company’s scientific rejuvenation breakthrough of non-embryonic stem cells to improve the look and feel of skin. These products include neck and eye firming creams, moisturizers, cleansers, and more. Sold all over the world, this cosmetic line promises youthful and healthy looking skin.

The second, Lifeline Cell Technology, LLC, develops, manufactures, and sells human cell culture products along with optimized reagents for laboratory research purposes. For example, the company offers VascuLife®SMC, a human smooth muscle cell medium optimized for the culture of human smooth muscle cells. This provides 15 population doublings at high growth rates. The company also sells Normal Human Mammary Epithelial Cells (HMEC) that provide a serum-free culture model for research on breast cancer, carcinogen screening, and other areas of breast research. All of Lifeline Cell Technology products are rigorously tested to the highest degree for maximum laboratory research operations.

In a news release, Andrey Semechkin, Ph.D., CEO, and co-chairman of ISCO recently stated, “We are maintaining our position as a leader in the regenerative medicine field and the overall operating income of our biomedical businesses continues to grow.” The company continues to manufacture and market its proprietary innovations while advancing developments in treatments of various diseases using stem cells.

To find out what the buzz is all about, visit www.internationalstemcell.com

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International Stem Cell Corp. (ISCO) Injection of Ethically-Derived Neural Stem Cells for the Treatment of Parkinson’s to Be Tested in Australia

November 23, 2015

The true forefront in medicine today is a broad offensive where medical and research professionals are now pulling out all the stops in a never-ending war against broad-spectrum degenerative diseases like cancer or degenerative diseases of specific tissues, such as Parkinson’s and Alzheimer’s, which severely cripple a patient’s central nervous system (CNS). Unfortunately, there is very little in the way of truly therapeutic options for patients with degenerative CNS diseases.

In the case of Parkinson’s, dopamine-generating neurons in the midbrain (substantia nigra) progressively die off, resulting in a variety of motor control issues (dyskinesia) at first, with dementia, insomnia, and severe depression or emotional problems typically following in later stages. There is no currently known cure for Parkinson’s and the standard of care consists primarily of medications designed to manage and/or provide relief from the symptoms.

The main family of drugs used to offset Parkinson’s symptoms is Levodopa (L DOPA, which metabolizes into dopamine), but MAOIs (monoamine oxidase inhibitors) and dopamine agonists have seen a significant increase of use in recent years as a first choice, in order to prolong the start of L DOPA treatment. For you see, prolonged use of L DOPA typically results in dyskinesia that is equivalent to the long-term effects of Parkinson’s itself.

Because less than 10 percent of L-DOPA actually makes it through the blood-brain barrier, the vast majority of it is metabolized elsewhere in the body, resulting in numerous side effects like nausea and joint stiffness, in addition to the aforementioned Parkinson’s-like motor control problems. MAOIs, historically already in wide usage as a treatment for atypical depression, are pretty effective at delimiting the primary monoamine oxidase that degrades dopamine, MAO-B, and thus are able to somewhat offset the lack of dopamine that is being caused by neuronal loss.

As you can see, the only solutions for Parkinson’s patients which are currently available aren’t really solutions at all, and carry with them the looming inevitability of a lost battle against this degenerative disease. A truly disheartening reality for patients and their families. Long-term options for Parkinson’s patients and their families are severely limited as well and include invasive surgery, or palliative care designed merely to improve quality for end of life patients. Reasonable extrapolations from official Parkinson’s Disease Foundation data indicates that the number of people on earth currently suffering from the disease is likely close to, or over 10 million. Some 60,000 or more people in the U.S. alone are diagnosed with Parkinson’s each year, meaning the real number is likely much higher, after factoring in all the cases that go undiagnosed, and unreported.

Hence the undisputable potential value of the proprietary, scalable and ethical human parthenogenetic (asexual reproduction from unfertilized egg) stem cell (hpSC) technology currently being developed by International Stem Cell Corp. (OTCQB: ISCO). Because hpSCs are self-renewing multipotent cells, they represent an as-yet essentially untapped goldmine of therapeutic developments which could provide solutions for countless degenerative diseases, and do so across multiple tissue types. The company’s hpSC platform for chemically stimulating eggs to reproduce, which uses a series of different activation techniques in order to create sizeable batches of healthy adult cells that are HLA/immune-matched (human leukocyte antigen) either to the individual or to the general population, has led to an exciting novel therapeutic cellular product consisting of human parthenogenetic neural stem cells (hPNSCs).

