International Stem Cell Corp. (ISCO) Moves toward Commencement of Phase I Clinical Trial through Partnership with Cryoport

Earlier this week, Cryoport, Inc. (NASDAQ: CYRX), the world’s premier cryogenic logistics firm, announced a strategic partnership with International Stem Cell Corp. (OTCQB: ISCO) through which it will provide global logistics support for ISCO’s impending Phase I clinical trial of its human parthenogenetic stem cell-derived neural stem cells (ISC-hpNSC) for the treatment of moderate to severe Parkinson’s disease. Cryoport’s strategically located cryogenic facilities in Southern California and Singapore are expected to play a key role in ISCO’s efforts to maintain its cell therapy as it is transported around the globe to the study’s site, Australia’s Florey Institute of Neuroscience and Mental Health, which is one of the world’s foremost brain research centers.

“This trial will take place across the globe and it is imperative that our cell therapy maintains integrity,” Dr. Russell Kern, executive vice president and chief scientific officer of ISCO, stated in a news release. “We are pleased to have Cryoport handle our global logistics requirements.”

The partnership with Cryoport marks the latest in a collection of recent milestones related to ISCO’s highly-anticipated clinical program. After receiving authorization to initiate a Phase I/IIa clinical trial of ISC-hpNSC from the Therapeutics Goods Administration of Australia in December, the company quickly entered into a master clinical research agreement with the Florey weeks later. In March, ISCO announced its entry into definitive agreements for the private placement of $6.3 million of its convertible preferred stock, along with purchase warrants covering an additional $25.7 million of the company’s common stock, effectively strengthening its cash position in order to fund its Phase I trial. ISCO also commenced enrollment for the study in March, with preliminary clinical data expected as soon as the fourth quarter of this year.

Parkinson’s disease currently affects roughly 6.3 million people around the world, about 15 percent of whom develop the condition before reaching the age of 50, according to data from the European Parkinson’s Disease Association. Parkinson’s is caused by the degeneration of the substantia nigra portion of the brain, which is characterized by its dopaminergic neurons. When these neurons die, the brain becomes deprived of dopamine, resulting in symptoms such as tremors, rigidity and impaired balance. According to the National Parkinson Foundation, approximately 80 percent of all dopamine-producing cells are typically lost before the motor symptoms of Parkinson’s disease present themselves.

ISCO is taking aim at this devastating condition through the use of regenerative medicine. Through its proprietary ISC-hpNSC product candidate, the company is seeking to introduce a new approach to treating Parkinson’s that involves replacing the dead dopaminergic neurons with healthy neural cells while also protecting the brain by expressing neurotrophic factors. In preclinical testing, the candidate has been shown effective in both alleviating current symptoms and preventing further deterioration.

“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,” Dr. Andrey Semechkin, chief executive officer of ISCO, added in a news release.

For more information, visit www.internationalstemcell.com

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