Brainstorm Cell Therapeutics Inc. (NASDAQ:BCLI) Files An 8-K Regulation FD Disclosure
Item 7.01
All information contained in thisItem 7.01 ofthis Form 8-K shall not be incorporated by reference into any filing of the Company, whether made before or after the date hereof, regardless of any general incorporation language in such filing, unless expressly incorporated by specific reference to such filing. The information in this Item 7.01 shall not be deemed to be “filed” for purposes of Section18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that section or Sections11 and 12(a)(2) of the Securities Act of 1933, as amended.
In 2017, the Company submitted an application in Israel that would allow amyotrophic lateral sclerosis (“ALS”) patient access to NurOwn® under the Hospital Exemption Pathway (“HE”). This application was recently approved by the Israeli Ministry of Health (“MOH”), as notified by our partner Tel Aviv Sourasky Medical Center (Ichilov), to support the treatment of 13 ALS patients with NurOwn®.
HE allows for advanced therapy medicinal products, such as NurOwn®, to be made available to a group of patients where there is a critical unmet need and an absence of effective therapeutic alternatives, as agreed upon by the MOH. To qualify for HE, several important criteria must be met, including: product preparation according to specific quality standards (equivalent to those for a licensed product); use in a qualified hospital setting; and administered under the exclusive responsibility of an experienced medical practitioner. The Helsinki Committee at Ichilov, which is composed of bioethicists and other leaders from the Scientific and Medical Community, determined the final inclusion and exclusion guidelines to support HE ALS patient access for NurOwn®. Helsinki is equivalent to the Institutional Review Board (IRB).
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.
