CARLSBAD, CA–(Marketwired – November 03, 2015) – International Stem Cell Corporation (OTCQB: ISCO), a California-based biotechnology company developing novel stem cell-based therapies and biomedical products, announced today that after a recent meeting with Australian Therapeutics Goods Administration (TGA) the Company’s wholly owned subsidiary Cyto Therapeutics signed a Letter of Intent (LOI) with Royal Melbourne Hospital (Australia) to conduct phase I/IIa clinical trials of ISCO’s proprietary human parthenogenetic neural stem cells (hPNSCs) for the treatment of Parkinson’s Disease. Under this process, a full agreement will be signed after TGA and the HREC approve the clinical protocol for the phase I/IIa trials.
“We had a productive meeting with TGA where we discussed the clinical protocol and potentially came to an agreement on all remaining items. We look forward to receiving TGA approval for clinical trials in November and enrolling patients soon thereafter,” said Russell A. Kern, Ph.D., chief scientific officer of ISCO.
ISCO’s Parkinson’s disease program uses human parthenogenetic neural stem cells (hPNSC) which are a novel therapeutic cellular product derived from the Company’s proprietary 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 differentiate into dopaminergic neurons and express neurotrophic factors to protect the nigrostriatal system offers a potential new opportunity for the treatment of Parkinson’s disease.
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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Statements pertaining to anticipated developments, expected clinical studies (including timing and results of both the studies and regulatory approvals), 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