Category Archives: International Stem Cell Corp. ISCO

International Stem Cell Corp. (ISCO) Neural Stem Cell Therapy – Ethical, Effective, and Homegrown

June 24, 2016

A news story out this week (http://dtn.fm/SW1v5) in the MIT Technology Review recounts the lamentable tale of a man (Jim Gass) who used to be chief legal counsel for storied electrical manufacturer Sylvania – for whom a desperate search to treat his stroke with stem cells abroad invariably led to disastrous medical tourism results. Based on a study conducted by the New England Journal of Medicine, the MIT Tech Rev article’s analysis further explains that the Gass case may have occurred in part due to Google parent company Alphabet (NASDAQ: GOOG; GOOGL), as the search engine’s paid ad returns to user queries about stem cell therapies seem partly responsible for steering people into the hands of shady clinics abroad.

I don’t know what that tells commercial investors about how midcap and microcap biotech innovators are overlooked, but it tells me everything I need to know about the future of the stem cell sector, because the next decade is primed to witness unprecedented change due to emergent technologies.

This single case with Gass, where a man sought fetal tissue injections in countries like Argentina, China and Mexico, because he did not have access to domestic treatment options, paints a bold and cautionary tale about medical tourism. But it also tells a story about market potential and the huge sums of capital seeking therapy, that is currently trapped, like a spring that is ready to bounce, charged with breakout momentum. Think about Gass: the poor guy just wanted to offset the impact of his stroke and ended up with a tumor made of someone else’s tissue in his spine. Now, the former chief legal counsel for Sylvania is no schlub mind you, so this could happen to any consumer put in a similarly desperate situation. And Gass reportedly spent over $300,000 in the aggregate seeking treatments.

Let’s face the facts. We have been dragging our feet on stem cell technologies for far too long despite the massive bluesky therapeutic potential (especially when we bring personalized medicine vectors into the equation), so in many ways we created the problem. Only in recent years has the FDA begun to change its stance, and so we are late to the game on this one. While due in part to justifiable ethical concerns, the resulting sluggishness of our biotech sector has only been exacerbated by the FDA’s foot-dragging. However, with homegrown companies like revolutionary California-based biotech developer, International Stem Cell Corp. (OTCQB: ISCO), effectively in-play as the FDA continues to loosen its grip, this cautionary tale about Gass could soon go the way of the dinosaur.

The FDA cleared ISCO’s proprietary human parthenogenetic stem cell line for investigational clinical use back in 2014, and the company subsequently made significant headway across its continuously evolving therapeutic pipeline, where two of the current major vectors are Parkinson’s disease and ischemic stroke (the most prevalent type). In fact, the company just announced the results of its 12-month pre-clinical safety and efficacy primate study of its proprietary and readily expandable ISC-hpNSC® (human parthenogenetic stem cells-derived neural stem cells) platform, as being published in the well-respected and peer-reviewed journal, Cell Transplantation.

This publication marks the end of preclinical work for ISCO’s Parkinson’s disease program and confidence is now high at the company, with clinical trial approval of ISC-hpNSC® for the treatment of Parkinson’s disease secured, and Phase 1 clinical trial enrollment underway in Australia. Patients with moderate to severe Parkinson’s are cleared by the Melbourne Health Human Research Ethics Committee and ISCO’s groundbreaking study is being conducted at the Royal Melbourne Hospital in Australia. Great news, especially when one considers the results of a new landmark Mayo Clinic study (http://dtn.fm/3E6wT) published in JAMA Neurology, which shows a big uptick in Parkinson’s rates from 1976 to 2005, a trend whose forward projections look brutal, even in a best case scenario.

Given the extant evidence thus far showing that ISC-hpNSC improved Parkinson’s disease symptoms markedly in subjects, where dopaminergic neuron mass increased significantly, even as dopamine concentrations rose amid clear neurotrophic support from the therapy – the potential for the company’s neural stem cells in stroke demands a second look as well. It should come as no shock, even to lay investors, that the same kind of injectable ISC-hpNSC therapy able to address Parkinson’s disease can be used to also treat stroke. However, the actual data the company has put together to date on the efficacy of such treatment paints a far more compelling picture.

Being that the standard of care currently involves attempting to dissolve the blood clot within the first few hours after the initial event, followed up by only marginally effective and often extremely challenging rehabilitation work aimed at returning as much cognitive and functional capacity as possible to the patient – the advent of an actual stem cell-based therapy could change the stroke market completely. The National Stroke Association indicates that stroke is the fifth leading cause of death in America and that it is a leading cause of adult disability, alongside other neurological diseases/disorders such as Parkinson’s. According to a new Persistence Market Research report, North America continues to be the largest market by far for stroke diagnostics and therapeutics, with Asia set to experience high levels of growth in the next few years. This outlook jogs well with Transparency Market Research’s most recent publication on the sector, which projects a market worth $1.9 billion by 2020, growing at a CAGR of around 6.3 percent.

Pre-clinical data suggests that ISCO’s neural stem cell therapy approach not only addresses but can actually reverse the functional deficits associated with a stroke. What’s more, rather than needing to be applied within hours, the therapeutic benefits from such neural stem cell therapy can be accessed days, or even weeks after the stroke has occurred.

The advent of ISCO’s neural stem cell therapy would be a complete and total paradigm shift in the healthcare market when it comes to treating stroke, and the company is right here in our own backyard. Throw away your medical tourism passport America, and double down on ISCO.

For more information, visit www.internationalstemcell.com

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International Stem Cell Corp. (ISCO) Protecting its Technology Worldwide

June 14, 2016

A patent is essentially a government license that gives certain rights to the patent holder, excluding others from making, using, or selling a particular product or invention without permission. According to WIPO’s 2015 World Intellectual Property Indicators Report, there have been more than 2.7 million patent filings worldwide since 2013 and this number has grown significantly in recent years. The top three offices in the world have been in China, the U.S., and Japan. According to the report, the leading technology fields are computer technology, electrical machinery, measurement, and digital communication, with medical technology not far behind.

International Stem Cell Corporation (OTCQB: ISCO) is a publicly traded biotechnology company that promises to advance the field of regenerative medicine by addressing the problem of immune-rejection. Most recently, the company has focused its efforts on using unfertilized human eggs to create parthenogenetic stem cells to treat severe diseases of the eyes and nervous system, including diseases such as Parkinson’s. The company is careful to protect its associated intellectual property.

International Stem Cell Corporation protects its technology worldwide by filing and holding patent applications for its more specific stem cell lines, methods of production, and various research methods. So far, ISCO has 16 issued patents and 91 pending patents across 15 patent families, as well as a licensed portfolio of 25 patents or patents applications across eight patent families related to its skin care products. Most of International Stem Cell Corp.’s patents are filed internationally, covering the U.S., Canada, and a wide range of other industrialized countries.

The company’s technology strengths are backed up by a carefully chosen team of managers and scientists. ISCO’s directors, executive managers, and scientific advisors have been selected to benefit the company’s business and science related operations. Each person is skilled in particular aspects of corporate management or biotechnology, with executive managers specializing in systems analysis, strategic planning and corporate management, as well as financial management, accounting, medical genetics, embryology, and stem cell biology. This level of combined experience enables ISCO to function positively in every aspect of its business.

For more information, visit www.internationalstemcell.com

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Buy One get One Free with International Stem Cell Corporation (ISCO)

June 8, 2016

The recent initiation report on International Stem Cell Corporation (OTCQB: ISCO) by Edison Investment Research looks at the company from a novel perspective. Although described as ‘an early-stage cell therapy company currently in Phase I/IIa clinical trials to treat Parkinson’s disease (PD)’, the company is much more. It has two wholly-owned subsidiaries that are currently generating revenue. “These commercial businesses,” reads Edison’s report, “provide a floor under ISCO’s current valuation, creating an essentially free option” on ISCO’s biotech business devoted to the treatment of Parkinson’s disease. In other words, the analysts at Edison are saying that prospective investors can pay for the two subsidiaries and get the biotech business free.

The two subsidiaries are Lifeline Skin Care (LSC) and Lifeline Cell Technology (LCT). Lifeline Skin Care (LSC) develops and manufactures a line of luxury skincare products. The company globally markets these products through dermatologists, plastic surgeons, medical clinics, resort spas, other specialized channels and its website. Its major distributors are Amazon (NASDAQ: AMZN) and Dermstore. The LSC product line includes cleansers, exfoliators and a range of specialized moisturizers and serums. LSC’s potential for growth is enormous. The global skincare market is estimated at over $100 million and is growing at a CAGR of 3.3 percent, and LSC is certainly realizing its potential. Its revenues in recent years exploded at four times the industry rates, which were roughly 17 percent from 2012-2015.