Because hPNSCs have been shown to be able to actually differentiate into dopaminergic neurons, therapy using these injected cells represents a wholly-new approach to the problem of Parkinson’s, wherein the root cause of the disease is addressed directly. Moreover, transplanted hPNSCs have been shown to express powerful brain-protecting neurotrophic factors in pre-clinical animal model studies, meaning that not only does this product hold the potential to simply grow new dopamine-producing cells, it can also help shield the remaining healthy cells from degeneration and/or death. ISCO’s recent announcement that the company is now moving full steam ahead towards phase I/IIa human clinical trials in Australia, subsequent to a meeting with the Australian Therapeutics Goods Administration and signage of an LOI with the conducting facility, Royal Melbourne Hospital, is a major milestone for the company. A milestone that puts ISCO squarely in the pole position for developing the first true Parkinson’s therapy.

TGA approval for the phase I/IIa clinical trials is expected sometime this month, with enrollment commencing shortly after, and ISCO could have a real winner on its hands depending on whether the results jog with those generated by the preceding nine-month safety GLP study of 300 rodents, which showed zero tumor growth in any of the subjects receiving transplanted cells. ISCO seems to have overcome the two major stumbling blocks that have hindered other developers in this field: immune-related tissue rejection and tumor formation.

The chemically close-to-nature methodology whereby the company generates its hpSCs is likely a main reason its therapies have had such preclinical successes, and one need look no further than the results for the other candidates (such as those for metabolic liver and degenerative eye diseases) in ISCO’s therapeutic pipeline in order to get a good idea of where the Parkinson’s therapy is headed. A savvy observer will note that the probability of success for ISCO with its hPNSC phase I/IIa clinical trials is telegraphed readily by the demonstrated versatility of the platform in allowing for a robust pipeline of several promising indications. The hpSC platform looks solid and ISCO could have one or two disruptive commercial breakthroughs on its hands in the near future.

Unlike many preclinical biopharma developers, ISCO has a cash pipeline already in place to help fund the expensive work of drug trials, with two wholly-owned subsidiaries that benefit from the company’s hpSC platform: Lifeline Cell Technology and Lifeline Skin Care. Respectively engaged in the sale of human cell culture products/reagents, as well as cosmeceuticals based on a proprietary extract derived from hpSCs, these two profitable subsidiaries not only help feed the R&D machine that is ISCO, they represent promising long-term opportunities in and of themselves. Quarterly financial data out as of November 16 from ISCO shows that Lifeline Cell Technology sales were up handsomely in Q3 (ended September 30), climbing 22 percent compared to the same quarter last year, alongside a nine percent jump in the company’s total consolidated revenue over the same period. Having wound down its multiple preclinical studies during the first six months of 2015, ISCO has managed to slash its cash burn rate and the company is now eager to see the fruits of its labor emerge from human clinical trials of hPNSCs in Parkinson’s.

The ability to grow functional, immune-matched adult human stem cells without the need to fertilize an egg is as ground-breaking a revolution in medicine as it sounds. And ISCO is basically the tip of the spear here too, alongside a tiny handful of other companies, many of whom lack the crucial IP and pre-clinical success story to deliver on a platform solution that could eventually hit hard and fast across the gamut of degenerative and similar diseases.

To find out what the buzz is all about, visit www.internationalstemcell.com

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International Stem Cell Corp. (ISCO) Posts Key Business Highlights, Opens its Books for Q3, YtD 2015

November 16, 2015

International Stem Cell Corp. this morning posted a business update along with operating results for the three- and nine-month periods ended September 30, 2105. Among other results, the California-based biotech company reported an increase in quarterly revenues, along with significantly narrowed third-quarter and nine-month losses.

“Overall I am satisfied with the company’s progress in Q3. We are maintaining our position as a leader in regenerative medicine field and the overall operating income of our biomedical businesses continues to grow,” Andrey Semechkin, Ph.D., CEO and co-chairman of ISCO, stated in the news release. “We really look forward to beginning the enrolment of patients in our pending Parkinson’s disease clinical trial before the end of 2015.”

Q3 Business Highlights

Among several quarterly business highlights, ISCO in the third quarter of 2015 developed an innovative technology designed to generate functional articular cartilage from the patient’s own skin or adipose tissue with the potential to treat osteoarthritis. The company also moved into the second phase of its existing research agreement with global Japanese pharmaceutical company Rohto Pharmaceutical Co., Ltd.; appointed a new chief executive officer; and presented comprehensive findings from Parkinson’s disease program at the Society for Neuroscience Annual Meeting, Neuroscience 2015.

