Archive for the ‘International Stem Cell Corp. ISCO’ Category

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

Tuesday, July 8th, 2014

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

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

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

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

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

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International Stem Cell Corp. (ISCO) Firmly Rooted in Biotech Space with Innovative Technology, Unique Business Model

Monday, July 7th, 2014

International Stem Cell Corp., the developer of a new stem cell technology called parthenogenesis, is focused on the application of its research and development to the treatment of human degenerative diseases.

The company’s human parthenogenetic stem cells (hpSCs), derived from unfertilized human eggs, have the best characteristics of each of the most commonly used and described classes of stem cells – induced pluripotent stem cells, embryonic stem cells, and adult stem cells – thereby creating a class of cells that meet all important criteria when it comes to therapeutic application.

hsPCs’ are immune matching, which means that millions of patients could receive tissue and cell transplants without tissue rejection problems or the need to take immune-suppressing drugs; pluripotent, meaning they can change or “differentiate” into more specialized cells such as skin, liver or blood cells; demonstrate strong proliferation in culture, which refers to the growth of the cell populations in the research and/or application environment; and are considered superior in their use in genetic disease.

Leveraging these capabilities and characteristics, International Stem Cell aims to use its hsPCs to treat diseases of the brain (Parkinson’s diseases), liver (treatment of liver damage) and eye (cornea tissue implants). In support of these goals, the company is also building its stem cell bank (UniStemCell) of parthenogenetic stem cell lines for research and commercial use.

International Stem Cell’s subsidiary business units, Lifeline Cell Technology (LCT) and Lifeline Skin Care (LSC), further support the company and create a business model unique to the biotechnology industry, creating revenue flow from the sale of products develop from scientific discoveries made by International Stem Cell. This self-sustaining model not only allows for the allocation of revenues to further support scientific research and development, but also provides practical, short-term applications of the company’s core technologies.

For more information visit www.internationalstemcell.com

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International Stem Cell Corp. (ISCO) Advances Parkinson’s Program, Racing against Devastation of Disease

Monday, June 23rd, 2014

Approximately 8 million people have Parkinson’s disease worldwide, as many as 1 million of them Americans. Parkinson’s, caused by the degeneration of a small part of the brain and cells that make dopamine, is a progressively debilitating disease that affects the ability to control muscles and movement. Symptoms include tremors, rigidity of limbs or joints, loss or slowness of movement, impaired balance and coordination, and changes in speech.

There is currently no cure for Parkinson’s disease, and while modern treatments may improve symptoms, some may lose their effectiveness over time. Current treatments include oral medications; deep brain stimulation, which is limited to a sub-group of patients and has unknown long-term safety; and ethically controversial fetal tissue implants, which may result in immune rejection by the host body and graft-induced dyskinesia. Regardless of treatment, the disease continues to progress – the final stages of the disease often leaves the person wheelchair-bound, bedridden, and in need of a constant caregiver.

For International Stem Cell Corp., current treatments simply aren’t satisfactory. Using human parthenogenetic neural stem cells (hPNSC), a novel therapeutic cellular product derived from the company’s proprietary histocompatible human pluripotent stem cells, the company is rapidly advancing its alternative approach to treat Parkinson’s disease.

hPNSC’s are self-renewing multi-potent cells that are precursors for the major cells of the central nervous system. With their ability to differentiate into dopaminergic neurons and express factors that protect the nigrostriatal system, part of the brain that is particularly involved in the production of movement, hNSC’s offer a new opportunity for treatment of this neurological disease.

Following the plan devised with the Food and Drug Administration (FDA) at a pre-IND (investigational new drug) meeting earlier this year, International Stem Cell recently completed an acute toxicity study of its clinical drug candidate in rodent subjects. The results were positive, demonstrating that the doses that the company will be proposing to the FDA in its phase 1 clinical study are “well below the safety threshold.”

Despite stringent care and precautions, and without regard to the size of the enterprise, pharmaceutical and biotech companies face the risk of unforeseen regulatory issues that could slow down or even halt development of drug candidates. By achieving positive results in its latest toxicity study, International Stem Cell reached an important company milestone that will reduce some of these risks, strengthen the company’s IND submission and increase its chance for a positive review by the FDA.

In April, six months into the company’s pre-clinical non-human primate (NHP) clinical study, International Stem Cell reported behavioral improvements study subjects, suggesting that implanted cells may have a positive impact on disease symptoms. The most important result was that monkeys that were transplanted with stem cell-derived neuronal cells had higher levels of dopamine in the brain compared to the control group, which were transplanted with placebo.

Building on both of these studies and powerful proprietary stem cell-based technology, International Stem Cell continues to advance its program, racing against a disease expected to afflict 60,000 more people each year. The company is working with collaborators from Duke University and leading researchers around the world, and plans to file its IND in the second half of this year. Once the FDA reviews the submission, and assuming approval, International Stem Cell intends to move its Parkinson’s program to clinical phase within the next 12 months.

For more information, visit www.internationalstemcell.com

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International Stem Cell Corp. (ISCO) Makes Significant Advancement in Stem Cell Technology

Thursday, June 19th, 2014

International Stem Cell, a biotech company focused on the development and commercialization of stem cell-based research and cosmetic products, recently reported a significant advancement in human induced pluripotent stem cells (iPS) derivation with novel protein-based reprogramming method.

iPS cells are made by genetically reprogramming mature cells, which are usually taken from the skin, and can be used to create new cells of a different type. Original reprogramming methods utilize viruses to modify the cells genes and risk the inclusion of genetic material from the virus into the cells. These viral methods have proven extremely inefficient and can only produce limited quantities of cells.

ISCO’s biologists, however, have developed a fundamentally new method capable of enhancing the efficiency of the reprogramming process by using specific proteins called transducible transcription factors (TTF), while avoiding the use virus-based methods and the inherent risks associated with such methods.

The company’s new method demonstrates that its TTF-iPS technology has the ability to produce stable stem cells and is at least 10 times more efficient that older methods. In addition, the TTFs are naturally eliminated when no longer required, a characteristic that further improves safety.

“This new method offers a much needed safer and more efficient alternative to older techniques and represents a major step forward in being able to use iPS clinically,” Dr. Ruslan Semechkin, chief scientific officer for ISCO, stated in the news release. “We are currently working toward shortening the cell reprogramming step from around six weeks to as little as one week.”

