NurOwn induces mesenchymal stem cells (MSCs) to secrete excessive ranges of neurotrophic elements (NTFs) recognized to advertise the survival of neurons and neuroprotection. The remedy has acquired Quick Observe standing from the U.S. FDA for ALS and has additionally been granted Orphan Drug Standing for ALS by each the FDA and the European Medicines Company. BrainStorm is presently finishing a 200-patient, double-blind, placebo-controlled, repeat-dosing NurOwn Part III examine within the U.S.
Catalent will undertake the switch of the manufacturing course of to, and supply future cGMP medical provide of NurOwn from its new, 32,000 sq.-ft. cell remedy manufacturing facility in Houston, TX. On completion of the medical trials and pending potential approval of NurOwn, the businesses might lengthen the partnership to incorporate business provide from the Houston facility.
“We’re proud to have a accomplice in Catalent whose excellence in manufacturing high quality therapies will help business provide of NurOwn,” mentioned Chaim Lebovits, Chief Government Officer of BrainStorm Cell Therapeutics. “We all know that ALS sufferers are in pressing want of a brand new therapy choice. If NurOwn is profitable within the present medical trials, this settlement will likely be integral to making sure fast entry for sufferers.”
Manja Boerman, Ph.D., President, Catalent Cell & Gene Remedy, mentioned, “Our expertise in cell remedy growth, and the manufacturing capabilities that our newly constructed, state-of-the-art facility in Houston provides, place us to greatest help BrainStorm, with its main therapeutic candidate for ALS therapy. We stay up for partnering with BrainStorm and offering our stem cell manufacturing experience as we work to optimize manufacturing and streamline the product’s path in direction of business launch.”