In regards to its wholly owned subsidiary, ISCO in the third quarter completed clinical testing of a new compound, which the company intends to utilize in substantially new skin care products to be marketed by its subsidiary Lifeline Skin Care, Inc., starting December 2015. Lifeline Skin Care launched its ProPlus+ professional line of products that will be available exclusively through Lifeline’s network of dermatologists, aestheticians and med spas.

Q3, YtD Financial Results

For the quarter ended in September 2015, ISCO reported revenues of $2.14 million, an increase of 9% over revenue of $173,000 posted in the third quarter of 2014. The company’s Lifeline Cell Technology sales increased by 22%, or $220,000, while Lifeline Skin Care sales decreased by 5%, or $47,000; both wholly owned subsidiaries remain profitable. ISCO’s consolidated net loss for the quarter was $539,000 compared to consolidated net loss of $2.0 million for the third quarter last year.

Total consolidated revenue for the nine months ended September 30, 2015, was $5.57 million, an increase of 7%, or $373,000, vs $5.20 million in revenue reported for the comparable period of 2014. Lifeline Cell Technology sales increased by 9%, or $244,000, while Lifeline Skin Care sales decreased by 5%, or $129,000. ISCO’s consolidated net loss for the nine months ended September 30, 2015, was $1.1 million vs a consolidated net loss of $7.9 million for the comparable nine months of last year, which the company partially attributes to the completion of multiple preclinical studies during the first six months of 2015.

ISCO ended the third quarter of 2015 with cash balance of $599,000. As of September 30, 2015, stockholders’ equity totaled $834,000.

Using its core technology, which results in the creation of pluripotent human stem cells from unfertilized oocytes (eggs), ISCO is focused on the therapeutic applications of human parthenogenetic stem cells (hpSCs) and the development and commercialization of cell-based research and cosmetic products. ISCO scientists have created the first parthenogenetic, homozygous stem cell line that can be a source of therapeutic cells for hundreds of millions of individuals of differing genders, ages and racial background with minimal immune rejection after transplantation. hpSCs offer the potential to create the first true stem cell bank, UniStemCell™. ISCO also produces and markets specialized cells and growth media for therapeutic research worldwide through its subsidiary Lifeline Cell Technology (www.lifelinecelltech.com), and stem cell-based skin care products through its subsidiary Lifeline Skin Care (www.lifelineskincare.com).

For more information visit at www.internationalstemcell.com.

International Stem Cell Corp. (ISCO) Bypasses Embryonic Ethical Debates by using Non-Embryonic Stem Cells for Research

November 9, 2015

The ethical controversy surrounding stem cell research does not reach the International Stem Cell Corp. as it employs non-embryonic cells (unfertilized) for exploring and attempting to treat different diseases. The company has developed the first collection of non-embryonic human stem cells that are stored in the UniStemCell Bank. When properly stimulated, the unfertilized eggs begin dividing into usable cells called human parthenogenetic stem cells (hpSC). The process, called parthenogenesis, creates stem cells that are self-renewing and have high potential for being compatible with a large portion of the population. A single cell line can treat millions of people with a low risk of immune rejection, a common issue in stem cell therapies. The company intends to use this system on eye, nervous system, and liver diseases with high expectations for successful results.

The controversy surrounding embryonic stem cell research begins with the view that life starts at conception with the embryo. The formation of a human stem cell line means the destruction of a human embryo. Therefore, the rights and status of an embryo are called into question.

Fortunately, the International Stem Cell Corp. side steps this controversy by using unfertilized embryos in its research. Stem cells have the capability of becoming any and all types of cells in the body, making them invaluable when combating degenerative diseases. However, the use of non-embryonic adult stem cells produces the possibility of immune rejection while embryonic cells lessen that chance. The company’s production of human leukocyte antigen genes (HLA) from parthenogenesis greatly diminishes this risk while keeping an ethical advantage.

The rapid division of these cells into usable regenerative ones means potentially effective cellular replacement therapies. The company has developed treatments for liver and retinal diseases that replace aged or damaged cells with newer ones. The company also recently announced its progression with clinical trials in treating Parkinson’s disease in Australia.

The International Stem Cell Corp. continues its goal of developing innovative restorative stem cell treatments for diseases that cause deterioration.