For more information, visit www.internationalstemcell.com

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International Stem Cell Corp. (ISCO) Reports Positive Results of Parkinson’s Disease Study

Thursday, June 19th, 2014

International Stem Cell Corp., a California-based biotechnology company developing novel stem cell based therapies, just announced the completion of the acute toxicity study of its proposed clinical product to treat Parkinson’s disease. The recently completed IND-enabling study transplanting rodents with human neural stem cells, derived from ISCO’s proprietary parthenogenetic stem cell platform, showed that the cells are well tolerated even at high doses up to the equivalent of 2.2 billion cells in humans. The program continues to progress according to the plan outlined with the FDA at the pre-IND meeting as reported in February 2014. The company anticipates providing an update early next quarter.

“I’m pleased that we have successfully achieved another important milestone in our Parkinson’s disease program. A critical part of the development process, and the preparations for the IND submission, was to establish the highest tolerated dose of our clinical product in rodents,” stated Dr. Ruslan Semechkin, ISCO’s Chief Scientific Officer. “The results of this study show that the doses we will be proposing to the FDA in our phase I clinical study design for the treatment of Parkinson’s disease are well below the safety threshold.”

The study consisted of 19 immune deficient rodents divided into four cohorts, a control group and three treatment groups receiving escalating doses of human parthenogenetic neural stem cells (hPNSC). Animals received stereotactic injections of hPNSC in the striatum and substantia nigra. The rodents were observed for seven days post transplantation and demonstrated normal appearance and behaviors. Necropsies showed no abnormal tissues or tumors after sacrifice. Detailed immunohistochemical analysis demonstrated that the majority of the implanted cells survived the surgery and engrafted into the host brain tissue.

According to the Parkinson’s Disease Foundation, an estimated seven to 10 million people worldwide live with Parkinson’s disease, with as many as one million of those in the United States alone, more than the combined total of people diagnosed with multiple sclerosis, muscular dystrophy, and Lou Gehrig’s disease. The total direct and indirect cost of Parkinson’s disease is estimated to be nearly $25 billion per year in the United States alone.

ISCO’s Parkinson’s disease program uses human parthenogenetic neural stem cells (hPNSC), a novel therapeutic cellular product derived from the company’s proprietary histocompatible human pluripotent stem cells. hPNSC are self-renewing multipotent cells that are precursors for the major cells of the central nervous system. The ability of hPNSC to (i) differentiate into dopaminergic (DA) neurons and (ii) express neurotrophic factors such as glial derived neurotrophic factor (GDNF) and brain derived neurotrophic factor (BDNF) to protect the nigrostriatal system, offers a new opportunity for the treatment of Parkinson’s disease, especially in cases where current small molecule approaches fail to adequately control the symptoms.

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

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International Stem Cell Corporation’s (ISCO) VP to Present at BIO 2014

Tuesday, June 17th, 2014

International Stem Cell Corp., a California-based biotechnology company developing novel stem cell based therapies and biomedical products, announced today that Executive Vice President Dr. Simon Craw will present an overview of the company and its subsidiaries at the BIO 2014 conference on Tuesday, June 24th at 4:15 pm PDT. The San Diego Convention Center is hosting the conference in the Mission Beach room. For additional conference details go to: http://convention.bio.org.

Attracting approximately 15,000 of the most influential biotech and pharma participants from over 60 countries, BIO is the largest, most influential biotech meeting in the world. The convention is scheduled to include sessions and specialty forums covering 17 hot topics, over 1,700 exhibitors and BIO One-on-One Partnering™ meetings with thousands of companies from June 23 – 26th. Those interested in attending the conference and/or if you would like to schedule a meeting with ISCO’s management team, please contact the conference organizers. To register for the event visit the conference website at http://convention.bio.org/register.

ISCO’s work is centered on the therapeutic applications of human parthenogenetic stem cells (hpSCs) and the development and commercialization of cell-based research and cosmetic products. Parthenogenesis, the company’s core technology, results in the creation of pluripotent human stem cells from unfertilized oocytes (eggs) thereby avoiding ethical issues associated with the use or destruction of viable human embryos. Scientists at the company have created the first parthenogenetic, homozygous stem cell line that can be a source of therapeutic cells for hundreds of millions of individuals of differing genders, ages and racial background with minimal immune rejection after transplantation. The offerings of hpSCs possess the potential to create the first true stem cell bank, UniStemCell™. ISCO also produces and markets specialized cells and growth media for therapeutic research worldwide through its subsidiary Lifeline Cell Technology and stem cell-based skin care products through its subsidiary Lifeline Skin Care.

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

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International Stem Cell Corp. (ISCO): Moving Ahead with Parkinson’s Disease Program

Thursday, June 5th, 2014

International Stem Cell Corp., a biotechnology company, is focusing on developing novel stem cell-based therapies and biomedical products. The company recently declared its first quarter results; reporting year-over-year revenue growth of 28% to $1.65 million, with a gross margin of 73%. The revenue was mainly driven by the strong performance of its subsidiary, Lifeline Cell Technology, which contributed around 51% to the company’s total revenue.

On April 29, after six month of its trial study, the company reported significant behavioral improvement in its pre-clinical non-human primate (NHP) study of PD. The company spent around $958,000 on research and development (R&D) in the last quarter compared to $721,000 in same period last year. The increase in R&D was mainly driven by the increased stem cell line research and testing expenses. This helped the company to improve the efficacy of its drug to treat PD, which is based on its stem cell line technology.

Superior results from the pre-clinical study for treating PD

International Stem Cell, after six months observation of its pre-clinical non-human primate (NHP) study for PD, reported significant behavioral improvement in the PD cases. The company divided the total primates that have matching levels of Parkinsonism and functional disability into three groups. Out of these three groups, two received different doses of human neural stem cells (hPNSC) developed from ISCO’s proprietary parthenogenetic stem cell line “phSC-Hhom-4.” The company in initial experiments on mice demonstrated that the neuronal cells derived from this technology lived in mice brain without developing tumors. This shows that the company’s stem cell line technology has higher potential to provide improved graft acceptance and possible therapeutic applications, including treating PD.

International Stem Cell’s technology helped it to demonstrate healthy behavior scores (the intelligence quotient level of the individual) of the treated group, which were increased by 170% compared to just 58% in placebo group. The third group demonstrated a significant improvement in the main Parkinson’s rating score of 63% (p< 0.05) compared to minute improvement in the control group.

This significant change in the scores signifies a greater reduction in the severity of the symptoms in the treatment group compared with the control group. This is expected to lead to higher improvements in International Stem Cell’s trial studies. Further, as per the meeting with the FDA in February, the company plans to complete FDA-required pharmacology and safety studies by the end of 2014. The recommendations on the PD trial program from the FDA will allow the company to improve the efficacy of the drug. This could reduce the risk of the any delays and integrating the recommendation from the FDA in the program will enable the company to develop stronger Investigational New Drug (IND) applications with a greater chance of positive reviews.

