International Stem Cell Corp. (ISCO) Advances Parkinson’s Program, Racing against Devastation of Disease

Approximately 8 million people have Parkinson’s disease worldwide, as many as 1 million of them Americans. Parkinson’s, caused by the degeneration of a small part of the brain and cells that make dopamine, is a progressively debilitating disease that affects the ability to control muscles and movement. Symptoms include tremors, rigidity of limbs or joints, loss or slowness of movement, impaired balance and coordination, and changes in speech.

There is currently no cure for Parkinson’s disease, and while modern treatments may improve symptoms, some may lose their effectiveness over time. Current treatments include oral medications; deep brain stimulation, which is limited to a sub-group of patients and has unknown long-term safety; and ethically controversial fetal tissue implants, which may result in immune rejection by the host body and graft-induced dyskinesia. Regardless of treatment, the disease continues to progress – the final stages of the disease often leaves the person wheelchair-bound, bedridden, and in need of a constant caregiver.

For International Stem Cell Corp., current treatments simply aren’t satisfactory. Using human parthenogenetic neural stem cells (hPNSC), a novel therapeutic cellular product derived from the company’s proprietary histocompatible human pluripotent stem cells, the company is rapidly advancing its alternative approach to treat Parkinson’s disease.

hPNSC’s are self-renewing multi-potent cells that are precursors for the major cells of the central nervous system. With their ability to differentiate into dopaminergic neurons and express factors that protect the nigrostriatal system, part of the brain that is particularly involved in the production of movement, hNSC’s offer a new opportunity for treatment of this neurological disease.

Following the plan devised with the Food and Drug Administration (FDA) at a pre-IND (investigational new drug) meeting earlier this year, International Stem Cell recently completed an acute toxicity study of its clinical drug candidate in rodent subjects. The results were positive, demonstrating that the doses that the company will be proposing to the FDA in its phase 1 clinical study are “well below the safety threshold.”

Despite stringent care and precautions, and without regard to the size of the enterprise, pharmaceutical and biotech companies face the risk of unforeseen regulatory issues that could slow down or even halt development of drug candidates. By achieving positive results in its latest toxicity study, International Stem Cell reached an important company milestone that will reduce some of these risks, strengthen the company’s IND submission and increase its chance for a positive review by the FDA.

In April, six months into the company’s pre-clinical non-human primate (NHP) clinical study, International Stem Cell reported behavioral improvements study subjects, suggesting that implanted cells may have a positive impact on disease symptoms. The most important result was that monkeys that were transplanted with stem cell-derived neuronal cells had higher levels of dopamine in the brain compared to the control group, which were transplanted with placebo.

Building on both of these studies and powerful proprietary stem cell-based technology, International Stem Cell continues to advance its program, racing against a disease expected to afflict 60,000 more people each year. The company is working with collaborators from Duke University and leading researchers around the world, and plans to file its IND in the second half of this year. Once the FDA reviews the submission, and assuming approval, International Stem Cell intends to move its Parkinson’s program to clinical phase within the next 12 months.

For more information, visit www.internationalstemcell.com

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