For more information, visit www.internationalstemcell.com

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International Stem Cell Corp. (ISCO) Advances Parkinson’s Disease Clinical Trials in Australia

November 3, 2015

California-based International Stem Cell Corporation this morning announced that its wholly owned subsidiary, Cyto Therapeutics, has signed a Letter of Intent (LOI) with Royal Melbourne Hospital in Australia to conduct phase I/IIa clinical trials of ISCO’s proprietary human parthenogenetic neural stem cells (hPNSCs) for the treatment of Parkinson’s Disease.

The LOI follows a recent meeting with Australian Therapeutics Goods Administration (TGA), and precedes a full agreement expected to be signed after TGA and the HREC approve the clinical protocol for the trials.

“We had a productive meeting with TGA where we discussed the clinical protocol and potentially came to an agreement on all remaining items. We look forward to receiving TGA approval for clinical trials in November and enrolling patients soon thereafter,” Russell A. Kern, Ph.D., chief scientific officer of ISCO, stated in the news release.

ISCO’s Parkinson’s disease program uses hPNSCs, a novel therapeutic cellular product derived from the company’s proprietary human pluripotent stem cells. hPNSC are self-renewing multipotent cells that are precursors for the major cells of the central nervous system. The cells’ ability to differentiate into dopaminergic neurons and express neurotrophic factors to protect the nigrostriatal system creates a potential new opportunity for the treatment of Parkinson’s disease.

Additionally, hpSCs offer the potential to create the first true stem cell bank, UniStemCell™. ISCO also produces and markets specialized cells and growth media for therapeutic research worldwide through its subsidiary Lifeline Cell Technology (www.lifelinecelltech.com), and stem cell-based skin care products through its subsidiary Lifeline Skin Care (www.lifelineskincare.com).

For more information visit www.internationalstemcell.com

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International Stem Cell Corp. (ISCO) Also Develops Advanced Stem Cell Technology for Skin-Deep Results

October 27, 2015

A leader in regenerative medicine, International Stem Cell Corp. uses its parthenogenesis stem cell technology to address immune rejection and self-renewing cells. This technology uses unfertilized eggs that have cells with a duplicate set of human leukocyte antigen genes (HLA) that lessen the chance of a body rejecting cells. From this, scientists created self-renewing human parthenogenetic neural stem cells (hpNSC).

These cells have the capacity to replace dead and dying neurons while protecting existing ones in patients with Parkinson’s disease. In fact, the company recently presented its preclinical results for the treatment of the disease at Neuroscience in Chicago. Furthermore, scientists with the company are currently developing cell technology to treat liver and retinal diseases.

The International Stem Cell Corp. also has a hand in anti-aging skin care products that uses its stem cell technology through its subsidiary Lifeline Skin Care. This technology is based on the communication between human cells. Protein molecules can carry messages that tell the surrounding cells to create new cells for tissue repair. The company removes those proteins from the parthenogenetic stem cells then creates microscopic bubbles called nanospheres to protect them from exposure. These tiny bubbles are then infused with vitamins, minerals, moisturizers, and antioxidants to create a finished serum.

Lifeline Skin Care has a range of products that include overnight, daily, neck and eye firming, and cleanser creams that can improve the look and feel of skin.

The innovative stem cell based technology of the company is not limited to degenerative diseases of the body. Skin can also benefit from parthenogenesis through the addition of healthy cells that prevent the look of aging though rejuvenation. Proceeds from the skin care line help support research for Parkinson’s, liver, and blindness diseases.

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

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International Stem Cell Corp. (ISCO) Stays the Course in BioTech’s Regenerative Medicine Space

October 20, 2015

International Stem Cell Corp. continues its pursuit of advancing regenerative medicine through its use and research of stem cells in the white hot biotechnology space. ISCO uses parthenogenesis, a stem cell technology that makes use of unfertilized eggs to address immune system rejection. The eggs being used have mirroring sets of human leukocyte antigen genes (HLA) that reduce the chance of immune system rejection. Not to be overlooked, it’s worth noting that one line of these cells can treat multiple millions of people. The company can draw human parthenogenetic neural stem cells (hpNSC) from the unfertilized eggs for self-renewing processes that are integral to the degeneration process.

Following continuous successful testing, International Stem Cell Corp. suggests that their human parthenogenetic neural stem cells can take the place of dead and dying neurons while also protecting existing ones when transplanted into the brain of someone with Parkinson’s disease. Further, company researchers and scientists are progressing toward developing human retinal epithelium (RPE) cells that are used in the treatment of eye diseases like age-related macular degeneration. Along with that research, the company is one of the world’s select few to develop a method for creating corneal tissue and cells to treat blindness.