Market opportunity in PD treatment

PD is the 14th leading cause of death in the U.S. Also notable, The Parkinson’s Disease Foundation estimates around seven million to ten million people are living with PD globally and around one million are in the U.S. alone. Further, around 60,000 new cases of PD are diagnosed annually in the U.S., and the total direct and indirect cost of PD is estimated to be around $25 billion per year. Medication costs for an individual suffering with PD is around $2,500 per year, and therapeutic surgery can cost $100,000 per patient.

The superior results demonstrated by International Stem Cell in the pre-clinical trial of its PD program and its efforts to improve the efficacy of its drug will enable the company to take advantage of the underlying opportunities in this PD medication market.

Conclusion

International Stem Cell with its “parthenogenetic stem cell line” technology will be able to improve the efficacy of its new drug candidates for treating PD. Further, fulfilling the FDA norm and integrating the FDA recommendation in its PD program will help to avoid the delays in submitting the IND application to FDA. The success of the PD program will generate greater opportunity in the PD medication market, which will in turn strengthen its long-term financial position.

For more information, visit www.internationalstemcell.com

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International Stem Cell Corp. (ISCO) Slated to Discuss Q1 Earnings – Revenues Up 28%

Tuesday, May 13th, 2014

International Stem Cell Corp., a California-based biotechnology company developing novel stem cell based therapies and biomedical products today provided a business update and announced financial results and for Q1 2014.

“Obtaining clarity from the FDA on our Parkinson’s disease program allows us to substantially lower the risk of unforeseen regulatory issues which could delay the program. By building the FDA’s feedback into our plans, we will be able to prepare a stronger IND submission with an increased chance of a positive review,” said Dr. Andrey Semechkin, the Company’s CEO and Co-Chairman.

“On the commercial side, on a year over year basis, top-line revenues have grown for seven consecutive quarters, confirming that our subsidiaries are executing on their business plans and are on the right track. Looking forward to the rest of 2014, we see no reason why this growth should not continue; although we expect our cash burn to increase compared with last year as we push to complete our pre-clinical work and IND submission,” concluded Dr. Semechkin.

Three Q1 2014 highlights included the holding of a pre-IND meeting with the U.S. Food and Drug Administration (FDA) clarifying the path to IND approval for ISCO’s novel neural stem cell treatment for Parkinson’s Disease (PD), the announcement of three months of positive data from the ongoing IND-enabling pharmacology/toxicology primate study demonstrating that a majority of the animals exhibit significant improvement in parkinsonism, including a return of many normal behaviors and a boost in revenues, up 28% year-over-year to $1.65 million for the three months ended March 31, 2014.

Revenue for the Q1 2014, totaled $1.65 million, compared to $1.29 million for the three months ended March 31, 2013 with LCT contributing $846,000 or 51% of total revenue for the three months ended March 31, 2014, compared to $635,000 or 49% for the three months ended March 31, 2013. LSC’s revenue of $803,000 for the three months ended March 31, 2014 accounted for 49% of total revenue, compared to $650,000 or 51% of total revenue for the three months ended March 31, 2013. Cost of sales for the same three months was $439,000 or 27% of revenue, compared to $334,000 or 26% of revenue for the three months ended March 31, 2013.

Research and development expenses were up 33% to $958,000 for the reported period in large part due to increased stem cell line research and testing expenses.

The company will be discussing their financial results for Q1 2014 in a conference call on Wednesday, May 14th at 11am EST. The company requests that participants dial in at least 10 minutes before the call to ensure timely participation. Dial in details are as follows:

Conference Number (U.S.): 1-877-941-2069
International Dial-In: 1-480-629-9713
Conference ID: 4682485
Webcast: http://public.viavid.com/confirmation/confirmwebcast.php?id=o5aroJyX

A playback of the call will be available from 05/14/14 at 5:00 pm ET until 05/28/14 at 11:59 pm ET. To listen, call 1-877-870-5176 within the United States or 1-858-384-5517 when calling internationally. Please use the replay pin number 4682485.

International Stem Cell Corporation is focused on the therapeutic applications of human parthenogenetic stem cells (hpSCs) and the development and commercialization of cell-based research and cosmetic products. ISCO’s core technology, parthenogenesis, results in the creation of pluripotent human stem cells from unfertilized oocytes (eggs). hpSCs avoid ethical issues associated with the use or destruction of viable human embryos.

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

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International Stem Cell Corp. (ISCO) Schedules Q1 2014 Business Update and Financial Results Conference Call

Thursday, May 8th, 2014

International Stem Cell Corp., a California-based biotechnology company developing novel stem cell based therapies and biomedical products, announced that it will host a conference call next with to provide a business update and discuss its financial results for the three months ended March 31, 2014.

Dr. Simon Craw, Executive Vice President, and Mr. Jay Novak, Chief Financial Officer of International Stem Cell, will be hosting the upcoming conference call. To attend the call, please use the dial in information below:

Date: Wednesday, May 14, 2014
Time: 11:00 a.m. Eastern Time
Conference Number (U.S.): 1-877-941-2069
International Dial-In: 1-480-629-9713
Conference ID: 4682485
Webcast: http://public.viavid.com/confirmation/confirmwebcast.php?id=o5aroJyX

Participants are advised to dial in at least 10 minutes before the call to ensure timely participation.

A playback of the call will be available from 05/14/14 at 5:00 pm ET until 05/28/14 at 11:59 pm ET. To listen, call 1-877-870-5176 within the United States or 1-858-384-5517 when calling internationally. Please use the replay pin number 4682485.

For more information, visit www.internationalstemcell.com

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International Stem Cell Corp. (ISCO) Study Reveals Promising Developments

Tuesday, April 29th, 2014

International Stem Cell Corp. announced today that behavioral improvements have been observed after six months in their pre-clinical non-human primate (NHP) study of Parkinson’s disease (PD). ISCO is a biotechnology company developing novel stem cell-based therapies and biomedical products and is based in Carlsbad, California. The detailed behavioral data is slated to be presented at the 66th American Academy of Neurology Annual Meeting in Philadelphia.

“It is encouraging to see these behavioral scores trending in the right direction as it means that the implanted cells may be having a positive impact on the disease symptoms,” said Professor D. Eugene Redmond Jr. MD, of Yale University Medical School and the study’s supervisor. “The rating scores are equivalent to components of the UPDRS which is widely used in research to evaluate Parkinson’s patients. The Parkison’s score is known to correlate very highly with brain dopamine concentrations.”

The study, consisting of 18 primates, are exposed to the neurotoxin, MPTP, divided into three cohorts, a sham treated group and two treatment groups receiving different doses of human neural stem cells (hPNSC) derived from ISCO’s proprietary parthenogenetic stem cell line. All groups had matching levels of parkinsonism and functional disability prior to the cell injections. Six months of data showed that the healthy behavior scores of the treatment group increased 170% while the placebo group increased by 58%. In addition, one treatment group showed a major improvement in the main Parkinson’s rating score of 63% (p < 0.05) while the control group exhibited no significant improvements.

