BCLI collaborates with HBI to complete pre-clinical safety experiments

Sep 15 2009

BrainStorm Cell Therapeutics Inc. (OTCBB: BCLI), a leading developer of adult stem cell technologies and therapeutics, announced today that it has entered into a strategic agreement with Harlan Biotech Israel Ltd (HBI), a leading Good Laboratory Practice contractor, in order to complete pre-clinical safety experiments for the company’s innovative therapy for ALS (Amyotrophic Lateral Sclerosis, also known as Lou Gehrig’s disease).

This agreement, together with the agreement entered by Brainstorm with PPS, as announced on August 31, 2009.

Under the agreement with Harlan, HBI 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.

“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,” said Rami Efrati, CEO of BrainStorm Cell Therapeutics.

“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,” noted Dr Nati Ezov HBI’s CEO.

Harlan Biotech Israel (HBI), a subsidiary of the world-known globally-operating Harlan Laboratories Inc., is a leading local and fully Good Laboratory Practice-accredited and OECD- GLP-compliant pharmacological and toxicological contract research laboratory. HBI’s extensive experience with similar somatic-cell associated pre-clinical efficacy and safety studies will enable HBI to assist BrainStorm in optimizing the pre-clinical safety of BrainStorm’s novel adult stem cell technologies in support of its projected clinical studies in ALS.