International Stem Cell has recently announced its development of technology that creates functional cartilage from a person’s skin to treat a joint disease that erodes cartilage infamously known as osteoarthritis. The company is also making strides aside from therapeutic systems that, according to Chief Scientific Officer, Ruslan Semechkin, PhD, “can potentially be treated with the patient’s own cells.”

Running concurrent with its work in the area of regenerative techniques, International Stem Cell Corp. runs a cosmeceutical line called Lifeline Skin Care Inc. This business makes cosmetic skin care products all over the globe. The company’s research and development in this area uses parthenogenetic stem cells, vitamins and minerals to create a rejuvenating serum leading to healthier skin.

International Stem Cell Corp. works on therapeutic applications of human parthenogenetic stem cells and the development and commercialization of cell-based research and cosmetic products. The company’s primary technology of parthenogenesis nets the creation of pluripotent human stem cells from unfertilized oocytes. Company scientists have created the first parthenogenetic, homozygous stem cell line that is considered by many to be a source of therapeutic cells for hundreds of millions of individuals of differing genders, racial background and ages.

For more information about the company, visit www.internationalstemcell.com

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International Stem Cell Corp. (ISCO) to Present Comprehensive Findings for Parkinson’s Disease Program Preclinical Studies at Society for Neuroscience Annual Meeting

October 14, 2015

International Stem Cell Corp., a California-based biotech company developing novel stem cell-based therapies and biomedical products, this morning said it will make an oral presentation on the comprehensive results of its preclinical development of human parthenogenetic neural stem cells (hPNSCs) for the treatment of Parkinson’s Disease at the upcoming Neuroscience 2015 in Chicago.

The session, entitled, “Therapeutics of Parkinson’s Disease: Preclinical Studies,” will take place October 20 from 8 a.m.-10:15 a.m. ET.

“The comprehensive data collected from our extensive GLP studies serve as proof of safety and efficacy for our planned clinical trial for the treatment of Parkinson’s Disease in Australia. We look forward to providing an update on the status of our regulatory submission to the Australian government in the near future,” Russell A. Kern, Ph.D. chief scientific officer of ISCO, stated in the news release.

ISCO’s Parkinson’s disease program uses human parthenogenetic neural stem cells (hPNSC), which are a novel therapeutic cellular product derived from ISCO’s proprietary human pluripotent stem cells. hPNSC are self-renewing multipotent cells that are precursors for the major cells of the central nervous system. The ability of hPNSC to differentiate into dopaminergic neurons and express neurotrophic factors to protect the nigrostriatal system offers a new opportunity for the treatment of Parkinson’s disease.

ISCO also produces and markets specialized cells and growth media for therapeutic research worldwide through its subsidiary Lifeline Cell Technology (www.lifelinecelltech.com), and stem cell-based skin care products through its subsidiary Lifeline Skin Care (www.lifelineskincare.com).

For more information visit www.internationalstemcell.com

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International Stem Cell Corp. (ISCO) Continues Stem Cell Based Research and Development to Promote Rejuvenation of Dying Cells

October 6, 2015

The International Stem Cell Corporation, a biotechnology company, continues its developmental research of using stem cells to advance regenerative medicine. The company uses stem cell technology called parthenogenesis that uses unfertilized eggs to address immune system rejection. These eggs have duplicate sets of human leukocyte antigen genes (HLA) that lessen the chance of immune rejection. A single line of these cells can treat millions of people. Furthermore, ISCO can draw hpNSC (human parthenogenetic neural stem cells) from the unfertilized eggs for self-renewing processes related to degeneration.

For example, after continuous successful testing, ISCO believes that their hpNSC can replace dead and dying neurons while also protecting existing ones when transplanted into the brain of someone with Parkinson’s disease. Likewise, ISCO scientists have taken steps to develop human retinal epithelium (RPE) cells that can treat many eye diseases like age-related macular degeneration. Along with that research, the company is among the first in the world to develop a method (CytoCor) for creating corneal tissue and cells to treat blindness.

ISCO recently announced its development of technology that creates functional cartilage from a person’s skin to treat osteoarthritis, a joint disease that erodes cartilage. The company is also pursuing other therapeutic systems that “can potentially be treated with the patient’s own cells,” said its chief scientific officer, Ruslan Semechkin, PhD.