Lifeline Cell Technology (LCT) is ISCO’s biomedical business. LCT develops, curates and markets human stem cells. Over the period from 2012-2015, revenue from ISCO’s biomedical business grew at a CAGR of 19 percent, or nearly three times the industry rate. These two subsidiaries comprise ISCO’s cosmeceutical and biomedical business lines.

Together, LSC and LCT had revenues of $7.5 million for the fiscal year ended December 31, 2015, with LSC reporting $3.5 million and LCT reporting $4 million. Edison expects revenues at the skincare business (LSC) to grow by 37 percent over the next 10 years, reaching $4.8 million by 2025. The biomedical subsidiary (LCT) is expected to do much better, more than doubling in size to get to $10.5 million over the same period.

Students of Brealey and Myers will remember that ‘we can think of stock price as the capitalized value of average earnings under a no-growth policy, plus PVGO, the present value of growth opportunities’. Such an approach values the cosmeceutical and biomedical businesses at a risk-adjusted net present value of $26 million, or $9.30 per share. To arrive at net present value (NPV), future cash flows were discounted at 10%. The risk adjustment to the NPV was 90%.

ISCO’s biotech business, revolving around the treatment of Parkinson’s disease, is valued at $31 million, or $10.90 per share, and the NPV of future general and administrative expenses works out to -$30 million, which just about cancels that out. Edison is estimating the chance that biotech revenues will materialize at about 1 in 13, or 7.5 percent. Also, there’s no valuation placed on the rest of the biotech business. If you like bargains, this might be one.

For more information, visit www.internationalstemcell.com

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International Stem Cell Corp. (ISCO) Advancing Clinical Development Program for Parkinson’s Disease

June 2, 2016

International Stem Cell Corp. (OTCQB: ISCO) is a biotechnology company that works with parthenogenesis to treat diseases of the eyes, the nervous system, the liver, and more. Currently, ISCO is preparing for a phase I clinical trial of its proprietary human parthenogenetic stem cells-derived neural stem cells (ISC-hpNSC®) for the treatment of Parkinson’s disease (PD), a disease of the nervous system that affects mainly middle-aged and elderly people. The disease is marked by tremors, muscular rigidity, and slow movements. The company’s lead product, ISC-hpNSC, works in a different way than other conventional treatments. The stem cells enable protection of the remaining, fully-functional neurons of Parkinson’s disease patients. The testing ISCO has done on mice, rats, and non-human primates has backed its theory that a one-time transplant of ISC-hpNSC could alleviate current PD symptoms and prevent the disease from spreading.

Recently, Edison, an international equity research firm, initiated coverage on International Stem Cell Corp. The report focuses on ISCO’s parthenogenetic stem cell technology and how this technology has the potential to treat a variety of diseases. The report also includes an investment summary, a description of ISCO as a company, an outline of Parkinson’s disease, insight into ISCO’s cosmeceutical and biomedical business lines, a valuation, and a financial overview.

With the help of Cryoport, the world’s premier cryogenic logistics firm, International Stem Cell Corp. is rapidly approaching the start of its phase I clinical trial for the treatment of Parkinson’s disease. So far, there have been a number of cell therapy and gene therapy treatments that have been evaluated to find the cause of Parkinson’s. The studies ISCO has undertaken on non-human subjects have shown significant results.

According to the initial coverage issued by Edison: “ISCO presented results of its PD preclinical studies in October 2015 at Neuroscience 2015 in Chicago. The preclinical studies on 18 non-human primates showed that at 12 months, the transplanted cells had integrated into the dopamine fibers and dopamine levels post-mortem were significantly higher in the transplanted group versus the control group.”

As part of its impending clinical study, each patient will receive a scan at the beginning of the trial and at the six-month and 12-month lines after the procedure. Although these procedures do come with risks, they will be performed at the well-known Royal Melbourne Hospital in Australia and, if successful, could lead to larger phase II trials in 2017/2018.

For more information, visit www.internationalstemcell.com

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International Stem Cell Corp. (ISCO) Publishes Results from Preclinical Study of ISC-hpNSC® for Treatment of Parkinson’s Disease

Before the opening bell, International Stem Cell Corp. (OTCQB: ISCO) announced the publication of results from a 12-month preclinical, non-human primate study. The data highlights the safety and efficacy of ISCO’s proprietary human parthenogenetic stem cells-derived neural stem cells (ISC-hpNSC®) for the treatment of Parkinson’s disease. According to the results of this study, transplantation of the neural cells was both safe and well tolerated by non-human primates, with the animals demonstrating no serious adverse events throughout the 12-month trial.

“The publication of the data in the peer-reviewed and highly-respected journal, Cell Transplantation, brings to conclusion the preclinical stage of ISCO’s Parkinson’s disease program,” Russell Kern, Ph.D., chief scientific officer of ISCO, stated in this morning’s news release. “The data provides further evidence that parthenogenetic neural stem cells can be effective in treating the symptoms of Parkinson’s disease and, along with the previously [submitted] safety data, formed the basis of our application to the Australian regulatory authorities to move this program into the clinic.”

To view the full article and abstract, visit http://dtn.fm/kB2eZ

Review of data stemming from this preclinical study played a key role in ISCO’s authorization from the Therapeutics Goods Administration of Australia to initiate a phase I/IIa clinical trial of its innovative ISC-hpNSC for the treatment of moderate to severe Parkinson’s disease. In December, the company announced this approval and entered into a master clinical research agreement with the Florey Institute of Neuroscience and Mental Health, one of the world’s leading brain research centers, to conduct the impending dose escalation trial. In March, ISCO commenced enrollment for its phase I trial. Preliminary clinical data stemming from this study is expected in the fourth quarter of this year.

According to the Parkinson’s Disease Foundation, an estimated seven to 10 million people worldwide are currently living with Parkinson’s disease, making it the second most common neurodegenerative disease. Currently without a cure, the combined direct and indirect costs stemming from this debilitating condition, including treatment, social security payments and lost income from inability to work, are estimated at $25 billion per year in the United States alone.

In preclinical studies, ISCO’s ISC-hpNSC have shown effective in improving Parkinson’s disease symptoms by increasing the presence of dopaminergic neurons and bolstering dopamine concentration in the brain through neurotrophic support and dopaminergic neuron replacement. In particular, the cells’ ability to replace and protect dopaminergic neurons while restoring neural function is expected to offer significant potential benefit to patients suffering from moderate to severe Parkinson’s disease.

For more information, visit www.internationalstemcell.com

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International Stem Cell Corp. (ISCO) Moves toward Commencement of Phase I Clinical Trial through Partnership with Cryoport

May 26, 2016

Earlier this week, Cryoport, Inc. (NASDAQ: CYRX), the world’s premier cryogenic logistics firm, announced a strategic partnership with International Stem Cell Corp. (OTCQB: ISCO) through which it will provide global logistics support for ISCO’s impending Phase I clinical trial of its human parthenogenetic stem cell-derived neural stem cells (ISC-hpNSC) for the treatment of moderate to severe Parkinson’s disease. Cryoport’s strategically located cryogenic facilities in Southern California and Singapore are expected to play a key role in ISCO’s efforts to maintain its cell therapy as it is transported around the globe to the study’s site, Australia’s Florey Institute of Neuroscience and Mental Health, which is one of the world’s foremost brain research centers.

“This trial will take place across the globe and it is imperative that our cell therapy maintains integrity,” Dr. Russell Kern, executive vice president and chief scientific officer of ISCO, stated in a news release. “We are pleased to have Cryoport handle our global logistics requirements.”

The partnership with Cryoport marks the latest in a collection of recent milestones related to ISCO’s highly-anticipated clinical program. After receiving authorization to initiate a Phase I/IIa clinical trial of ISC-hpNSC from the Therapeutics Goods Administration of Australia in December, the company quickly entered into a master clinical research agreement with the Florey weeks later. In March, ISCO announced its entry into definitive agreements for the private placement of $6.3 million of its convertible preferred stock, along with purchase warrants covering an additional $25.7 million of the company’s common stock, effectively strengthening its cash position in order to fund its Phase I trial. ISCO also commenced enrollment for the study in March, with preliminary clinical data expected as soon as the fourth quarter of this year.