According to the Parkinson's Disease Foundation, an estimated seven to 10 million people worldwide live with PD, with as many as one million of those in the United States alone, more than the combined total of people diagnosed with multiple sclerosis, muscular distrophy, and Lou Gehrig's disease. The total direct and indirect cost of Parkinson's disease is estimated to be nearly $25 billion per year in the United States alone.

Dr. Ruslan Semechkin ISCO's Chief Scientific Officer, commented: "The results of this interim analysis are very promising. This study provides information about how our human neural stem cells, derived from our parthenogenetic stem cells, behave in a diseased brain and how the diseased tissue responds and is a critical part of our planned IND submission."

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

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International Stem Cell Corp. (ISCO) CSO to Present at American Academy of Neurology Annual Meeting in Philadelphia

Tuesday, April 22nd, 2014

International Stem Cell Corp., a California-based biotechnology company focused on developing novel stem cell-based therapies and biomedical products, announced today that Dr. Ruslan Semechkin, ISCO’s Chief Scientific Officer, will present data from its pre-clinical primate studies of Parkinson’s disease at the 66th American Academy of Neurology Annual Meeting in Philadelphia. The meeting is scheduled for Tuesday, April 29, 2014, at 1:00 p.m. EST. The topic is ‘Movement Disorders’ and the Session title is ‘Parkinson’s disease: Preclinical and Clinical Therapeutics.’

The American Academy of Neurology Annual Meeting is known to be the world’s largest gathering of neurologists. The American Academy of Neurology is an association of more than 27,000 neurologists and neuroscience professionals who are dedicated to promoting the highest quality patient-centered neurologic care. Neurologist’s are doctors with specialized training in diagnosing, treating and managing disorders of the brain and nervous system such as Alzheimer’s disease, stroke, migraine, multiple sclerosis, concussion, Parkinson’s disease, and epilepsy.

ISCO’s work centers on the therapeutic applications of human parthenogenetic stem cells (hpSCs) and the development and commercialization of cell-based research and cosmetic products. The company’s core technology, parthenogenesis, results in the creation of pluripotent human stem cells from unfertilized oocytes (eggs) thereby avoiding ethical issues associated with the use or destruction of viable human embryos. Most notably, ISCO scientists have created the first parthenogenetic, homozygous stem cell line that can be a source of therapeutic cells for hundreds of millions of people of different genders, ages, and racial backgrounds with minimal immune rejection after transplantation. hpSCs provide the potential to create the first true stem cell bank, UniStemCell™. International Stem Cell also produces and markets specialized cells and growth media for therapeutic research around the world through its subsidiary Lifeline Cell Technology, and stem cell-based skin care products through its subsidiary Lifeline Skin Care.

The Parkinson’s Disease Foundation notes an estimated seven to 10 million people worldwide live with Parkinson’s disease, with as many as one million in the United States alone, more than the combined total of people diagnosed with multiple sclerosis, muscular distrophy, and Lou Gehrig’s disease. The total cost of Parkinson’s disease is estimated to be nearly $25 billion per year in the United States alone.

More information is available at www.internationalstemcell.com

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International Stem Cell Corp. (ISCO) Operating Subsidiary Signs Distribution Agreement

Tuesday, April 1st, 2014

International Stem Cell Corp. announced today that Lifeline Skin Care, its operating subsidiary, has signed a distribution agreement with Grupo Venta Internacional, S.A de C. V., Mexico’s largest distributor of aesthetic and reconstructive products. Grupo Venta Internacional will offer Lifeline’s breakthrough stem cell skin care products to health care professionals throughout Mexico, the second largest market for aesthetic skin care in Central and South America. The agreement is effective immediately. ISCO is a California-based biotechnology company developing novel stem cell-based therapies and biomedical products.

As reported by Euromonitor International, the Mexican skin care market is expected to be worth approximately $2 billion in 2014, citing anti-aging products as being among the most popular. With 24 years’ experience in the plastic surgery and dermatology market in Mexico, and the credibility and presence of their 85-person national sales force, Grupo Venta Internacional (GVI) is well qualified to help Lifeline become very successful in this growing market.

President of GVI, Gabriela Gonzalez Alonso commented, “Plastic surgeons and dermatologists in Mexico are very excited about the potential for stem cell skin care products. They’re already familiar with the benefits of growth factors for skin rejuvenation, but the concept of stem cells elevates the technology to a whole new level. A brand that is backed by a biotech company adds even more credibility.”

“Expanding international sales is a key part of our growth strategy,” said Donna Queen, President of Lifeline Skin Care. “Initially Lifeline will be marketed only to physicians, which will lend credibility to the brand. The recommendation of a trusted health care professional is consistently rated as one of the most important consideration when selecting anti-aging skincare products. For this reason we’re especially pleased to be working with Grupo Venta Internacional.”

Lifeline Skin Care works on developing, marketing, and selling advanced anti-aging skin care products based on technology patented by ISCO. The technology uses ingredients that have been extracted from ISCO’s human, parthenogenetic stem cells and are known to reduce the visible signs of skin aging. Over the last 18 months, Lifeline’s sales have grown on average by over 40% a quarter, on a year to year basis. Lifeline Skin Care is available from dermatologists, plastic surgeons, selected medical spas, and day spas.

International Stem Cell Corporation works on the therapeutic applications of human parthenogenetic stem cells (hpSCs) and the development and commercialization of cell-based research and cosmetic products. ISCO’s core technology, parthenogenesis, creates pluripotent human stem cells from unfertilized oocytes (eggs) and in so doing avoids ethical issues commonly associated with the use or destruction of viable human embryos. ISCO scientists have created the first parthenogenetic, homozygous stem cell line that can be a source of therapeutic cells for hundreds of millions of people of different genders, ages, and races with minimal immune rejection after transplantation. hpSCs offer the potential to create the first true stem cell bank, UniStemCell™.

For more information, visit www.internationalstemcell.com

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International Stem Cell Corp. (ISCO) Well-Positioned for Strong 2014

Friday, March 28th, 2014

In a recent shareholder update, ISCO’s Executive Vice President, Dr. Simon Craw drew attention to the company’s strong financial performance and clinical achievements in 2013. Craw said that these factors were strong indicators of where he expects ISCO to be headed in 2014.

