International Stem Cell Corporation Announces Positive Efficacy Results in Traumatic Brain Injury
CARLSBAD, Calif., Oct. 18, 2016 (GLOBE NEWSWIRE) — International Stem Cell Corporation (OTCQB:ISCO), a California-based clinical stage biotechnology company developing stem cell-based therapies and biomedical products, announced today that the company’s proprietary ISC-hpNSC® readily expandable neural stem cells improved cognitive performance and motor coordination in rodents with traumatic brain injury. The study was conducted by Distinguished Professor Cesar Borlongan, Vice-Chairman for Research Department of Neurosurgery and Brain Repair and Director of Center of Excellence for Aging and Brain Repair, University of South Florida Morsani College of Medicine.
“We are encouraged by the first look of the efficacy results of the study for the treatment of traumatic brain injury. This is an area in need for effective treatment options. As we continue to develop our stem cell treatment of Parkinson’s disease, we are poised to expand our platform and the promise of stem cells to traumatic brain injury. We are hopeful that we will be able to see these early, positive efficacy trends continue as the study progresses,” said Russell Kern, PhD., executive vice president and chief scientific officer of the company.
The study consisted of rodents with controlled cortical impact injury, an established model of traumatic brain injury model. The animals were divided into four cohorts, a vehicle control group and three treatment groups receiving ISC-hpNSC through different routes of administration. Animals receiving injections of ISC-hpNSC displayed the highest levels of improvements in cognitive performance and motor coordination compared to vehicle control treated animals. Animals transplanted with ISC-hpNSC showed improved test performance in just a few days after implantation.
There is currently no approved treatment for traumatic brain injury, which is known to cause long-term neurological disability; but transplantation of neural stem cells may improve some of the symptoms. ISCO’s new traumatic brain injury program will use the same cellular product (ISC-hpNSC) as our ongoing Parkinson’s disease program. There is significant overlap with the Parkinson’s disease program in the safety datasets and manufacturing methods that would be required to file a regulatory application to start clinical trials for traumatic brain injury, making it a logical follow-on indication to pursue. The cGMP manufactured master and working cell banks of ISC-hpNSC have been qualified and extensively tested for sterility, purity, identity and safety, making them readily available for the traumatic brain injury program and other therapeutic applications. The extensive safety preclinical studies conducted during the development of our Parkinson’s disease program show that ISC-hpNSC is safe and well tolerated at very high doses, supporting its use in other neurological indications.
Over 1.7 million people in North America suffer annually from traumatic brain injury, with associated medical costs exceeding $70 billion. According to the World Health Organization, the global incidence for traumatic brain injury is approximately 10 million people annually. According to the CDC, traumatic brain injury is a leading cause of death and disability in the United States, contributing to about 30% of all injury deaths. Every day, 138 people in the United States die from injuries that include traumatic brain injury and its effects include impaired thinking or memory, movement, sensation (e.g., vision or hearing), or emotional functioning (e.g., personality changes, depression). These issues not only affect individuals but can have lasting effects on families and communities.
About ISC-hpNSC ®
International Stem Cell Corporation’s proprietary ISC-hpNSC® consists of a highly pure population of neural stem cells derived from human parthenogenetic stem cells. ISC-hpNSC® is 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. Preclinical studies in rodents and non-human primates have shown improvement in Parkinson’s disease symptoms and increase in brain dopamine levels following the intracranial administration of ISC-hpNSC®. ISC-hpNSC® provides neurotrophic support and cell replacement to the dying dopaminergic neurons of the recipient PD brain. Additionally, ISC-hpNSC® is safe, well tolerated and does not cause adverse events such as dyskinesia, systemic toxicity or tumors in preclinical models. International Stem Cell Corporation believes that ISC-hpNSC® may have broad therapeutic applications for many neurological diseases affecting the brain, the spinal cord and the eye.
About International Stem Cell Corporation
International Stem Cell Corporation (ISCO) is focused on the therapeutic applications of human parthenogenetic stem cells (hpSCs) and the development and commercialization of cell-based research and cosmetic products. ISCO’s core technology, parthenogenesis, results in the creation of human pluripotent stem cells from unfertilized oocytes (eggs). hpSCs avoid ethical issues 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 millions of individuals of differing genders, ages and racial background with minimal immune rejection after transplantation. hpSCs offer the potential to create the first true stem cell bank, UniStemCell™. ISCO also produces and markets specialized cells and growth media for therapeutic research worldwide through its subsidiary Lifeline Cell Technology (www.lifelinecelltech.com), and stem cell-based skin care products through its subsidiary Lifeline Skin Care (www.lifelineskincare.com). More information is available at www.internationalstemcell.com.
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Safe harbor statement
Statements pertaining to anticipated developments, expected results and timing of clinical studies, potential applications of ISC-hpNSC® to other diseases, progress of research and development initiatives, and other opportunities for the company and its subsidiaries, along with other statements about the future expectations, beliefs, goals, plans, or prospects expressed by management constitute forward-looking statements. Any statements that are not historical fact (including, but not limited to statements that contain words such as “will,” “believes,” “plans,” “anticipates,” “expects,” “estimates,”) should also be considered to be forward-looking statements. Forward-looking statements involve risks and uncertainties, including, without limitation, risks inherent in the development and/or commercialization of potential products, regulatory approvals, need and ability to obtain future capital, application of capital resources among competing uses, and maintenance of intellectual property rights. Actual results may differ materially from the results anticipated in these forward-looking statements and as such should be evaluated together with the many uncertainties that affect the company’s business, particularly those mentioned in the cautionary statements found in the company’s Securities and Exchange Commission filings. The company disclaims any intent or obligation to update forward-looking statements.