Parkinson’s disease currently affects roughly 6.3 million people around the world, about 15 percent of whom develop the condition before reaching the age of 50, according to data from the European Parkinson’s Disease Association. Parkinson’s is caused by the degeneration of the substantia nigra portion of the brain, which is characterized by its dopaminergic neurons. When these neurons die, the brain becomes deprived of dopamine, resulting in symptoms such as tremors, rigidity and impaired balance. According to the National Parkinson Foundation, approximately 80 percent of all dopamine-producing cells are typically lost before the motor symptoms of Parkinson’s disease present themselves.

ISCO is taking aim at this devastating condition through the use of regenerative medicine. Through its proprietary ISC-hpNSC product candidate, the company is seeking to introduce a new approach to treating Parkinson’s that involves replacing the dead dopaminergic neurons with healthy neural cells while also protecting the brain by expressing neurotrophic factors. In preclinical testing, the candidate has been shown effective in both alleviating current symptoms and preventing further deterioration.

“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,” Dr. Andrey Semechkin, chief executive officer of ISCO, added in a news release.

For more information, visit www.internationalstemcell.com

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Edison Issues Initiation on International Stem Cell Corp. (ISCO), Focus on Parkinson’s Potential

May 25, 2016

In a May 16, 2016, press release, Edison Investment Research announced initiation of coverage on International Stem Cell Corp. (OTCQB: ISCO). Edison describes itself as an international equity research firm with over 110 analysts and professionals, working with both large and small companies, as well as investors, wealth managers, private equity and corporate finance houses.

Edison’s focus on International Stem Cell Corp. centers around ISCO’s unique parthenogenetic stem cell technology platform, and its anticipated superior therapeutic potential for addressing health problems, specifically Parkinson’s disease. Parthenogenetic stem cells (hpSC) are generated from unfertilized eggs, meaning no viable human embryo is created or destroyed. The resulting cells thus bypass ethical issues. At the same time, parthenogenetic stem cells express fewer parental histocompatibility antigens, thus offering important immuno-matching advantages and significantly reducing the risk of immune system rejection.

ISCO parthenogenetic stem cells are seen as offering important qualities for the treatment of liver and eye diseases, as well as diseases of the central nervous system such as Parkinson’s. Of primary interest are diseases where, according to ISCO: “cell therapy has been clinically proven, but treatment options are limited by the availability of safe human cells”.

Parkinson’s disease (PD) represents an especially important target market. The Edison report states that:

“As many as 2-3 million people suffer from PD in the US and EU, according to the Parkinson’s Disease Foundation (PDF), and there are currently no approved treatments to slow or halt progression of the disease. If ISCO’s treatment proves effective at slowing or halting disease progression, we forecast potential peak sales of $2.8bn based on 2% of existing and 5% of newly diagnosed patients in the US and 1-2% of patients in the EU and RoW receiving treatment.”

The report also points out that ISCO has other commercial operations that leverage its hpSC technology, operations that provide revenue to support continued research into therapeutic applications. According to the report:

“Using a risk-adjusted NPV model, we value the company at $27m or $9.60 per basic share, using a 12.5% discount rate and a 7.5% probability of success for the PD candidate and a 10% discount rate and 90% probability for the skincare and biomedical businesses.”

To view the full Edison report, go to http://dtn.fm/wSz7R

For more information, visit www.internationalstemcell.com

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International Stem Cell Corp. (ISCO) Teams with Leading Cryogenic Logistics Provider for Impending Clinical Trial

May 23, 2016

Before the opening bell, Cryoport, Inc. (NASDAQ: CYRX), a premier provider of cryogenic logistics solutions to the life sciences industry, announced a strategic partnership with International Stem Cell Corp. (OTCQB: ISCO) through which it will provide global logistics support to ISCO for its impending phase I clinical trial. ISCO received authorization to begin a phase I/IIa clinical trial of its human parthenogenetic stem cell-derived neural stem cells (ISC-hpNSC) in patients with moderate to severe Parkinson’s disease from the Therapeutic Goods Administration of Australia in December, and the company commenced patient enrollment for the study earlier this year.

As the premier cryogenic logistics provider, Cryoport will leverage two of its strategically located depots, including locations in southern California and Singapore, to safely move ISCO’s high-value biologic material from its research facility in California to the study site in Australia. Cryoport’s proven track record in the logistics space, particularly as it relates to clinical trials and commercialization programs, makes it an ideal option for ISCO moving forward.

“This trial will take place across the globe and it is imperative that our cell therapy maintains integrity,” Russell Kern, PhD, executive vice president and chief scientific officer of ISCO, stated in a news release. “We are pleased to have Cryoport handle our global logistics requirements.”

Through its partnership with Cryoport, ISCO moves one step closer to the commencement of its highly-anticipated clinical trial. In December, the company signed a clinical service agreement with the Florey Institute of Neuroscience and Mental Health, one of the world’s leading brain research centers. In March, ISCO entered into definitive agreements with two institutional healthcare investors and management for the private placement of $6.3 million of the company’s convertible preferred stock, adding capital that’s expected to drive its phase I study in the months to come.

As its scientists continue to evaluate additional therapeutic indications for its innovative stem cell technology platform, ISCO is primed to rapidly expand its presence in the biotechnology space. Leveraging partnerships with Cryoport and the Florey Institute of Neuroscience and Mental Health, the company will look to build on its current momentum while working toward the release of preliminary safety and efficacy clinical data from its upcoming study by the end of the year.

For more information, visit www.internationalstemcell.com

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International Stem Cell Corp. (ISCO) Covered in Report by Edison Investment Research

May 20, 2016

Earlier this week, Edison Investment Research, a leading independent investment intelligence firm, commenced coverage of International Stem Cell Corp. (OTCQB: ISCO). In the initial report, Edison gives prospective investors an in-depth look at ISCO’s current market position, including its impending Phase I/IIa clinical trials for the treatment of Parkinson’s disease, as well as its revenue-generating subsidiaries, Lifeline Skin Care and Lifeline Cell Technology, which Edison suggests ‘provide a floor under ISCO’s current valuation, creating an essentially free option on the PD candidate’.

To view the full report, visit http://dtn.fm/fIF6B

Leveraging its innovative human parthenogenetic stem cell (hpSC) technology, ISCO has developed 15 unique stem cell lines capable of functioning as a variety of cell types, such as livers cells, neural cells and three-dimensional eye structures. Crucially, ISCO’s groundbreaking platform enables the advancement of regenerative medicine while avoiding the common ethical concerns that have gone hand-in-hand with embryonic stem cells. Using a risk-adjusted net present value methodology and taking the market potential of this technology into account, Edison valued ISCO at $27 million, or about $9.60 per share on an undiluted basis. While the company’s success is largely contingent on the successful execution of its Parkinson’s disease clinical trials and its ability to attract a licensing partner to move forward with additional testing, strong preclinical data in primate studies highlights the promise of ISCO’s hpSC technology as the company approaches commencement of its Phase I clinical trial in Australia.

“Promising preclinical results support our expectation that ISC-hpNSC will bring a long-needed solution for patients suffering from Parkinson’s disease,” Russell Kern, PhD, executive vice president and chief scientific officer of ISCO, stated in a news release. “The ability of our approach to replace and protect dopaminergic neurons and restore neural function offers significant potential benefit to patients. We look forward to preliminary clinical data in Q4 2016.”

Over the next decade, Edison forecasts ISCO’s revenues through its cosmetic/skincare business to grow from $3.5 million to $4.8 million, achieving a compound annual growth rate of 3.2 percent, which is in line with forecast growth of the global skincare market. The research firm suggests that ISCO could begin generating profits stemming from the development of its stem cell technology by 2024, assuming the company’s promising preclinical results hold true throughout clinical testing.

For more information, visit www.internationalstemcell.com

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International Stem Cell Corp. (ISCO) Introducing a New Era of Medicine with its First Phase of Clinical Trials

International Stem Cell Corporation (OTCQB: ISCO) is a biotechnology company that focuses on early-stage cell therapy. ISCO uses stem cells to treat a variety of diseases, including those of the eyes, the nervous system, and the liver, among others. The scientists at ISCO treat severe diseases with state-of-the-art technology. The aim of the company is to create therapeutic products from its own intellectual property. With this in mind, ISCO also owns two subsidiary companies. Lifeline Skin Care Inc. is a business that develops and manufactures skin care products, while Lifeline Cell Technology, LLC is a research products business that develops and manufactures human cell culture products.

Most recently, International Stem Cell Corp. has started developing human parthenogenetic stem cell derived neural stem cells. Over the past few years, the main problem with using stem cells in regenerative medicine has been a case of ethics. In an article entitled ‘Embryonic stem cell research: an ethical dilemma’, published on the Euro Stem Cell website, it explains the dilemma that we, as humans, have to face when making a choice between two moral principles: the duty we have to prevent or diminish pain and suffering, and the duty we have to respect the value of human life, even at its earliest stages. In the article, the discussion goes into detail about the moral status of a human embryo. The question is asked: Does the embryo have the status of a person? The answer is still to be decided.