For key indicators of company performance in 2013, Craw pointed to three indicators: ISCO’s growth of full-year revenue by 35 percent, successful cost containment, and achievement of a slew of research and development milestones that bode well for the future. For full-year performance, ISCO reported revenues of $6.15 million and a full-year net loss of $10.5 million ($0.09 per share), up from a full-year net loss of $9.8 million in 2012 ($0.013 per share). Notably, on the call ISCO’s CFO Jay Novak reinforced that the company’s careful cost control had kept the company from a more pronounced net loss in the face of its substantial research and development efforts.

In a business update issued in mid-March, Dr. Andrey Semechkin, company CEO and board Co-chairman, touched upon ISCO’s pre-IND meeting with the FDA for its Parkinson’s disease cell therapy, and its plans for completion of the FDA’s required pharmacology and safety studies by this year’s end. Afterward, he noted, ISCO plans to file the IND for the potentially groundbreaking therapeutic solution. For business plan execution, Semechkin said that ISCO was committed to growing its commercial subsidiaries while maintaining strong efforts toward cutting costs.

ISCO’s Parkinson’s disease program incorporates usage of human parthenogenetic neural stem cells (hPNSCs), which are derived from ISCO’s proprietary histocompatible human pluripotent stem cells (hpSCs). In the words of the company, this cutting-edge cellular product comprises “self-renewing multipotent cells that are precursors for the major cells of the central nervous system.” In laymen’s terms, the ability of hPNSC to be differentiated into key neurons, and to be expressed as key neurotrophic factors for protection of the nigrostriatal system of the human brain, offers strong potential for treatment of Parkinson’s disease.

At the heart of ISCO’s therapeutic application, development, and commercialization efforts is its core technology, parthenogenesis. The technology uses unfertilized human eggs, or oocytes, for creation of hpSCs. These stem cells are said to hold tremendous therapeutic potential for tens of millions of patients with severe diseases of the eye, nervous system, or liver.

For long-term market positioning, ISCO has adopted a novel business model for the biotech space. The company leverages business units that generate revenue from the sale of products developed from scientific discoveries made by its research team. Currently, ISCO leverages two subsidiaries, Lifeline Skin Care and Lifeline Cell Technology for self-sustainment of current R&D efforts and short-term, practical applications of its core technologies.

The Parkinson’s Disease Foundation says that 7-10 million people worldwide live with Parkinson’s disease. Around one million of these people live in just the United States; more than the combined amount of people diagnosed with multiple sclerosis, muscular distrophy, and Lou Gehrig’s disease. With ISCO’s Parkinson’s disease program on the rise, Parkinson’s disease patients may be given a groundbreaking answer to their affliction.

For more information, visit www.internationalstemcell.com

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International Stem Cell Corp. (ISCO): Strong 2013 Achievements, Financial Results Foster Optimism in 2014

Thursday, March 20th, 2014

International Stem Cell, a biotech company developing novel stem cell-based therapies and biomedical products, in conference call yesterday detailed its financial results and clinical achievements in the 12 months ended December 31, 2013, and offered insight into upcoming 2014 events.

“So, 2013 was a very good year for International Stem Cell Corporation,” Dr. Simon Craw, executive vice president of ISCO stated in the conference call. “We continue to execute on our business plans, growing revenues to over $6 million while containing costs, but also importantly achieving a number of R&D milestones that position us extremely well for 2014 and beyond.”

Briefly touching on the company’s research and development strategy, Dr. Craw noted the company’s primary focus on developing human parthenogenetic neural stem cells as a clinical product initially to treat Parkinson’s disease. The company is currently working on pre-requisite studies necessary to filing a New Drug Application with the U.S. FDA.

Dr. Craw recapped several 2013 company milestones regarding ongoing research and development, and with specific regard to its Parkinson’s disease program, said ISCO plans to complete FDA-required pharmacology and safety studies by the end of 2014 with the IND to shortly follow. The company also anticipates exploring and developing additional indications for its human neural stem cells.

Moving on to the company’s full-year financial performance, ISCO reported 2013 revenues of $6.15 million, an impressive increase of 35 percent compared to full-year 2012. Lifeline Skin Care sales increased 47 percent while Lifeline Cell Technology sales rose 24 percent. The two subsidiaries generated operating income in 2013 of $0.65 million compared to operating loss in 2012. Gross margin improved to 73 percent in 2013 compared to 72 percent a year ago.

Net loss for full-year 2013 was $10.5 million, or $0.09 per share, compared to a prior year loss of $9.8 million, or $0.013 per share. This reflects the $2.9 million impact of the company’s July financing transaction.

ISCO burned through $0.47 million per month through 2013, ending the 2013 with cash of $2.24 million.

“As Simon indicated, 2013 was a very successful year for the company. In 2013, we have made substantial progress in our R&D development efforts, all while keeping tight control of our cash burn,” said ISCO Chief Financial Officer Jay Novak.

Wrapping up the call, Dr. Craw emphasized advances in company research and development, and stated a reminder of what’s to come in the year ahead.

“I think everyone can see, in 2013 we made some important progress in our research and development activities, primarily in our Parkinson’s disease program where we achieved a number of critical milestones that move us closer to the clinic. In 2014, we’ll be endeavoring to complete our IND enabling studies and in order to file our first IND for this experimental treatment of Parkinson’s disease. At the same time, we continue to execute on our business plan, growing revenues in our commercial subsidiaries and containing cost,” he concluded.

For more information, visit www.internationalstemcell.com

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International Stem Cell Corp. (ISCO) Announces Fiscal Year 2013 Highlights

Tuesday, March 18th, 2014

International Stem Cell Corp., a California-based biotechnology company developing novel stem cell-based therapies and biomedical products, today offered a business update and announced fourth quarter and year-end financial results for the year ended December 31, 2013.

Among numerous highlights within the company’s business is its work with its Parkinson’s disease program. The company continues to execute on its plan to develop human parthenogenetic neural stem cells (hPNSC) as a clinical product candidate for the treatment of Parkinson’s disease (PD). ISCO has published what they term a ‘breakthrough method of manufacturing hPNSC,’ in Scientific Reports, a primary research publication from the publishers of Nature. ISCO also reported positive results demonstrating the safety and efficacy of hPNSC in both rodent and non-human primate models of PD, presenting the results at the American Academy of Neurology 65th Annual Meeting in San Diego, CA, the American Society of Gene and Cell Therapy meeting in Salt Lake City, UT and the American Neurological Association 2013 Annual Meeting in New Orleans, LA. Among other highlights include beginning the IND-enabling non-human primate pharmacology and toxicology GLP study under the supervision of Yale School of Medicine Professor, D. Eugene Redmond Jr. MD.

In February 2014 the company held a pre-IND meeting with the FDA and subsequently announced that it will be working to complete the FDA required pharmacology and safety studies by the end of 2014, and file the IND shortly thereafter. In 2014 ISCO will also be working toward bringing forward additional indications for hPNSC. One noteworthy research and development activity includes the announcement of a significant advancement in human induced pluripotent stem cells (iPS) derivation using a novel protein-based reprogramming method at the American Society of Gene and Cell Therapy meeting in Salt Lake City, UT.