While continuing to develop new regenerative techniques, ISCO also maintains a cosmeceutical line called Lifeline Skin Care Inc. This business manufactures cosmetic skin care products around the world. It uses parthenogenetic stem cells along with vitamins and minerals to create a rejuvenating serum that promotes healthy skin.

For more information about ISCO, visit www.internationalstemcell.com

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International Stem Cell Corp. (ISCO) Develops Breakthrough Technology to Treat Osteoarthritis

September 30, 2015

International Stem Cell Corp., a biotechnology company developing novel stem cell-based therapies, announced that its scientific team has developed a robust innovative technology to generate functional articular cartilage from the patient’s own skin or adipose tissue to treat osteoarthritis. ISCO believes this technology may allow the company to provide relief to patients suffering from osteoarthritic knee joints, as well as to those with shoulder joints and intervertebral spinal disk osteoarthritis.

Ruslan Semechkin, ISCO’s chief scientific officer, stated, “While we are working on obtaining regulatory approval for the Parkinson’s disease treatment in Australia, as well as in the US, we are also pursuing a number of other therapeutic indications including osteoarthritis, which can potentially be treated with the patient’s own cells.”

Even though osteoarthritis is prevalent in our society, there is a lack of an effective treatment for this disease. Developing and successfully testing a scalable system that permits the generation of functional human cartilage tissue with superior mechanical properties is a significant accomplishment. The capacity to provide greater stability than other tissue that is currently available for the treatment of osteoarthritis is even more impressive.

Osteoarthritis is a degenerative joint disease characterized by progressive erosion of the articular cartilage. Although osteoarthritis can damage any joint in the body, the disorder most commonly affects joints in the hands, knees, hips and spine. The erosion of articular cartilage leads to joint pain, stiffness, and impaired mobility. According to the Arthritis foundation osteoarthritis affects over 27 million Americans with an estimated medical costs of as much as $65 billion.

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

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International Stem Cell Corp. (ISCO) Stem Cell Therapy Commercialization Progress on the Verge of Major Milestones

September 28, 2015

Stem cell technology’s real untilled and still extremely fertile soil is the therapeutics market, where injected cells could help repair damaged tissue systems and thus effectively treat many conditions, including degenerative ones, for which the current standard of care is often palliative at best. Dealing with the underlying cause of a given condition, through the gradual replacement and/or reinforcement of an impaired tissue system or organ using injected stem cells, represents a true paradigm shift in how we think about treating many of today’s most debilitating diseases. However, to tap into the rich spoils of this as yet largely undiscovered country, requires a mix of technologies and logistical capabilities, of which tragically few companies today can seriously boast.

One company that doesn’t need to boast, as it has clearly achieved both the capacity to proprietarily differentiate adult human cells by chemically stimulating unfertilized donor eggs, as well as provide long-term, storable, high-quality stem cell product for real-world, commercial-scale therapeutic applications, is International Stem Cell Corp. At the core of the company’s pipeline of rapidly emerging therapeutics is its parthenogenesis technology, whereby the company can create large batches of pluripotent (able to develop into any type of cell), human parthenogenetic stem cells (hpSCs), and do so in a completely ethical fashion. The company’s proprietary stimulation and differentiation technology also helps resolve the one major stumbling block facing stem cell therapies, immune rejection by the host. The company’s ability to make large batches of adult human cells from stem cells that are either specifically immune-matched to the donor, or immune-matched to the general population, gives ISCO an open road to therapy development, and the company has the testing to back up its technology too.

ISCO’s nine-month, 300 subject rodent model safety study, testing the tumorigenicity (propensity to promote tumor formation/growth) of its human neural stem cells (hpNSCs), which have been developed for the treatment of Parkinson’s disease (PD), was submitted back in July as part of the build up to phase 1/2a human clinical trials in Australia. This study followed up on earlier results by ISCO with its hpNSCs, showing no tumors in any of the animals receiving neural stem cell transplants. The demonstrated ability of injected hpNSCs to create new neurons that produce the primary neurotransmitter, dopamine (with whose falloff PD is causally associated), as well as exhibit a neuroprotectant effect on surviving neurons makes this technology a potential gold mine if human clinical trials yield good results.

Given that PD is a progressive, degenerative disorder, and that the current standard of care, oral levodopa (L-dopa), is associated with progressively worse periods where symptoms manifest themselves fully, called “off” periods, there hasn’t really been a good long-term solution for addressing the unmet needs of a majority of PD patients. This majority of PD patients, for whom the current standard of care so often feels like they are just postponing the inevitable succumbing to the disease’s impairments, are plagued by the frequency and intensity of relapse periods increasing as the disease progresses using L-dopa. ISCO isn’t trying to mask the problem chemically with synthetic dopamine, the company has developed injectable replacement neurons to treat the underlying brain tissue degeneration, and hopefully actually restore full functionality to the patient.