However, with the help of International Stem Cell Corp., the discussion can be put to one side for the time being. ISCO has developed a new type of stem cell using unfertilized eggs. This means that the eggs in question would never have the potential to become embryos, and, therefore, no embryo is destroyed. During a recent interview between The Nikkei Asian Review and Russell Kern, Chief Scientific Officer at ISCO, Kern said: “Being able to produce parthenogenetic stem cells in large quantities and in a way that greatly simplifies the chances of immune matching gives us a clear advantage over other stem cell technologies, like embryonic stem cells for obvious reasons. One of ISCO’s stem cell lines matches approximately 70 million people and makes it incredibly simple to immune match its stem cells.”

ISCO is starting a phase I clinical trial in Australia using these new stem cells. The stem cells not only take away any moral issues associated to the cause but may also reduce the risk of immune rejections. The phase I clinical trials are based on preclinical studies in rodents and nonhuman primates. The ISCO stem cells showed a significant rise in brain dopamine levels. Not only this, the studies also showed amazing improvement in Parkinson’s disease symptoms. With phase I of clinical trials, ISCO aims to find a treatment for Parkinson’s disease.

For more information, visit www.internationalstemcell.com

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International Stem Cell Corporation (ISCO) Reports Operating Results for First Quarter of 2016

May 17, 2016

Before the opening bell, International Stem Cell Corporation (OTCQB: ISCO) announced its operating results for the first quarter of 2016. The company’s consolidated revenue for the three months ended March 31 was $1.6 million, which remained unchanged from the comparable period of 2015. ISCO continued to generate revenue through its two wholly-owned subsidiaries, Lifeline Skin Care and Lifeline Cell Technology, with both remaining profitable. Profit margin for the two subsidiaries was $1.24 million, or 77 percent, for the three month period, up from $1.20 million, or 74 percent, in the previous year.

“I’m happy to report that while revenues remained flat, profit margin improved,” Andrey Semechkin, Ph.D., chief executive officer and co-chairman of ISCO, stated in this morning’s news release. “In addition our therapeutic development programs are proceeding according to plan.”

In recent months, ISCO has continued to focus on the clinical development of its groundbreaking human parthenogenetic stem cell-derived neural stem cells (ISC-hpNSC®) for the treatment of moderate to severe Parkinson’s disease. In December, the company receive authorization from the Therapeutics Goods Administration of Australia to commence the first human study of the cells, a phase I/IIa dose escalation trial. ISCO then entered into a clinical service agreement with the Florey Institute of Neuroscience and Mental Health, one of the world’s leading brain research centers, to conduct the trial.

In March, the company took two significant steps in the development of ISC-hpNSC®, including commencing enrollment for its impending phase I trial and raising capital with which to fund the study through a private placement. As part of this funding initiative, ISCO entered into definitive agreements with two institutional healthcare investors and management for the private placement of $6.3 million of the company’s convertible preferred stock, as well as common stock purchase warrants for an additional $25.7 million of ISCO’s common stock. Gross proceeds from this placement included $2.5 million in cash and conversion of $3.8 million in debt, which was owed to the company’s co-chairman and CEO.

“The recurring investment of these healthcare focused institutional investors is in support of and attests to the potential of our technology,” Semechkin added in a news release announcing the private placement. “The capital raised will help to drive our Phase 1 study of ISC-hpNSC® for the treatment of moderate to severe Parkinson’s disease. With enrollment of patients already underway, we look forward to the end of this year for preliminary safety and efficacy clinical data.”

For more information, visit www.internationalstemcell.com

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International Stem Cell Corporation (ISCO) passes another Milestone in its Quest for a Parkinson’s Cure

May 11, 2016

On March 7, 2016, International Stem Cell Corporation (OTCQB: ISCO) announced that the Melbourne Health Human Research Ethics Committee (HREC) had approved its application to initiate phase I clinical trials of ISC-hpNSC® (human parthenogenetic neural stem cells) for the treatment of moderate to severe Parkinson’s disease. With that approval, ISCO has begun enrolling patients for those phase I clinical trials in what marks a major milestone for the company.

International Stem Cell Corporation is researching new ways to increase the quality and length of human life spans through regenerative technologies that augment or replace organ transplants, developments made possible by the discovery of the structure of deoxyribonucleic acid (DNA) in 1953 by American biologist James Watson and English physicist Francis Crick. DNA was first identified (http://dtn.fm/Elyc9) by the Swiss physiological chemist Friedrich Miescher in 1869. The knowledge that the DNA molecule exists in the form of a three-dimensional double helix has been hailed as one of the ‘two radical developments over the past sixty years’ in medicine in What Happened to the Future (http://dtn.fm/FqxA9), a lament on the slow pace of present technological development.

The What Happened to the Future jeremiad penned by the venture capitalist Bruce Gibney while at Founders Fund tells how it used to be. ‘Less than twenty-five years after Watson and Crick published the structure of DNA, venture capitalist Robert Swanson and biochemist Herbert Boyer founded Genentech, now a subsidiary of Roche (OTCQX: RHHBY), which went on to synthesize insulin far faster and more cheaply than almost anyone believed possible. And in a great revolution in the FDA approval process in the 1980s following pressure from the AIDS lobby, the agency acted almost nimbly to approve a huge number of important new drugs for many maladies.’

However, since then the drug development process has become notoriously tortuous and costly. It starts with drug discovery, when new insights into how a disease progresses allow researchers to design a product to stop or reverse its effects. Alternatively, a number of molecular compounds may be tested to determine what effect, if any, they may have against a range of medical conditions. Sometimes, good fortune may come of the ubiquitous side effects. A drug prescribed for one condition may be found to have benefits in other areas. And then, of course, there are the new technologies like ISCO’s human parthenogenetic stem cell (hpSC) technology.

After a particular compound has been identified, it must be subjected to pre-clinical trials. Pre-clinical trials, or, as they are sometimes called, non-clinical testing, may be pharmacodynamic (examining what the drug does to the body); pharmacokinetic (examining what the body does to the drug); may examine how the compound is absorbed, distributed, metabolized and excreted by the body; or may attempt to determine its toxicity. In some instances, animals may be employed in pre-clinical trials.

It is only after greater knowledge of the compound has been obtained through pre-clinical testing that it will be administered to humans in clinical trials. Clinical trials typically may have four phases, each of which is designed to answer a research question. In phase I, researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects. This is the point that ISCO has reached with its human parthenogenetic stem cell ISC-hpNSC® technology.

In phase II clinical trials, the compound is given to a larger group of people to see if it is effective and to further evaluate its safety. In phase III studies, the drug is administered to an even larger group of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely. Phase IV testing is conducted after the drug has been marketed to gather information on the drug’s effect in various populations and any side effects associated with long-term use.

Before a drug can be marketed, it will be reviewed by the FDA when the sponsoring company submits a new drug application (NDA). And for many years to come, the FDA will continue its post-market safety monitoring. It’s quite a journey for a drug discovery company to take, but mindful of Gibney’s complaint, International Stem Cell Corporation is forging ahead with the phase I trials, which will be performed at the Royal Melbourne Hospital in Australia.

For more information, visit www.internationalstemcell.com

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International Stem Cell Corporation (ISCO) Pushing Forward with Regenerative Therapies

May 4, 2016

There is scant doubt that International Stem Cell Corporation’s (OTCQB: ISCO) attention and energy have been focused on creating advances in the field of regenerative medicine. On the contrary, ISCO continues to break new ground in settings where cells are being considered for use or are already being used in research and therapy. ISCO’s development and application of parthenogenesis, an impressive new stem cell technology, is a clear case in point.

Parthenogenesis is a stem cell development process that tackles the problem of immune-rejection. The process uses unfertilized human eggs to create a new class of specialized, pluripotent human stem cells better known as human parthenogenetic stem cells (hpSCs). ISCO’s research and development team has been using these stem cells to make important breakthroughs in the treatment of several diseases, especially in instances where cellular replacement has been shown to be clinically effective but there are no practical sources of safe, ethical cells with which to treat patients. HpSCs are ideal in such situations, because they have been designed so that they can be immune-matched to millions of people. They also have many of the advantages typically linked to embryonic stem cells without most of the ethical issues. Furthermore, a small fraction of hpSC lines can provide more than enough immune-matched cells for a large fraction of the world’s population.