Notable fiscal year 2013 financial highlights include $6.15 million in revenue for the year ended December 31, 2013, an increase of 35% compared to 2012, Lifeline Skin Care sales up 47% and Lifeline Cell Technology sales up 24%, gross margin improving to 73% in 2013 from 72% in 2012, subsidiaries generating operating income in 2013 of $0.65 million compared to operating loss in 2012 and an average net cash used in operating activities of $0.47 million per month for the twelve months ending December 31, 2013. The company ended 2013 with cash of $2.24 million.

“In 2013 ISCO made important progress in Research and Development, primarily in the Parkinson’s disease program, achieving a number of milestones that move us closer to the clinic. In 2014 we will be endeavoring to complete our IND-enabling studies in order to file our first IND for our new experimental treatment of PD,” stated Dr. Andrey Semechkin, ISCO’s CEO and Co-chairman. “At the same time we continue to execute on our business plan, growing revenues in our commercial subsidiaries while maintaining costs,” Dr. Semechkin concluded.

For more information, visit www.internationalstemcell.com

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International Stem Cell Corp. (ISCO) to Announce Results of 2013 Efforts

Thursday, March 13th, 2014

International Stem Cell Corporation announced today that management will host a conference call on Wednesday, March 19th to deliver a business update and discuss its financial results for the year ending December 31, 2013. Dr. Simon Craw, Executive Vice President, and Mr. Jay Novak, Chief Financial Officer, will host the conference call. To attend the call, please use the dial in information below:

Date: Wednesday, March 19, 2014
Time: 11:00 a.m. ET
Toll-free (US only): 1-877-941-1427
International: 1-480-629-9664
Conference ID: 4673819
Webcast: http://public.viavid.com/index.php?id=108263

The company asks that you dial in at least 10 minutes before the call start time to ensure timely participation. A playback of the call will be available from 03/19/14 at 2:00 pm Eastern Time to 04/02/14 at 11:59 pm EST.

Teleconference Replay Details:
Dial in: 1-858-384-5517
Conference ID: 4673819

International Stem Cell’s efforts revolve around therapeutic applications of human parthenogenetic stem cells (hpSCs) and the development and commercialization of cell-based research and cosmetic products. ISCO’s primary technology, parthenogenesis, results in the creation of pluripotent human stem cells from unfertilized oocytes (eggs) thereby avoiding ethical issues associated with the use or waste of viable human embryos.

Scientists at ISCO have developed the first parthenogenetic, homozygous stem cell line that can be a source of therapeutic cells for hundreds of millions of individuals with differing genders, racial background, and ages with minimal immune rejection after transplantation. hpSCs promise to create the first true stem cell bank, UniStemCell™. The company also produces and markets specialized cells and growth media for therapeutic research worldwide through its subsidiary Lifeline Cell Technology and stem cell-based skin care products through its subsidiary Lifeline Skin Care.

Among the company’s therapeutic programs is a treatment for Partinson’s disease using dopaminergic neurons, a treatment of lever disease with stem cell derived hepatocytes, a treatment of blindness with corneal tissue and stem cell bank development.

For more information, visit www.internationalstemcell.com

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Positive Data Fuels International Stem Cell Corp. (ISCO) Research

Tuesday, March 11th, 2014

International Stem Cell Corp. recently announced positive data results from the first interim analysis of the ongoing IND-enabling pharmacology/toxicology primate study conducted under the supervision of Professor D. Eugene Redmond Jr. MD, of Yale University Medical School. The company is a biotechnology company focused on therapeutic applications of human stem cells and the development and commercialization of cell-based biomedical products.

Professor Redmond commented, “The initial data from this large controlled study is very encouraging. In Parkinson’s disease research non-human primate data are considered the gold standard and are by far the best indicator of likely outcomes in humans.”

Many of the animal subjects in the study have shown remarkable improvement in parkinsonism, while many returned to normal behaviors. The study consisted of 18 primates that were divided into three groups – a control group and two treatment groups with the treatment groups receiving different doses of human neural stem cells (hPNSC) derived from ISCO’s proprietary parthenogenetic stem cell line.

The design of this study uses a highly validated and widely published non-human primate model of Parkinson’s disease. The symptoms of the disease are induced by the administration of a neurotoxin which selectively destroys the same type of neuron that is affected in the human condition. This results in the monkeys exhibiting all the classic symptoms of PD from akinesia, rigidity gait abnormalities to tremors, freezing, and fine motor coordination.

In a comment by Dr. Ruslan Semechkin, Chief Scientific Officer for the company, it was stated, “This pharm/tox primate study, together with our rodent tumorigenicity study, is fundamental for ISCO’s planned IND submission — which we believe will be the first IND in the world using pluripotent stem cell-derived therapeutic cells to treat Parkinson’s disease. We anticipate providing further updates on this study in the second and third quarters, to report the final results towards the end of 2014 and to file the IND soon thereafter.”

For more information, visit www.internationalstemcell.com

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International Stem Cell Corp. (ISCO) Reports Positive Interim Data from Primate Study Parkinson’s Disease Cell Therapy

Tuesday, March 4th, 2014

International Stem Cell Corp., a biotechnology company specializing in the therapeutic applications of human stem cells and the development and commercialization of cell-based biomedical products, today issued a press release announcing positive data from the first interim analysis of the ongoing IND-enabling pharmacology/toxicology primate study being conducted under the supervision of Professor D. Eugene Redmond Jr. MD, of Yale University Medical School.

“The initial data from this large controlled study is very encouraging,” stated Professor Redmond. “In Parkinson’s disease research non-human primate data are considered the gold standard and are by far the best indicator of likely outcomes in humans.”

Most of the animals in this ongoing study have shown significant improvement in parkinsonism, as well as returned to many normal behaviors. The study consist of 18 primates divided into three cohorts, a control group and two treatment groups with the treatment groups receiving different doses of human neural stem cells (hPNSC) derived from ISCO’s proprietary parthenogenetic stem cell line.

This study design uses an extremely well validated and widely published non-human primate model of Parkinson’s disease. The symptoms of the disease are induced by the administration of a neurotoxin which selectively destroys the same type of neuron that is affected in the human condition. This results in the monkeys exhibiting all the classic symptoms of PD from akinesia, rigidity gait abnormalities to tremors, freezing and fine motor coordination.

