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From: QualityStocks (Rep: 4)Date: 05/30/2013 11:59
Forum: International Stem Cell Corporation - Msg #117Thread #673531850 (Rec: 0)
International Stem Cell Corp. (ISCO) Initiates Final Step to File IND for Treatment of Parkinson’s Disease

International Stem Cell, a biotech company focused on developing novel stem cell-based therapies, has initiated its IND-enabling pharmacology and toxicology non-human primate studies directed by Yale School of Medicine Professor D. Eugene Redmond Jr. MD, an internationally recognized neurosurgeon and a leader in the use of stem cells for the treatment of Parkinson’s disease.

The studies will assess the safety and efficacy of ISCO’s proprietary stem cell-derived neuronal cells when administered to non-human primates with moderate to severe Parkinson’s disease symptoms. Established endpoints of these multi-dose studies are to determine cell fate, biodistribution, and primate behavioral evaluations using a standardized rating scale to assess potential extrapyramidal side effects associated with the cell engraftment.

In his career of more than 25 years, Professor Redmond has become a recognized expert in the use of transplanted neural cells to treat parkinsonism in primates and the development of effective replacement strategies using stem cell derived neurons. In addition, he has established one of the first preclinical models for Parkinson’s disease in primates, the first successful transplantation of fetal tissue into the brain of a primate, and one of the first clinical studies of fetal tissue in Parkinson’s patients.

Dr. Ruslan Semechkin, vice president of ISCO’s R&D, referenced positive data from the company’s recent, successful primate and rodent studies, and said that under the leadership and knowledge of Professor Redmond, the upcoming formal studies will be final step for ISCO to file an IND for Parkinson’s disease.

“As one of the leaders in this field, it’s tremendously exciting for ISCO to have such an experienced and influential clinical scientist as Prof. Redmond to direct this research. His clinical experience will be invaluable as we prepare both our IND submission to the FDA and the subsequent phase I clinical trial,” Dr. Semechkin stated in the press release.

ISCO expects interim results in the fourth quarter of 2013 with the final results available in the second quarter of 2014.

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