BrainStorm Cell Therapeutics Inc. has been gaining national recognition as a leading developer of adult stem cell technologies. Today, the company announced a major strategic agreement with Harlan Biotech Israel Ltd. (HBI) in order to complete pre-clinical safety experiments for the company’s innovative therapy for Amyotrophic Lateral Sclerosis (ALS), which is famously known as Lou Gehrig’s disease because it claimed the life of the famed baseball player.
This agreement will add to another agreement entered with PPS which was announced on August 31, 2009. Together, these agreements will allow the young company to complete the experiments required to submit an application to the Lelsinki Committee with the Israeli Ministry of Health for starting clinical trials for Lou Gehrig’s disease (ALS) in Israel.
Under the terms of the agreement with HBI, Harlan will perform pre-clinical safety experiments using the company’s cGMP compliant stem cells. The experiment will be performed immediately following production of the company’s cGMP compliant stem cells which is currently performed by Brainstorm’s scientists at PPS facilities. The production process is scheduled to extend over a period of several months, however the company has entered into the agreement with HBI in order to ensure that the necessary preparations are performed by HBI and that the safety experiments will commence at HBI without further delay. The company recently announced on August 24, 2009 that it has secured the funding needed to complete the pre-clinical safety experiments from the Israeli government’s Office of the Chief Scientist and from a private investor.
When asked about the impact of this agreement of BrainStorm, company CEO was quoted as saying, “We are pleased that a highly-experienced contractor with a track record of successfully conducting pre-clinical experiments according to FDA and Israeli Ministry of Health standards will be assisting us in the final stages of our ALS pre-clinical program. With this strategic agreement we have now completed the necessary arrangements required for performing the mandatory safety study to achieve our goal of reaching a human clinical trial in 2010.”
Dr. Nati Ezov, who serves as HBI’s CEO, stated, “HBI is proud to welcome the opportunity to extend its professional services to BrainStorm, as well as to all other local clients, and hereby expresses its appreciation to collaborate with BrainStorm on this most challenging project.”