ISCO’s scientists have been assessing the use of hpSCs for the treatment of Parkinson’s disease and other therapeutic indications, based on the company’s stem cell technology platform. For instance, they are striving to bring a stroke program into clinical trial using ISC-hpNSC and also developing a therapy for osteoarthritis that uses the applicable patient’s own cells. All of these initiatives are multi-year research and development efforts.

To garner income now, ISCO operates two successful business units, Lifeline Cell Technology and Lifeline Skin Care. For years, ISCO has been developing these wholly-owned subsidiaries so that they, in turn, can develop therapeutic products from its own intellectual property. Through Lifeline Skin Care and Lifeline Cell Technology, ISCO has been generating income from the sale of products that were designed using the company’s scientific discoveries. These products embody practical, short-term applications of ISCO’s larger human cell research capabilities.

At its cosmeceutical business, Lifeline Skin Care, ISCO’s employees have been developing, manufacturing and marketing cosmetic skin care products using a proprietary extract derived from the company’s pluripotent stem cells. At its research products business, Lifeline Cell Technology, the team has been creating, manufacturing and marketing human cell culture products, including frozen human “primary” cells and the reagents needed to grow, maintain and differentiate them.

In an effort to maintain its forward momentum, ISCO has been using its scientific discoveries to achieve both immediate and future goals. On the one hand, the company has used its discoveries to create products currently being sold by its two successful, revenue-generating subsidiaries. On the other hand, ISCO also intends to use its discoveries to develop breakthrough treatments for a number of worrisome health conditions and diseases.

For more information, visit www.internationalstemcell.com

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International Stem Cell Corporation (ISCO) Continues Upward Climb with Two Successful Subsidiaries

April 27, 2016

A pioneer in regenerative medicine, International Stem Cell Corporation (OTCQB: ISCO) strives to make a difference with its stem cell technology called parthenogenesis. The biotechnology company uses unfertilized eggs to create pluripotent human parthenogenetic stem cells (hPSC). These stem cells have the power to turn into any cell, healing and replacing aged or damaged cells. The possible indications for this technology range from cellular treatment point to a breakthrough for the treatments of degenerative diseases of the eye, nervous system, and liver. ISCO’s research and development team strongly believe in the effectiveness of their stem cell solution in such diseases as Parkinson’s, Corneal Blindness, and Ischemic Stroke. However, completing the proper testing and sanctions necessary to commercialize the company’s technology will take many years. In the meantime, ISCO derives substantial revenue from its two subsidiaries: Lifeline Skin Care Inc. and Lifeline Cell Technology, LLC.

Lifeline Skin Care Inc.(www.lifelineskincare.com) focuses on developing and marketing anti-aging products using ISCO’s breakthrough stem cell technology. The cosmetic company uses stem cells from unfertilized eggs to create solutions that reverse aging, add elasticity, and improve damaged skin cells. First, proteins are captured from these eggs and encased in micro nanospheres for protection. Antioxidants, vitamins, and minerals are then added for extra rejuvenation. Lifeline Skin Care’s products boost collagen production for even, firm skin. Retailers like Amazon (NASDAQ: AMZN), cosmetic surgery offices, spas, and international corporations sell these products, which adds more revenue streams and exposure for ISCO.

ISCO’s other subsidiary, Lifeline Cell Technology, LLC. (www.lifelinecelltech.com), develops and commercializes human cell culture products. Academic, pharmaceutical, and government laboratories purchase these products, such as frozen human cells and the material need for cultivation, for disease testing and study. Lifeline Cell Technology offers epithelial, hematopoietic, bladder, breast, kidney cells and more with the highest guaranteed quality. According to the company, these cells will “out-perform any other cells” out there.

Though ISCO eagerly waits for its proprietary parthenogenesis technology to gain global allowance, the company effectively uses its two subsidiaries for a steady revenue stream. The operating income for both companies increased 65% to $1.67 million in 2015, with 2014 having $1.01 million. Lifeline Skin Care retained steady numbers while Lifeline Cell Technology sales were up 15%. Overall, ISCO saw an 8% increase last year, as compared to 2014. The company intends to continue using its scientific breakthroughs and products toward contributing to regenerative medicine.

For more information, visit www.internationalstemcell.com

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International Stem Cell Corporation (ISCO) plans a Mutiny in Organ Transplant with its Immune-Matched hpSCs

April 20, 2016

It is generally accepted that the first successful organ transplant was the one performed by Dr. Joseph E. Murray at Peter Bent Brigham Hospital in Boston in 1954. Dr. Murray, who won the Nobel Prize for Medicine in 1990, and his team transplanted a kidney from one identical twin to another. Later, in 1967, Dr. Christian Bernard, a South African heart surgeon, garnered international acclaim after he performed the first human heart transplant at Groote Schur Hospital in Cape Town. Since then, the field of organ transplantation has grown. Data (http://dtn.fm/QMlg0) published by the U.S. Department of Health & Human Services, shows that ‘each day, an average of 79 people receive organ transplants’. Some estimates (http://dtn.fm/OgPb3) are even higher. The Musculoskeletal Transplant Foundation (MTF) states ‘it is estimated that approximately 600,000 Americans benefit from some form of transplant each year ’.

Yet the same U.S. government data shows that is not enough to satisfy the need and so ‘an average of 22 people die each day waiting for transplants that can’t take place because of the shortage of donated organs’. This is why professionals in the health care industry are increasingly turning to companies like the International Stem Cell Corporation (OTCQB: ISCO) and their regenerative technologies that augment or replace organ transplants.

The International Stem Cell Corporation’s human parthenogenetic stem cell (hpSC) technology holds out a life-saving promise to those with end-stage organ failure in two ways. First, it circumvents the problem that arises when the immune system attempts to reject the transplanted organ, which it perceives as an alien thing. In early transplant operations, medications were administered to suppress the immune system, but such an approach leaves the body, essentially, defenseless against other even minor threats.

The rejection problem arises because embryonic stem cells (hESCs) are heterozygous. i.e., they generally have different forms of genes (alleles) at each genetic position of the paternal and maternal chromosomes. Alleles contain the mechanism that determines between domestic and foreign bodies in the form of human leukocyte antigen (HLA) genes. ‘Since hESCs are derived from fertilized embryos, they carry the genes of a unique individual, thus the therapeutic cells derived from hESCs will carry alleles that can be recognized as foreign and be rejected by most patients unless they receive immunosuppressive therapy. Such therapy is costly, has significant side effects, and often is disabling in the long term.’

‘In contrast, the hpSCs developed by ISCO are derived from unfertilized eggs (oocytes) that have been shown in peer-reviewed journals to exhibit unlimited proliferation potential and are pluripotent (can become cells from all three germ layers that form a human being). Most significantly, hpSCs can be created in a ‘homozygous’ state in which the alleles, including the HLA alleles, are the same at each genetic position. When these HLA alleles are also found with a high frequency in a population, these ‘HLA-homozygous’ stem cells and their therapeutic derivatives have the potential to be immune-matched to millions of people. For example, ISCO’s first homozygous stem cell line with high-frequency HLA alleles has the potential to be immune-matched to an estimated 75 million people worldwide.’

Back in 2010, ISCO added two world-leading immuno-geneticists to its scientific advisory board to study the immune-matching properties of its human parthenogenetic stem cell technology and the potential for each hpSC-derived therapeutic cell to be an immune match for millions of people. Dr. Hans-Dieter Volk, Professor of Immunology and Chair of the Institute of Medical Immunology and Berlin-Brandenburg Center for Regenerative Therapies (BCRT) at Charité Universitätsmedizin in Berlin, and Dr. Matthias von Herrath, Professor at the La Jolla Institute of Allergy and Immunology at University of San Diego, are both highly regarded immuno-genetics experts internationally.

Second, hpSCs may obviate the need for an organ transplant. ISCO’s hpSCs are similar to human embryonic stem cells in that they have the potential to be differentiated into many different cells in the human body. Thus, they may replace diseased or malfunctioning cells in the liver, the eye, and in the nervous system before a full transplant operation is required.

For more information, visit www.internationalstemcell.com

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International Stem Cell Corporation (ISCO) Leads while Regenerative Medicine Becomes a Global Interest

April 13, 2016

A publicly-traded biotech company, International Stem Cell Corporation (OTCQB: ISCO) focuses its efforts toward developing innovative solutions that advance the field of regenerative medicine. This field strives to create functional tissue to repair and replace tissue or organs that have lost their function due to damage, disease, age, and congenital defects. ISCO has contributed to regenerative science by developing its own novel stem cell technology called parthenogenesis, which uses unfertilized eggs and addresses immune-rejection among humans. Stem cells have the potential to divide and differentiate themselves into any cell type. This means that these cells can treat degenerative diseases of the eye, nervous system, and liver through rebuilding and regeneration. Technological advancement in tissue engineering and stem cell therapy is expected to drive the global market for regenerative medicine.

