Brainstorm Cell Therapeutics Inc. (NASDAQ:BCLI) Files An 8-K Other EventsItem 8.01.Other Events.
On January 3, 2018, Brainstorm Cell Therapeutics Inc. (the “Company”) announced that it has received Good Manufacturing Practice (GMP) approval from the Israel Ministry of Health (MoH) for its Israeli contract manufacturing facility. The GMP certificate confirms the Company's manufacturing site compliance with Israeli GMPs which are recognized as equivalent with EU GMP. This approval advances the Company's application to the Israel MoH for the treatment of ALS patients in Israel for a fee, under the newly introduced Hospital Exemption regulation. The GMP certificate was granted after an inspection of the Company’s contract manufacturing facilities.
About Brainstorm Cell Therapeutics Inc. (NASDAQ:BCLI)
Brainstorm Cell Therapeutics Inc. is a biotechnology company. The Company is engaged in developing adult stem cell therapies for debilitating neurodegenerative disorders, such as Amyotrophic Lateral Sclerosis (ALS, also known as Lou Gehrig’s disease), Multiple Sclerosis (MS) and Parkinson’s disease (PD), among others. Its subsidiary, Brainstorm Cell Therapeutics Ltd. (the Israeli Subsidiary), holds rights to commercialize the technology, NurOwn. NurOwn is in clinical development for the treatment of ALS. The Company has completed over two clinical trials of NurOwn in patients with ALS at Hadassah Medical Center (Hadassah). The first study, a Phase I/II safety and efficacy study of NurOwn in ALS patients administered either intramuscularly or intrathecally. The Company conducted Phase IIa combined (intramuscular and intrathecal) treatment, dose-escalating trial. It had completed treatment of over 10 patients in its ALS Phase IIa NurOwn dose-escalating clinical trial.