CARLSBAD, CA — (Marketwired) — 12/23/15 — International Stem Cell Corporation (OTCQB: ISCO) (www.internationalstemcell.com) a clinical stage biotechnology company developing novel stem cell-based therapies, announced today that it has entered into a master clinical research agreement with the Florey Institute of Neuroscience and Mental Health (Florey) 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. The Florey is one of the world’s leading brain research centers, employing the largest neuroscience research team in Australia.
Dr. Andrew Evans, M.D., director of the Movement Disorders Service at the Royal Melbourne Hospital will be the study’s principal investigator. Dr. Evans has published extensively on the disease particularly addressing symptoms that impact on the quality of life of sufferers and heads a number of clinical research trials. In addition to his research, 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,” commented Russell Kern, PhD, Executive Vice President, 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 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 are safe, well tolerated and do 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 pluripotent human 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 hundreds of 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-hpNSCs 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.
International Stem Cell Corporation
Russell A. Kern, PhD
Christopher R. Hippolyte
Tony Russo, Ph.D.
Phone: (212) 845-4251