Parthenogenesis uniquely studies immune-rejection, cell differentiation, and DNA patterns. ISCO’s technology creates a whole new class of stem cells called human parthenogenetic stem cells (hpSC). These are created by stimulating the oocytes (unfertilized eggs) into dividing. Different oocyte activation techniques create either heterozygous human parthenogenetic stem cell lines or homozygous human parthenogenetic stem cell lines. The former cells are only compatible with their donors, while the latter could be compatible with a large portion of the population. To maximize this innovative technology, the company developed the first collection of non-embryonic histocompatible (human compatible) stem cells used for research or commercial purposes. ISCO’s cell lines have the possibility of treating millions of people around the world.

Immune-matching, histocompatible cells have the potential of treating and even preventing diseases worldwide. For example, cancer is thought to come from abnormal cell proliferation and differentiation. Using stem cells, scientists can map out the human development of cells to see how cancer starts while also discovering treatments and prevention. Other diseases like Alzheimer’s and Parkinson’s could be treated using healthy cells to replace damaged ones. This is an exciting time for stem cell research because of the positive impact it could have around the globe.

To showcase increasing interest in their groundbreaking developments, ISCO recently announced that negotiations between two healthcare institutes and the company’s management have begun surrounding private placement of $6.3 million of the company’s convertible preferred stock and common stock purchase warrants to purchase $25.7 million of the company’s common stock. With exposure and interest surrounding regenerative medicine steadily increasing worldwide, ISCO is strongly poised to further its scientific studies as successful contributors in the field.

For more information, visit www.internationalstemcell.com

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International Stem Cell Corporation (ISCO) has a Place in the SAGE Encyclopedia of Stem Cell Research

April 7, 2016

The entry on International Stem Cell Corporation (OTCQB: ISCO) in the SAGE Encyclopedia tells a bit of the company’s story. At first, the researchers at ISCO were working on finding a stem cell treatment for diabetes, but ‘in the process (they) discovered parthenogenetic stem cells.’ ‘Today, ISCO is focused on using human parthenogenetic stem cells (hpSCs) to develop clinical applications to treat diseases of the liver, nervous system and eye.’ ISCO’s hpSCs are similar to human embryonic stem cells (hESCs) in that they have the potential to be differentiated into many different cells in the human body. The derivation of hpSCs does not, however, require the use of fertilized eggs or the destruction of viable human embryos and so avoids many of the controversies and ethical quandaries surrounding stem cell research. HpSCs also offer the potential for the creation of immune-matched cells and tissues that are less likely to be rejected following transplantation. Scientists at ISCO have been able to create the first parthenogenetic homozygous stem cell line that can be a source of therapeutic cells with minimal immune rejection after transplantation.

It may appear as a sign of weakness that ISCO started out looking for a diabetes treatment but is now focusing on Parkinson’s disease and other areas, but that is actually a sign of strength because it signals the company is driven by a management team that is versatile and adaptive. An insightful article in Bioentrepreneur with the eye-catching title ‘Six secrets to success — how to build a sustainable biotech business’ (http://dtn.fm/TuX3j) talks, first, about the importance of ‘having a strong, experienced and stable management team’ and ‘investing in the people at the top rather than the assets, technology or product.’ Its second takeaway is adaptability. ‘One of the main reasons biotech companies fail is because they believe they have the best potential drug and that the world will adapt to accommodate their business… (but) very few companies got their drug right the first time… the majority of the world’s top biotech companies are very different today compared with their formative years.’

International Stem Cell Corporation is certainly adaptive and strong on the first factor as well. Its entry in the SAGE Encyclopedia makes mention of its CEO, Andrey Semechkin, PhD, and his son, Russell Kern, PhD. Dr. Andrey Semechkin is a member of the Russian Academy of Sciences and has been deputy director of the Institute of System Analysis since 2004. Professor Semechkin was awarded a Russian Government Award in Science and Technology in 2006. He is the author of several scientific papers. In 2012, for example, ‘Derivation of high-purity definitive endoderm from human parthenogenetic stem cells using an in vitro analog of the primitive streak’ (http://dtn.fm/lqr3J) was published, which discussed the potential of hpSCs as sources for cell-based therapies and their advantage over hESCs on histocompatibilty issues. Semechkin has over 20 years’ experience creating and managing businesses across different industries and scientific sectors.

Mahnaz Ebrahimi is the chief financial officer at ISCO. She has over 25 years’ experience in executive and senior level positions in financial management, accounting and SEC reporting matters, and has worked with numerous publicly traded and privately held biotechnology, life science, and technology companies. Prior to joining ISCO, she served as a consultant to the company as well as to Flux Power Holdings, Polaris Pharmaceutical, and Ocera Therapeutics. From October 2010 to July 2012, Ebrahimi served as director, financial planning and analysis and treasury at eBioscience, where she was instrumental in the successful merger with Affymatrix in June 2012.

Russell Kern, PhD is the executive vice president and chief scientific officer at ISCO. Dr. Kern was trained in medical genetics, stem cell biology and international business administration, and holds an M.S. degree from the Faculty of Fundamental Medicine of Moscow State University. He earned his PhD in Physiology from Anokhin Research Institute of Normal Physiology, Russian Academy of Medical Sciences. Kern is a well-known speaker on stem cell biology, including the use of stem cells for neurology and skin regeneration. He has publications in the field of clinical and molecular biology, and is the author of various patent applications.

Sofya Bakalova, J.D., is vice president, legal affairs & operations at ISCO. Bakalova received her law degree from the University of Miami’s School of Law and has experience in various aspects of corporate and biotechnology law, regulatory affairs, project management, and business operations. After joining ISCO in March 2011, she has held a variety of business and legal roles, including in-house counsel, advisor to the CEO, and vice chairman of the board of directors for Lifeline Skin Care. Bakalova holds a bachelor’s degree in economics from San Francisco State University and has worked in the banking and finance industries prior to beginning her legal career.

For more information, visit www.internationalstemcell.com

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International Stem Cell Corp. (ISCO) Bypasses the Moral Dilemma Associated with Stem Cells

April 1, 2016

Human embryonic stem cells typically come from fertilized eggs. International Stem Cell Corp. (OTCQB: ISCO) uses a process called parthenogenesis, in which researchers use chemicals to induce the egg to begin developing as if it had been fertilized. The egg — called a parthenote — behaves just like an embryo in the early stages of division. Because it contains no genetic material from a father, however, it cannot develop into a viable fetus. Just like embryonic stem cells, parthenogenetic stem cells can be coaxed to grow into different kinds of human cells or tissue, ready to be transplanted into diseased areas of the body. International Stem Cell Corp. scientists have converted them into liver cells and plan to convert them into neurons for treating Parkinson’s disease, pancreatic cells for diabetes, and other tissues.

International Stem Cell Corp. is conducting a current study in which 12 people with moderate to severe Parkinson’s disease will be treated at Royal Melbourne Hospital in Melbourne. They will be given one of three doses of cells, from 30 million to 70 million. They will be monitored for 12 months to evaluate the safety and activity of these cells. The patients will be assessed before receiving the treatment under standards such as the Unified Parkinson’s Disease Rating Scale and will be reassessed at intervals.

Here are some startling statistics from the Parkinson’s Disease Foundation’s website (http://dtn.fm/t4Jyi). As many as one million Americans live with Parkinson’s disease, which is more than the combined number of people diagnosed with multiple sclerosis, muscular dystrophy and Lou Gehrig’s disease. Approximately 60,000 Americans are diagnosed with Parkinson’s disease each year, and this number does not reflect the thousands of cases that go undetected. An estimated seven to 10 million people worldwide are living with Parkinson’s disease. Incidence of Parkinson’s increases with age, but an estimated four percent of people with PD are diagnosed before the age of 50. Men are one and a half times more likely to have Parkinson’s than women.

The combined direct and indirect cost of Parkinson’s, including treatment, social security payments and lost income from inability to work, is estimated to be nearly $25 billion per year in the U.S. alone. Medication costs for an individual person with PD average $2,500 a year, and therapeutic surgery can cost up to $100,000 dollars per patient.

