International Stem Cell Corporation To Move Forward With Traumatic Brain Injury Phase II Clinical Trial
Published: Sep 20, 2017
CARLSBAD, Calif., Sept. 20, 2017 (GLOBE NEWSWIRE) -- International Stem Cell Corporation (OTCQB:ISCO) (www.internationalstemcell.com) ("ISCO" or "the Company"), a California-based clinical stage biotechnology company developing novel stem cell-based therapies and biomedical products, announced today that the completion of its preclinical studies in Traumatic Brain Injury (TBI) program will position it to commence a Phase II clinical trial in Australia under the Clinical Trial Notification scheme.
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“Often referred to as a silent epidemic, TBI represents a significant unmet medical need with millions affected annually. Based on the results of our proprietary ISC-hpNSC® demonstrated in our Parkinson’s disease clinical trial and in the preclinical studies conducted by the world-renowned academic collaborator, we believe ISC-hpNSC® can be an effective therapy for TBI” remarked Andrey Semechkin, PhD., Co-Chairman and CEO of ISCO.
"We are very impressed by the results of our TBI preclinical studies. Both motor and cognitive functions improved with neural stem cells ISC-hpNSC® transplantation without any safety issues,” commented Russell Kern, PhD., Executive Vice President and Chief Scientific Officer of ISCO. “With the clinical safety data collected in our Parkinson’s disease program, we are now ready to submit our regulatory application for a new clinical trial in another neurological indication. We are planning to evaluate the efficacy ISC-hpNSC® in a Phase II clinical study in patients with TBI and we will file a Clinical Trial Notification with the Australian TGA,” he continued.
ISCO's proprietary ISC-hpNSC® readily expandable neural stem cells significantly improve cognitive performance, locomotion, and neurological function in rodents with TBI. The preclinical studies were conducted by the world renowned Prof. Cesar Borlongan, Distinguished Professor who serves as the Vice Chairman for Research, Department of Neurosurgery and Brain Repair and as Director, Center of Excellence for Aging and Brain Repair at the University of South Florida Morsani College of Medicine. The results of these studies demonstrate the therapeutic potential of ISC-hpNSC® in TBI and should expedite its translation into the clinic.
There is currently no approved treatment for TBI. TBI is a leading cause of death and disability in the United States, contributing to approximately 30% of all injury deaths. According to the World Health Organization, the global incidence for TBI is approximately 10 million people annually.
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®. 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, progress of research and development initiatives, potential applications for ISC-hpNSC® 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.
International Stem Cell Corporation
Dr. Russell Kern
EVP, Chief Scientific Officer