Dr. Ruslan Semechkin, Chief Scientific Officer for the Company, commented: “This pharm/tox primate study, together with our rodent tumorigenicity study, is fundamental for ISCO’s planned IND submission — which we believe will be the first IND in the world using pluripotent stem cell-derived therapeutic cells to treat Parkinson’s disease. We anticipate providing further updates on this study in the second and third quarters, to report the final results towards the end of 2014 and to file the IND soon thereafter.”

For more information, visit www.internationalstemcell.com

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International Stem Cell Corp. (ISCO) Presenting at 26th Annual ROTH Conference

Tuesday, February 25th, 2014

Today before the opening bell, International Stem Cell Corp. announced that it will be making an appearance at the 26th Annual Conference. The conference is taking place Sunday, March 9, 2014 through Wednesday, March 12, 2014 at the Ritz Carlton, Dana Point, CA.

At the conference, Dr. Simon Craw, Executive Vice President of International Stem Cell Corp., will be presenting a corporate overview of the company and its subsidiaries. Dr. Craw’s presentation will be taking place at 3:30 pm PDT on Monday, March 10, 2014 in the room Track 5. Salon 5.

As its website notes, the ROTH Conference features “presentations from hundreds of growth companies, Q&A sessions, expert panels, and thousands of management one-on-one/small group meetings”. The event is one of the largest of its kind in the United States today and connects investors with unique opportunities to engage with and gain insight into numerous growth companies across a multitude of sectors. These sectors include: Cleantech, Consumer & Retail, Energy & Industrial, Enterprise Software, Healthcare, Resources, Semiconductors & Electronics, Services and Technology, and Media. It is a by-invitation-only event.

As a California-based biotechnology company that develops novel stem cell-based therapies and biomedical products, International Stem Cell Corp. is focusing on the therapeutic applications of human parthenogenetic stem cells (hpSCs) and the development and commercialization of cell-based research and cosmetic products. The company’s core technology, parthenogenesis, creates pluripotent human stem cells from unfertilized eggs and is said to have tremendous therapeutic potential for diseases of the eye, the nervous system, and the liver.

More information about International Stem Cell Corp. and its efforts can be found at: www.internationalstemcell.com

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International Stem Cell Corp. (ISCO) Announces Completion of Pre-IND Meeting with FDA for Parkinson’s Disease Program

Tuesday, February 18th, 2014

Today before the opening bell, ISCO announced that it had completed a pre-investigational new drug meeting (pre-IND) with the US FDA, thereby completing its discussions with the administration about the company’s Parkinson’s disease cell therapy. The company received feedback and input from the FDA on its proposed pre-clinical plan, manufacturing approach, and clinical study design necessary to file the IND.

We’re pleased with the outcomes of the meeting with the FDA,” said Yale School of Medicine Professor D. Eugene Redmond Jr. MD, who is leading ISCO’s pharmacology/toxicology study. “The FDA’s feedback has provided clear direction for the remaining studies required for the IND.”

“As this will be the first IND for the Company, we’re pleased to have completed this critical milestone,” said Dr. Ruslan Semechkin, Chief Scientific Officer of ISCO. “Based on data from our pilot studies, along with the guidance from the FDA, we believe that we’re well positioned to successfully transition this program to the clinical stage.”

According to the Parkinson’s Disease Foundation, some 7-10 million people worldwide live with Parkinson’s disease. Around 1 million of these people live in the United States alone, more than the combined amount of people diagnosed with multiple sclerosis, muscular distrophy, and Lou Gehrig’s disease. Direct and indirect costs attributed to Parkinson’s disease within the United States are estimated to be nearly $25 billion per year.

With the pre-IND meeting complete, ISCO will be working toward completion of the Good Laboratory Practice pharmacology and safety studies, including tumorigenicity, toxicology, and tolerability, via use of the human parthenogenetic neural stem cell (hPNSC) product. From the wording in the company’s news release, this product is a “type of self-renewing multipotent cell that is a precursor for the major cells of the central nervous system.” Pre-clinical pilot studies in rodents and primates have shown that the product’s safety, tolerability, and therapeutic benefit. Unlike other stem cell therapies, ISCO’s hPNSC product can be delivered in a frozen state to hospitals and other healthcare provider centers. ISCO anticipates the release of interim primate data before the end of March 2014 and top-line final results from these GLP studies later in 2014. From there, it expects to file the IND soon thereafter.

A comprehensive description of ISCO’s hPNSC product and the GMP manufacturing method was published in early 2013 with Prof. Evan Y. Snyder, Director of Stem Cell Research Center at Sanford-Burnham Medical Research Institute.

For more information, visit: www.internationalstemcell.com

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International Stem Cell Corp. (ISCO) Gearing Up for Transformational 2014

Tuesday, February 4th, 2014

International Stem Cell Corp. is a publicly traded biotechnology company concentrating on the therapeutic applications of human parthenogenetic stem cells and the development and commercialization of cell-based research and cosmetic products. The company’s core technological platform, parthenogenesis, creates pluripotent human stem cells from unfertilized eggs. With treatment possibilities for patients with diseases of the eye, the nervous system, and the liver, parthenogenesis can take the field of regenerative medicine in a whole new direction. The technology has strong therapeutic potential for treating hundreds of millions of individuals whose treatability has been limited by a lack of available, safe immune-matched human cells.

Recently, International Stem Cell Corp.’s Board Co-Chairman and CEO, Andrey Semechkin PhD issued a letter to shareholders outlining the company’s R&D achievements in 2013 as well as its R&D goals for 2014. Among the company’s 2013 achievements were:

• A description of the company’s novel human neural stem cells for Parkinson’s disease featured in the March issue of Scientific Reports, a publication of one of the world’s leading scientific publishers
• Announcement in Q1 2013 of data showing that the neural stem cells provided positive benefit in a rodent model of Parkinson’s Disease
• Published and discussed rodent model results as well as the company’s first non-primate study at the 65th Annual Meeting of the American Academy of Neurology
• In August 2013, entered into master clinical research agreement with Duke University to conduct clinical trials in Parkinson’s Disease
• Demonstration of a new technology program’s ability to create stable stem cells, be at least ten times more efficient than older methods, and avoid the risks associated with methods based on viruses (This program aims to develop a new and more effective method of producing induced pluripotent stem cells. This new method both successfully enhances the efficiency of the reprogramming process using specific proteins called transducible transcription factors and avoids the use of viruses.)
• Demonstration of the company’s metabolic liver disease program therapeutic potential via results showing that hepatocyte-like cells, developed by the program, reduce toxin levels in the liver without causing any serious side effects or safety issues

Goals for 2014 were outlined as well:

• Pre-IND meeting with the FDA in Q1 2014 to review the company’s pre-clinical data, manufacturing protocols, and clinical study design for the company’s Parkinson’s Disease program
• Q1 2014 release of interim data from the company’s large-scale primate study began in 2013
• If the pre-IND and pre-clinical studies prove success, the company will file for its ND application for the treatment of Parkinson’s disease with neural stem cells in the second half of 2014
• Upon FDA review, assuming the submission receives approval the company intends to begin the first-in-man (FIM) Phase 1 clinical study for the Parkinson’s Disease program

Much more information, including more details on the milestones and objectives above, can be found in the shareholder letter here: http://www.internationalstemcell.com/2014_Shareholder_Letter

For more information regarding International Stem Cell Corp., visit: http://www.internationalstemcell.com

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International Stem Cell Corp. (ISCO): Changing the Field of Regenerative Medicine with Unique, Self-Sustaining Business Model

Tuesday, January 28th, 2014

International Stem Cell is focused on exploring and advancing the therapeutic applications of human stem cells as well as 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, parthenogenetic stem cells, created from unfertilized human eggs, and has established a strong patent portfolio offering clean intellectual property and freedom to operate.

