Category Archives: International Stem Cell Corp. ISCO

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.

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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.

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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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International Stem Cell Corp. (ISCO) Building Value through Development of Therapeutics for Parkinson’s Disease

February 26, 2016

International Stem Cell Corp. (OTCQB: ISCO) is considered among industry experts as a leader and pioneer in the field of regenerative medicine as a result of its development of a new class of stem cells. These cells, known as human parthenogenetic stem cells (hpSCs), possess the best characteristics of each of the other classes of stem cells. These stem cells are created by way of chemically stimulating the oocytes (eggs) to begin division. The oocytes are not fertilized and no viable embryo is created or destroyed. The ethical advantage of derivation from unfertilized oocytes makes these stem cells a promising source for the cell-based therapeutics industry.

ISCO is a biotech company that funnels its endeavors toward the development of therapeutic and biomedical products on a global scale. The company’s products are based on human parthenogenetic stem cells, a proprietary type of pluripotent stem cells. Additionally, the company develops neural stem cells, which are commonly used in the treatment of Parkinson’s disease (PD) and a variety of other neurological disorders.

Studies on the amount of money spent annually on the treatment of PD are nothing short of stunning. It is estimated that the combined direct and indirect costs of PD in the U.S. – which include treatment, social security payments and lost income due to the patient’s inability to work – is in the range of $25 billion. Medication costs for an individual afflicted with this disease average $2,500 a year. Furthermore, The Parkinson’s Disease Foundation has estimated that therapeutic surgery can cost up to $100,000 per individual.

Caused by the death of dopamine-producing cells in a brain region called the substantia nigra, PD typically results in severely restricted movement. Today’s treatments focus primarily on replacing the lost dopamine, but these treatments eventually fail, as the dopamine-making cells continue to die. It is through this process that stem cell therapy is of particular interest. Stem cell research has the potential to positively impact the development of disease-modifying treatments for PD. Enormous progress has been made in the area of creating dopamine-producing cells from stem cells, while the development of new cell models of PD has created a promising area of stem cell research as a whole.

For more information, visit www.internationalstemcell.com

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International Stem Cell Corp. (ISCO) Provides Hope for Parkinson’s Patients with Ethical Stem Cell Development

February 17, 2016

Parkinson’s disease is caused by death of dopamine-producing cells in a brain region called the substantia nigra, which hampers movement. Current treatments focus primarily on replacing the lost dopamine, but these treatments eventually fail because the dopamine-making cells continue to die. For this reason, stem cell therapy is of interest. International Stem Cell Corporation (OTCQB: ISCO) is a biotechnology company that focuses on the development of therapeutic and biomedical products worldwide. The company’s products are based on human parthenogenetic stem cells, a proprietary type of pluripotent stem cells. International Stem Cell Corp. develops cell types, including neural stem cells, for the treatment of Parkinson’s disease and other neurological disorders.

Parkinson’s disease is a chronic and progressive movement disorder, meaning that symptoms continue and worsen over time. Nearly one million people in the U.S. are living with Parkinson’s disease. The cause is unknown, and although there is presently no cure, there are treatment options such as medication and surgery to manage its symptoms.

The amount of money that the U.S. and individuals spend each year on Parkinson’s disease is staggering. The combined direct and indirect costs of Parkinson’s disease – 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 Parkinson’s average $2,500 a year, and therapeutic surgery can cost up to $100,000 per individual, according to the Parkinson’s Disease Foundation’s website (http://dtn.fm/4uIwr).

Stem cell research has the potential to significantly impact the development of disease-modifying treatments for Parkinson’s disease, and considerable progress has been made toward creating dopamine-producing cells from stem cells. The development of new cell models of Parkinson’s disease is a particularly promising area of stem cell research, as the current lack of progressive, predictive models of Parkinson’s disease remains a major barrier to drug development.

International Stem Cell Corp. has pioneered development of a new class of stem cells – human parthenogenetic stem cells (hpSCs) – that has the best characteristics of each of the other classes of stem cells. These stem cells are created by chemically stimulating the oocytes (eggs) to begin division. The oocytes are not fertilized and no viable embryo is created or destroyed. The ethical advantage of derivation from unfertilized oocytes, combined with immunomatching advantages, makes these stem cells a very promising source for cell-based therapy.

For more information, visit www.internationalstemcell.com

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International Stem Cell Corp. (ISCO) Eyes Growth through Partnerships to Develop Therapeutic and Biomedical Products Worldwide

February 9, 2016

International Stem Cell Corp. (OTCQB: ISCO) builds shareholder value through the development of restorative medicine using stem cell technology. Through its innovative parthenogenesis technology, the company makes use of human stem cells from unfertilized oocytes (eggs), bypassing common ethical controversy that accompanies the destruction of the viable human embryo. Additionally, the company works with subsidiaries Lifeline Skin Technology and Lifeline Skin Care in the area of skin rejuvenation on a product that contains a nano-compound that facilitates the replenishment of the skin’s texture and elasticity.

Evidence of the company’s resolve to be a leader in the field of restorative medicine can be found in a recent partnership with The Florey Institute of Neuroscience and Mental Health, one of the world’s leading brain research centers. The agreement calls for the team to launch Phase I/IIa clinical trials research on the effects of human parthenogenetic stem cells in people with Parkinson’s disease.

The credibility The Florey Institute brings to ISCO’s mission to build shareholder value cannot be understated. The Florey Institute of Neuroscience and Mental Health is one of the world’s leading brain research centers, employing a staff of over 500. The center’s scientists comprise the largest neuroscience research team in Australia. Its work is conducted on a range of serious diseases, including stroke, epilepsy, Alzheimer’s disease, Parkinson’s disease, traumatic brain and spinal cord injury, depression, multiple sclerosis, Huntington’s disease, motor neuron disease, schizophrenia, mental illness and addiction. Further, The Florey is viewed by many as a world leader in imaging technology, stroke rehabilitation and epidemiological studies.

The company’s human cell culture products are made up of adult stem cells and reagents for regenerative medicine aiding in the study of prostate disease, human renal and bladder diseases, human corneal cells present in corneal disease and other cell culture reagents and supplements for the growth, staining, and freezing of human cells. ISCO markets and sells skincare products through its website, channel sales, distributors and human cell culture products through its sales force, OEM partners, and brand distributors. International Stem Cell Corp. 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) 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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