For more information, visit www.internationalstemcell.com

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International Stem Cell Corporation (ISCO) Offers Business Update and Year-End Financial Results

March 31, 2016

Before the opening bell, International Stem Cell Corporation (OTCQB: ISCO) provided a business update and announced its fourth quarter and year-end financial results for the period ended December 31, 2015. Through wholly-owned subsidiaries Lifeline Skin Care and Lifeline Cell Technology, the company increased its operating income by 65 percent to $1.67 million during 2015, as compared to $1.01 million in 2014. This increase, which also included an eight percent rise in total revenues, was attributed to a 15 percent spike in sales through Lifeline Cell Technology. Lifeline Cell Technology is expected to continue gaining momentum in the months to come following the recent launch of its new nano-compound products, which have been shown to induce the production of elastin and collagen without the toxic characteristics of retinoic acid.

This strong financial performance set the stage for ISCO’s progress toward the development of its innovative human parthenogenetic stem cells-derived neural stem cells, as described by its CEO and co-chairman, Andrey Semechkin, PhD.

“2015 was a milestone year for ISCO,” he stated in the news release. “We made significant progress in our corporate priorities and received authorization by the Therapeutics Goods Administration in Australia to initiate a Phase I dose escalation clinical trial of human parthenogenetic stem cells-derived neural stem cells (ISC-hpNSC®) in patients with moderate to severe Parkinson’s disease (PD). In addition to Parkinson’s, our scientists are currently evaluating other therapeutic indications based on our stem cell technology platform.”

After receiving approval to begin clinical trials of ISC-hpNSC for the treatment of Parkinson’s in Australia, ISCO entered into a master clinical research agreement with the Florey Institute of Neuroscience and Mental Health, one of the world’s leading brain research centers, covering a phase I clinical study. With this arrangement in place, the company commenced enrollment for its clinical trial in early March, and it expects to provide interim results from the study as early as October 2016.

ISCO will look to build on its recent progress moving forward in 2016. In addition to completing dosing in its phase I clinical study and reporting preliminary efficacy and safety clinical trial results, the company aims to report on the results of animal studies examining the efficacy of ISC-hpNSC as a treatment for stroke, as well as animal study results of a novel therapy using a patient’s own cells to combat osteoarthritis.

For more information, visit www.internationalstemcell.com

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International Stem Cell Corporation (ISCO) Developing Therapeutic and Biomedical Products on a Global Scale

March 24, 2016

International Stem Cell Corporation (OTCQB: ISCO) is a company focused on the therapeutic applications of human parthenogenetic stem cells (hpSCs) and the development of cell-based research and cosmetic products leading to commercialization. ISCO’s core technology, parthenogenesis, is achieved through the creation of pluripotent human stem cells from unfertilized oocytes (eggs). hpSCs avoid the 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 both genders and all ages and racial background with minimal risk of immune rejection after transplantation. hpSCs deliver the potential to create the first true stem cell bank, UniStemCell™.

The company’s resolve to be a leader in the field of restorative medicine is seen in its partnership with The Florey Institute of Neuroscience and Mental Health, a globally-recognized brain research center. The agreement drives both parties to launch phase I/IIa clinical trials on the effects of human parthenogenetic stem cells in individuals living with Parkinson’s disease (PD).

The Florey Institute’s credibility is undeniable. The institute employs a staff of over 500, with its scientists comprising the largest neuroscience research team in Australia. Work is conducted on a range of serious diseases, including epilepsy, stroke, PD, Alzheimer’s, traumatic brain and spinal cord injury, multiple sclerosis, depression, Huntington’s disease, motor neuron disease, schizophrenia, mental illness and a variety of addictions.

ISCO’s human cell culture products are made up of adult stem cells and reagents for regenerative medicine integral in the study of human renal and bladder diseases and prostate disease, as well as human corneal cells present in corneal disease and other cell culture reagents and supplements for the growth and freezing of human cells. International Stem Cell Corp. promotes and sells skincare products through its website and distribution channels and human cell culture products through its sales force, OEM partners, and brand distributors. The company is headquartered in Carlsbad, California, and was founded in 2001.

For more information, visit www.internationalstemcell.com

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International Stem Cell Corp.’s (ISCO) Virgin Birth Technology holds the Promise of Stemming Progress of Parkinson’s Disease

March 17, 2016

We are apt to scoff at stories of virgin birth, and the term itself is something of an oxymoron, since the virgin usually has had some ‘knowledge’ of a male progenitor. Many of the classical Greco-Roman heroes, like Hercules, who were the product of a virgin birth, were fathered by gods, as was the Christ, according to Christian dogma. But virgin birth or, at least, reproduction that takes place in the absence of fertilization, called parthenogenesis, occurs in nature all the time, both in plants (e.g. roses and orange trees) and animals (some kinds of ants, bees and wasps). Now, researchers have discovered ways of engendering parthenogenesis in mammals.

Early work on stem cells involved human embryos and, consequently, gave rise to ethical debate and controversy that threatened further research efforts. But in a ground-breaking paper titled ‘Nonhuman Primate Parthenogenetic Stem Cells’ (http://dtn.fm/3aP4i), published in 2003, Kent Vrana et al, wrote about their stem cell work using monkeys and reported that ‘stem cells were created via parthenogenetic activation of eggs’. This use of non-human cells provided a route out of the moral dilemma. Then, building on the insights of Vrana and his colleagues, a team at the privately-held Stemron Corporation of Rockville, Maryland, led by David Wininger reported in ‘Human Embryonic Stem Cell Lines Derived from Discarded Embryos’ (http://dtn.fm/o8ZcS) that it had ‘grown parthenogenetic human embryos to the blastocyst stage at which stem cells can be obtained’ and that ‘cells taken from one of the embryos survived for a few days’.

An April 2003 story in New Scientist titled ‘Virgin birth method promises ethical stem cells’ (http://dtn.fm/e2eWb), commenting on the Wininger breakthroughs, discusses how this is possible. Unfertilized eggs have two complete sets of chromosomes and during fertilization one set is discarded. ‘But an electric or chemical shock can make the egg develop as if fertilized and retain the extra set’. In parthenogenesis, an unfertilized egg keeps two sets of chromosomes and begins developing as if it had been fertilized and thus ‘produces embryos that could never become human beings’. The destruction of ‘these embryos to obtain stem cells would avoid the ethical concerns that have led to restrictions or bans on embryonic stem cell research in many countries.’

One area involving stem cells that shows remarkable promise is in the treatment of Parkinson’s disease. According to the Harvard Stem Cell Institute HSCI), Parkinson’s is ‘associated with the death of cells in a part of the brain… which produces the neurotransmitter dopamine’. Researchers at the HSCI have ‘orchestrated the transformation by biologically reprogramming the mature skin cells into induced pluripotent stem cells, and then encouraging the stem cells to become dopaminergic neurons. Neurons were also made from skin cells collected from individuals with genetic mutations associated with high risk for Parkinson’s disease’.

International Stem Cell Corporation’s (OTCQB: ISCO) UniStemCell for Parkinson’s has completed the Food & Drug Administration’s (FDA) Investigational New Drug (IND) phase, and the company announced recently that it had received authorization to initiate a phase I/IIa clinical trial of human parthenogenetic stem cells-derived neural stem cells (ISC-hpNSC) for the treatment of Parkinson’s Disease.

The phase I/IIa clinical study, which will be performed at the Royal Melbourne Hospital in Melbourne, Australia, is a dose escalation safety and preliminary efficacy study of 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 30,000,000 to 70,000,000 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. PET scans will be performed at baseline, as part of the screening assessment, and at 6 and 12 months after surgical intervention. Clinical responses compared to baseline after the administration of ISC-hpNSC will be evaluated using various neurological assessments.

In announcing the study, Russell Kern, PhD, ISCO’s executive vice president and chief scientific officer commented, “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”

This is welcome news. As the Harvard Stem Cell Institute reminds us: ‘Approximately one to two percent of the population over the age of sixty receives a diagnosis of Parkinson’s disease, although scientists believe that may be a very conservative estimate (and) at least one million Americans are currently known to be living with the condition.’

For more information, visit www.internationalstemcell.com

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International Stem Cell Corporation’s (ISCO) Mission to Treat Parkinson’s Disease Coming into Focus

March 10, 2016

International Stem Cell Corporation (OTCQB: ISCO) builds shareholder value through its research with stem cells, otherwise known as cells that can both proliferate (divide) and change (differentiate) into more specialized cells, such as skin, nerve or liver cells. The most powerful stem cells are known as ‘pluripotent’, as they have the promise of becoming virtually any cell in the human body. The first pluripotent stem cells to be studied were embryonic stem cells (ESC) taken from donated human embryos. ISCO’s new class of pluripotent human stem cells are derived from unfertilized eggs. These stem cells, known as human parthenogenetic stem cells (hPSC) avoid the ethical issues associated with ESC while retaining many of the advantages.

