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BrainStorms’s Cell Therapy receives Orphan Drug Designation in EU

Authored by James Sheppard

The Israel based biotechnology company, BrainStorm Cell Therapeutics, announced that the European Medicine Agency (EMA) had given Orphan Drug Designation to its lead asset NurOwn. NurOwn is a stem cell therapy consisting of autologous bone marrow-derived mesenchymal stromal cells secreting neurotrophic factors, for the treatment of Amyotrophic Lateral Sclerosis (ALS).

The ruling by the EMA follows NurOwn receiving Orphan Drug Designation by the US FDA in 2011. BrainStorm is currently conducting a phase IIa clinical study involving 12 ALS patients in Israel. Following successful completion of this study the company anticipates launching a phase II multi-centre study at three leading institutions in the US towards the end of 2013.

BrainStorm has received a great deal of interest in NurOwn and has recently received $725,000 from the Israeli government to develop the therapy. This investment comes on the back of a recent partnering deal BrainStorm completed with the world famous Dana-Fabre Cancer Institute in the USA. The partnership will allow for production of NurOwn in the USA to ensure that BrainStorm can successfully run its multi-centre phase IIa trial in the USA later this year.

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