According to a new study out by research and consulting firm, GlobalData, the PD treatment market for just the U.S., Brazil, Japan, and the major EU member states is on track to hit upwards of $4.7 billion by 2022. However, newly FDA-approved market entrants, such as Xadago (safinamide) – a drug which blocks the primary enzyme which break down dopamine, from Zambon and its SIX Swiss Exchange-traded partner Newron Pharmaceuticals (SWX: NWRN) – or Impax Laboratories’ (NASDAQ: IPXL) RYTARY, an extended-release oral capsule formulation of carbidopa-levodopa – still do not address the underlying causes of the disease. It is up to a company like ISCO to bring forth a real therapeutic treatment option here, with ethical stem cell technology that can actually regenerate the damaged tissue system(s). With PD, given its progressive nature, it is not unthinkable that periodic injections, or simply a thorough course of therapeutic treatments with hpNSCs, could restore the patient to full functionality.

A good indicator of this potential is ISCO’s parallel hpNSC therapy pipeline for stroke, where preclinical data indicates that injections administered even several weeks after the stroke could actually reverse the typically associated functional deficits completely. The alternative to such a therapy in the case of a stroke is often grueling physical therapy, required in order to get back or re-learn lost motor function. But with ISCO’s treatment option on the table, stroke could be handled in the future with a simple injection regimen, even well after the initial stroke hospitalization. The tremendous potential of hpNSC therapy in strokes speaks volumes about what that same therapy can do for PD patients, given that both are maladies of the CNS, and that the therapy functions by replacing damaged neurological tissue.

To dig deeper, visit www.internationalstemcell.com

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International Stem Cell Corp. (ISCO) Appoints Ms. Ebrahimi as CFO

September 22, 2015

Today before the opening bell, International Stem Cell Corp. announced that Mahnaz Ebrahimi will be taking over as the new Chief Financial Officer, effective September 14, 2015. The prior CFO, Jay Novak, ended his employment in May.

Ms. Ebrahimi is a Certified Public Accountant, a Certified Equity Professional and a Certified Cash Manager. She has more than 25 years of experience in financial management and accounting of growing research-driven companies in the life sciences, biotechnology, and pharmaceutical sectors. Most recently, she has been assisting several biotechnology and technology companies on accounting and SEC related matters in an expert consultancy capacity, including Flux Power Holdings, Polaris Pharmaceuticals and Ocera Therapeutics.

From 2010 until an acquisition took place in 2012, Ms. Ebrahimi served as Director of Finance and Planning, as well as Treasury, of eBioscience. She also served as Vice President of Finance and Administration and Chief Financial Officer of Profil Institute for Clinical Research from 2003 to 2005. From 1989 to 2000, she served as Director of Finance & Treasury and Assistant Controller of Agouron Pharmaceuticals, which became a subsidiary of Pfizer in 2000.

For those unfamiliar with International Stem Cell Corp., it is a California-based biotechnology company focused on the therapeutic applications of human parthenogenetic stem cells (hpSCs) and the development and commercialization of cell-based research and cosmetic products. ISCO’s core technology, parthenogenesis, results in the creation of pluripotent human stem cells from unfertilized oocytes (eggs). ISCO also produces and markets specialized cells and growth media for therapeutic research worldwide through its subsidiary Lifeline Cell Technology, and stem cell-based skin care products through its subsidiary Lifeline Skin Care.

For more information, visit www.internationalstemcell.com

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International Stem Cell Corp. (ISCO) Immense Therapeutic Potential of Scalable, Ethically-Derived Stem Cell Tech on Display at Rodman & Renshaw

September 17, 2015

The promise of stem cell tissue transplantation is particularly exciting for conditions such as Parkinson’s disease, an incurable and progressive disorder of the nervous system characterized by a gradual at first, and then increasingly severe impairment of various motor control faculties. Parkinson’s disease makes a good poster child for the enormous potential of stem cell therapy in other diseases/conditions, because it is materially defined by a localized degeneration of neurons, making targeted replacement therapy via injected cells extremely appealing.

