Brainstorm Cell Therapeutics Inc (NASDAQ:BCLI)’s President and CEO Chaim Lebovits has issued a letter do the company’s shareholders highlighting some of the major events that shaped the just ended year, 2017.
According to Chaim, was generally successful for the company. The biggest success during the year was the enrollment of the first patient in the Phase 3 clinical study of NurOwn® used in amyotrophic lateral sclerosis (ALS) treatment. In addition to clinical success, the company also developed and improved its manufacturing capacity in several ways including validation of its cryopreservation process. Financially, the company was awarded additional non-dilutive grants by the California Institute for Regenerative Medicine (CIRM) and Israel Innovation Authority. Chaim said the company has further improved and strengthened its executive team by making new appointments.
In October, Brainstorm admitted its first patient in a randomized, double-blind, placebo-controlled multi-dose Phase 3 clinical trial of NurOwn® for the treatment of ALS. This Phase 3 trial is a build up on the impressive level of efficacy demonstrated in Phase 2.
Phase 3 trial, being the most advanced cell therapy in the development of treatment for ALS, enrolled around 200 patients and were spread out in six major clinical sites in the US. The trial will mainly focus on the sub-groups of patients which exhibited impressive results during Phase 2.
In the letter, the CEO says the company met and exceeded its expectations for the year in the sector of manufacturing and product development. The company is currently exploring strategic partnership so as to advance clinical development for NurOwn so as to maximize market potential. During the year, the company signed an MOU with Tel Aviv Sourasky Medical Center to explore the possibilities of availing NurOwn® to ALS patients under the MOH Hospital Exemption regulation provisions.
The year also saw the company expand its patent portfolio after being awarded and additional US patent for BrainStorm’s NurOwn® technology. This steps projects the company’s technology and is an outcome of the ongoing clinical successes and developments.
The company appointed Ralph Z. Kern, MD, MHSc as the new Chief Medical Officer and Chief Operating Officer. Additionally, it appointed Mary Kay Turner as the new Vice President of Patient Advocacy and Government Affairs. Eyal Rubin was appointed and joined the company as the new Chief Financial Officer in charge of corporate finance and accounting.
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