Utilizing a strategy much different than the majority of other players in the biotech space, International Stem Cell generates revenues from its individual subsidiary business units that sell products developed from scientific discoveries made by International Stem Cell. Not only is this model self-sustaining with revenues used to support scientific research and development, it also provides practical, short-term applications of the core technologies.

The Lifeline Cell Technology (LCT) and Lifeline Skin Care (LSC) commercial businesses provide the foundation for International Stem Cell’s short-term application. For the six-months ended June 30, 2013, International Stem Cell reported revenues of $2.74 million, compared to revenues of $2.13 million for the prior year period. LCT contributed $1.38 million, up 30 percent year-over-year, while LSC contributed $1.36 million, an increase of 27 percent from the same period in 2012.

Therapeutic programs, including those addressing Parkinson’s disease, metabolic liver disease and corneal blindness, make up International Stem Cell’s medium-term applications. In regards to its Parkinson’s disease program, International Stem Cell has carried out several stem cell-based experiments and recently concluded its first pilot primate study with favorable results. In mid-2104, the company plans to submit to the U.S. FDA an investigational new drug (IND) application, and recently engaged Duke University as a partner to carry out the phase I clinical study of Parkinson’s disease in human subjects.

International Stem Cell’s long-term strategy is focused on therapeutic products, licensing revenue and the company’s stem cell bank, UniStemCell, the life science industry’s first collection of non-embryonic histocompatible human stem cells available for research and commercial use.

Each aspect of International Stem Cell’s business model is centered on the company’s proprietary stem cell technology. The company’s stem cells present superior immune matching capabilities and can be used in millions of people, regardless of their sex or racial background, with minimized expectation of immune rejection following transplantation.

For more information visit www.internationalstemcellcorp.com

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International Stem Cell Corp. (ISCO) Co-Chairman and CEO Issues Shareholder Letter

Tuesday, January 21st, 2014

Today before the opening bell, International Stem Cell Corp. reported that Co-Chairman of the Board and Chief Executive Officer Andrey Semechkin PhD has published an open letter to shareholders.

Dr. Semechkin’s letter provides an update on the stem cell company’s research and development accomplishments, future expectations and anticipated milestones, along with a discussion of ISCO’s expanded intellectual property portfolio and a summary of the company’s commercial and financial performance for the first nine months of 2013.

The full text of the letter can be found at http://www.internationalstemcell.com/2014_Shareholder_Letter

International Stem Cell Corp. 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. ISCO has a strong patent portfolio offering clean intellectual property and freedom to operate. 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.

For more information visit www.internationalstemcell.com

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International Stem Cell Corp. (ISCO) Continues Development of Stem Cell Bank to Support Therapeutic Programs

Thursday, January 16th, 2014

International Stem Cell Corp. was the first to develop and perfect a new class of human stem cells called parthenogenetic stem cells, which are 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.

Based on this stem cell technology, ISCO is currently focused on three key therapeutic programs to treat incurable diseases of the brain, liver, and cornea.

Parkinson’s disease is the second most prevalent neurodegenerative diseases, affecting approximately 4 percent of the population aged 50 years and older. Leveraging its key clinical research agreement with Duke University, ISCO is evaluating its stem cell-derived neural stem cells for the treatment of Parkinson’s disease. The company has coordinated a team of leading experts to develop techniques and designs as well as to provide guidance for the company’s investigational new drug (IND) submission for this indication. ISCO plans on submitting its IND to the FDA this year.

Chronic liver disease (including hepatitis C) is the third most common cause of death due to chronic diseases in persons 35 to 64 years old. Direct health care expenditures for chronic and acute liver disease in the U.S. alone range from $60 billion to more than $100 billion annually.
ISCO’s scientific team is developing superior methods to create pure populations of hepatocyte, the main tissue of the liver, that could be used in transplantation using HLA homozygous parthenogenetic stem cell lines to avoid the cells being immune rejected by the recipient’s body.

Approximately 10 million people in the world are blind due to corneal damage, representing a large unmet medical need, mostly in the developing world. Additionally, there is an opportunity to develop corneas as a research product for the drug testing market. Scientists at ISCO have developed and filed patents on a process that creates human corneal tissue from parthenogenetic stem cells. It is anticipated that this program will be commercialized through ISCO’s subsidiary in India in partnership with the Insight Bioventures, India.

Through continued enrollment of egg donors and ongoing optimization of its methodology for the creation of additional HLA homozygous lines, ISCO is expanding its bank of parthenogenetic stem cell lines, which are critical to the success of the company’s therapeutic programs.

For more information visit www.internationalstemcell.com

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International Stem Cell Corp. (ISCO) Presenting at Biotech Showcase 2014 Conference

Tuesday, January 7th, 2014

International Stem Cell Corporation announced it will be presenting at the Biotech Showcase 2014 Conference at the Parc 55 Wyndham Union Square Hotel in San Francisco, California. The conference will be taking place Monday, January 13, 2014 to Wednesday, January 15, 2014.

Dr. Simon Craw, Executive Vice President of International Stem Cell Corporation, will be presenting a corporate overview of the company and its subsidiaries. The presentation will be made in Room Mission II – Track C on Monday, January 13, 2014 at 9:30 am PST (Pacific Time).

More conference details can be found at: http://www.ebdgroup.com/bts/index.php

Event registration details can be found at: http://www.ebdgroup.com/bts/registration/index.php

International Stem Corporation is focusing its primary efforts on treatment of Parkinson’s disease. The company’s disease program taps into the medical power of human parthenogenetic neural stem cells for treatment. In the words of the company, these cells are “self-renewing mulitpotent cells that are precursors for the major cells of the central nervous system”. With their biological capabilities, they represent a strong next-generation opportunity for treatment of Parkinson’s disease.

For more information, visit www.internationalstemcell.com

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