International Stem Cell Corporation (OTCQB: ISCO) is at the forefront of developing such therapies via its capacity to produce pluripotent (having the ability to develop into essentially any cell in the human body), non-embryonic, human parthenogenetic stem cells (hpSCs), such as its lead product candidate, human neural stem cells (hpNSCs). And because hpNSCs have produced abundant evidence thus far that they can not only differentiate into neurons that help produce the primary neurotransmitter whose falloff is associated with Parkinson’s disease, dopamine, but can also directly express neuroprotectant capabilities, the potential for treating other incurable CNS diseases like multiple sclerosis, muscular dystrophy, or Lou Gehrig’s disease, is effectively on the table.

Moreover, because the company’s proprietary technology for creating pluripotent hpSCs utilizes unfertilized eggs, which are chemically stimulated to begin the process of division before being differentiated into either patient specific human leukocyte antigen-matched and histocompatible (heterozygous) hpSCs or HLA homozygous hpSCs that are immune-matched for compatibility with the vast majority of the population, ISCO’s technology constitutes an end run on the ethical controversy that has plagued stem cell research. At the same time, because a relatively small series of human leukocyte antigen (HLA) homozygous cell lines could effectively present treatment options which are suitable for huge swathes of the human population, ISCO has at its disposal a methodology for creating commercial scale volumes of cells (for therapeutic or research purposes) that resolves the stem cell industry’s primary procedural stumbling block, immune system rejection.

This is a significant advantage when it comes to research purposes and ISCO has already taken up the lead in the sector, creating the world’s first true human stem cell bank, UniStemCell™, a growing collection of non-embryonic histocompatible stem cells. The ability to go to an “off-the-shelf” cell line from the bank that is immune-matched to millions of individuals is also key when it comes to developing frontline stem cell therapies. Hence the buzz about the company’s rapidly developing therapeutic pipeline that covers several unmet needs, like neural stem cells for treating CNS maladies such as Parkinson’s disease and stroke, liver cells for treating even severe metabolic liver diseases such as Crigler-Najjar syndrome, and corneal/retinal cells for treating corneal blindness, as well as macular degeneration.

ISCO’s ongoing development of a powerful hpNSC based therapeutic solution for Parkinson’s disease will soon see a critical milestone in the phase I/IIa clinical trial set to take place in Australia, and the company’s recently submitted animal model study, showing that no tumors were observed in a battery of 300 rodents, gives investors a really good idea about how safe and effective such injected stem cell therapy could be for humans. Already commercially successful via its Lifeline Skin Care subsidiary, which saw an 18 percent Q2 jump in YOY revenue to $1.82 million, on the strength of sustained growth for revitalizing skin care products, International Stem Cell Corporation is also dedicated to helping the life sciences industry meet its own clinical research needs by providing a vast array of specialized cells and growth media through its Lifeline Cell Technology subsidiary.

ISCO’s CSO and board member, Ruslan Semechkin, PhD, offered attendees at the Rodman & Renshaw 17th Annual Global Investment Conference a general overview of such astounding capabilities, as well as a closer look at the company’s ongoing clinical and research programs. Investors who were unable to attend the conference can still get a good front seat look at the company’s therapeutic pipeline and ongoing programs, simply by visiting the company’s website at www.internationalstemcell.com.

Let us hear your thoughts: International Stem Cell Corp. Message Board

International Stem Cell Corp. (ISCO) Begins Next Phase of Research Collaboration with Rohto Pharmaceutical Co., Ltd. of Japan

September 8, 2015

Today before the opening bell, International Stem Cell Corp. announced that it has entered into the second phase of the existing Research Agreement with Rohto Pharmaceutical Co., Ltd. (“Rohto”), a global Japanese pharmaceutical company recognized as the second-largest consumer health company in Japan.

Rohto acknowledged that ISCO’s human parthenogenetic neural stem cells (hpNSCs) demonstrate consistent high quality and are suitable for further use in Rohto’s research. This was determined after successfully completing preliminary studies of ISCO’s proprietary cells. If Rohto successfully validates hpNSCs’ efficacy in rodent models, which could lead to a possible treatment of a variety of degenerative eye disorders, Rohto plans to enter into negotiations of a definitive license agreement with ISCO in order to license the company’s proprietary technology for therapeutic and commercial use.

“Based on hpNSCs known performance in various animal models we expect that in the next four months Rohto will be able to demonstrate the efficacy of these stem cells in treating retinal degenerative disorders,” stated Ruslan Semechkin, Ph.D., Chief Scientific Officer of ISCO.

For more information, visit www.internationalstemcell.com

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