The company’s work does not begin and end with research. International Stem Cell Corporation’s primary goal is to transform its research into treatment for those suffering with moderate to severe Parkinson’s disease, and if recent developments are any indication of the company’s progress in this area, the recent announcement that enrollment has started for its upcoming phase I clinical trial should remove all doubt. The trial is scheduled to take place at the Royal Melbourne Hospital in Australia.

In a news release, Dr. Russell Kern, executive vice president and chief scientific officer of ISCO, recently noted, “Enrollment in this trial is an important milestone… Promising preclinical results support our expectation that ISC-hpNSC will bring a long-needed solution for patients suffering from Parkinson’s disease.”

ISCO is a publicly traded biotechnology company which developed a powerful new stem cell technology called parthenogenesis that could significantly advance the field of regenerative medicine by addressing the problem of immune-rejection. Parthenogenesis (from the Greek parthenos, meaning “virgin” and genesis, meaning “birth”) uses unfertilized human eggs to create hpSC that can be immune-matched to millions of people. A relatively small number of hpSC lines could provide sufficient immune-matched cells to cover a large percentage of the world’s population.

The company’s human cell culture products also comprise adult stem cells and reagents for regenerative medicine; human prostate cells and specialized media to study prostate disease; human renal and bladder cells and media to study renal and bladder diseases; human corneal cells and media for the study of corneal disease; and other cell culture reagents and supplements for the growth, staining, and freezing of human cells. International Stem Cell Corporation was founded in 2001 and is headquartered in Carlsbad, California.

For more information, visit www.internationalstemcell.com

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International Stem Cell Corporation (ISCO) Enters Definitive Agreement to Raise $6.3 Million to Fund Clinical Trial

Before the opening bell, International Stem Cell Corporation (OTCQB: ISCO) announced entry into a definitive agreement with two institutional healthcare investors and its management team through which the company will raise $6.3 million to fund its upcoming phase I study of human parthenogenetic neural stem cells (ISC-hpNSC). The agreement includes the initial purchase of $6.3 million of ISCO’s convertible preferred stock, in addition to common stock purchase warrants for an additional $25.7 million of the company’s common stock in the future. Through these efforts, the company is set to secure gross proceeds of $2.5 million in cash from the initial purchase, as well as conversion of $3.8 million of outstanding debt. The closing of this offering is expected to occur on or about March 15, 2016, subject to satisfaction of customary closing conditions, as described in the purchase agreement.

“The recurring investment of these healthcare focused institutional investors is in support of and attests to the potential of our technology,” Dr. Andrey Semechkin, co-chairman and chief executive officer of ISCO, stated in this morning’s news release. “The capital raised will help to drive our Phase 1 study of ISC-hpNSC® for the treatment of moderate to severe Parkinson’s disease.”

The announcement of this investment builds on what’s been a strong week for ISCO. On Monday, the company announced the commencement of enrollment for a phase I trial of its innovative ISC-hpNSC for the treatment of moderate to severe Parkinson’s disease after being granted approval by the Melbourne Health Human Research Ethics Committee. ISCO plans to initiate the study at Australia’s Royal Melbourne Hospital in the coming weeks, with management looking forward to preliminary clinical data as early as the fourth quarter of this year.

“With enrollment of patients already underway, we look forward to the end of this year for preliminary safety and efficacy clinical data,” Semechkin concluded.

ISCO’s powerful new stem cell technology, parthenogenesis, promises to significantly advance the field of regenerative medicine by addressing the problem of immune rejection. By utilizing unfertilized human eggs to derive parthenogenetic stem cells that can be immune-matched to millions of people, the company aims to enable treatment of a large percentage of the global population with a relatively small number of ISC-hpNSC lines. Through its phase I study of ISC-hpNSC for the treatment of Parkinson’s disease, the company is targeting a dramatically underserved neurodegenerative indication that directly affects more than seven million people around the world.

For more information, visit www.internationalstemcell.com

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International Stem Cell Corporation (ISCO) Commences Enrollment of Phase I Trial of ISC-hpNSC

March 7, 2016

Before the opening bell, International Stem Cell Corporation (OTCQB: ISCO) took a major step in the development of its human parthenogenetic stem cell-derived neural stem cells (ISC-hpNSC) for the treatment of moderate to severe Parkinson’s disease when it announced the commencement of enrollment for its upcoming phase I clinical trial. This announcement followed the Melbourne Health Human Research Ethics Committee’s (HREC) recent decision to grant approval of the phase I clinical trial in patients with moderate to severe Parkinson’s disease. The trial is scheduled to take place at the Royal Melbourne Hospital in Australia.

“Enrollment in this trial is an important milestone,” Dr. Russell Kern, executive vice president and chief scientific officer of ISCO, stated in this morning’s release. “Promising preclinical results support our expectation that ISC-hpNSC will bring a long-needed solution for patients suffering from Parkinson’s disease.”

Following completion of enrollment, ISCO will commence a dose escalation safety and preliminary efficacy study of its proprietary ISC-hpNSC. The clinical trial will involve intracranial transplantation of the stem cells into patients with moderate to severe Parkinson’s disease. A total of 12 patients are expected to participate in the trial, with three different dose regimens being studied. Following transplantation, the patients will be monitored at specified intervals for one year, with PET scans being performed as part of the screening assessment. The study’s submission will be overseen by Cyto Therapeutics Pty Ltd., a subsidiary of ISCO.

ISC-hpNSC have demonstrated promising results in preclinical studies. In both rodents and non-human primates, the highly pure stem cells have supported improvement in Parkinson’s symptoms and increases in brain dopamine levels. Additionally, ISC-hpNSC have been safe, well-tolerated and free from adverse side effects such as dyskinesia, systemic toxicity and tumors in preclinical models.

If approved, ISCO’s groundbreaking approach to the treatment of Parkinson’s disease could revolutionize an expansive treatment market. Currently, medications used to treat Parkinson’s, including L-DOPA and dopamine agonists, serve only to improve the early symptoms associated with the disease. As the illness progresses, the loss of dopaminergic neurons eventually renders these drugs ineffective while at the same time producing a complication marked by involuntary writhing movements. In recent years, incidence of Parkinson’s has been on the rise. In 2013, the disease resulted in roughly 103,000 deaths globally, up from about 44,000 deaths in 1990.

For more information, visit www.internationalstemcell.com

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International Stem Cell Corp. (ISCO): Benefits of Stem Cells Outlined in Israel/California Collaboration

March 3, 2016

In a recent article on the Jewish Journal website (http://dtn.fm/DhxK8), doctors, dignitaries and officials representing Israel and California convened at Cedars-Sinai Medical Center on February 8, 2016, to witness the signing of an agreement between Israel’s Ministry of Science and the California Institute for Regenerative Medicine (CIRM) to collaborate on stem cell research. It follows a 2014 Memorandum of Understanding to promote collaboration and innovation between Israel and California.

“Stem cell research is a cutting-edge field full of promise and opportunity. Who better to forge new ground together than the State of Israel and the State of California?” Israeli Minister of Science, Technology and Space Ofir Akunis said in the article. “Both are hotbeds of innovation, medical research and technological invention and have a strong commitment to science as a means to improve the lot of all humanity … creating a brighter future for us all.”

International Stem Cell Corp. (OTCQB: ISCO) specializes in the therapeutic applications of human stem cells and the development and commercialization of cell-based biomedical products. The company was the first to develop and perfect a new class of human stem cells called parthenogenetic stem cells, created from unfertilized human eggs. The company’s stem cells present superior immune matching capabilities and can be used in millions of people, regardless of sex or racial background, with minimal expectation of immune rejection after transplantation.

Stem cells are the future of medicine. Companies like International Stem Cell Corp. are on the front lines of this invaluable research, constantly looking for new ways stem cells can improve our quality of life by treating and eliminating diseases of the central nervous system (i.e. Parkinson’s disease), the liver, and the eye. The technology is getting better every day, and more people are coming around to at least giving it a look. The company has an ethical and moral purpose along with the potential to capitalize on a huge revenue stream.

The combined direct and indirect costs of Parkinson’s disease (PD), including treatment, social security payments and lost income from inability to work, is estimated to be nearly $25 billion per year in the U.S. alone. Medication costs for an individual person with PD average $2,500 a year, and therapeutic surgery can cost up to $100,000 dollars per patient.

For more information, visit www.internationalstemcell.com

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