India Clears Off-The-Shelf Stem Cell Therapy for Buerger's
Stempeutics Research has been granted limited approval to make and sell the first allogeneic cell therapy product for Buerger’s Disease in India. The stem cell therapy, which was granted orphan drug designation by the EMA last year, may hold potential in certain additional indications as well.
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A regular roundup of commercial stories appearing in Scrip's sister publication PharmAsia News, whose multilingual team of regional experts provides authoritative business intelligence on the Asian marketplace.
Pluristem Therapeutics chair and CEO Zami Aberman explains to Mike Ward, global director of content for Informa Pharma Insights how stem cell therapy will shape the industry. Using placental cells and a proprietary, three-dimensional (3D) technology platform, Pluristem is developing "off the shelf" cell therapies for a broad spectrum of diseases. Pluristem converts human placental stem cells into PLacental eXpanded (PLX) cells, which secrete therapeutic proteins in response to signals produced by damaged tissues. The company's pipeline targets multiple indications involving inflammation and ischemia, including peripheral artery disease, muscle injury, preeclampsia, and graft versus host disease. Aberman tells Mike Ward that his company intends to use the $17m it raised in 2015 to complete current clinical studies and start new ones.
Japan continues to attract interest in the area of regenerative medicine. Indian firm Stempeutics Research now says it is eyeing collaboration opportunities for its stem-cell based drug, Stempeucel, initially targeted for the treatment of critical limb ischemia.