Last month, International Stem Cell Corp. (OTCQB: ISCO) published the results of its 12-month pre-clinical, non-human primate study demonstrating the safety and efficacy of its proprietary human parthenogenetic stem cell-derived neural stem cells (ISC-hpNSC™). These findings highlighted the efficacy of transplanting ISC-hpNSC into non-human primates induced with moderate to severe clinical Parkinson’s disease symptoms, as well as serving as the basis of ISCO’s application to the Australian regulatory authorities to move forward with clinical trials, which was approved in mid-December.
“The publication of the data in the peer-reviewed and highly-respected journal, Cell Transplantation, brings to conclusion the preclinical stage of ISCO’s Parkinson’s disease program,” Russell Kern, Ph.D., chief scientific officer of ISCO, stated in a recent news release. “The data provides further evidence that parthenogenetic neural stem cells can be effective in treating the symptoms of Parkinson’s disease.”
In recent weeks, ISCO has looked to build on this progress through the commencement of a phase I clinical trial of ISC-hpNSC for the treatment of moderate to severe Parkinson’s disease. The company announced the start of enrollment for this trial in early March, and it expects to present preliminary clinical data from this study as early as the fourth quarter of this year.
ISCO has also continued to make strides from a financial standpoint. In the first quarter of 2016, the company announced entry into definitive agreements with two institutional healthcare investors and management for the private placement of $6.3 million of ISCO’s convertible preferred stock, as well as purchase warrants covering up to $25.7 million of common stock. When combined with the revenues generated from its two wholly-owned subsidiaries, both of which remain profitable according to first quarter operating results, ISCO is in a favorable financial position as it moves toward the start of its phase I clinical trial at Australia’s Royal Melbourne Hospital.
If clinical trials prove successful, ISC-hpNSC will address a currently underserved indication that affects more than seven million people worldwide. According to data from the Parkinson’s Disease Foundation, the combined direct and indirect costs associated with the management of Parkinson’s is estimated at $25 billion per year in the United States alone. Currently, medication costs for an individual living with the neurodegenerative disease average roughly $2,500 annually, despite the fact that there is no available cure.
“We are very pleased to start the first human study of ISC-hpNSC’s for the treatment of this debilitating disease,” Andrey Semechkin, Ph.D., chief executive officer of ISCO, stated in a news release late last year. “There is a large unmet medical need for new treatments that may halt or reverse the progression of Parkinson’s disease and we believe our human neural stem cells may fill this need for the millions of people with this disease.”
For more information, visit www.internationalstemcell.com
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