BrainStorm Cell Therapeutics’ Consultant to Assist with Final Regulatory Preparations Towards Clinical Trials For ALS Patients Based on Stem Cells Treatment

NEW YORK & PETACH TIKVAH, Israel - (Business Wire) BrainStorm Cell Therapeutics Inc. (OTCBB:BCLI), a leading developer of adult stem cell (ASC) technology, announced today that the company has retained the services of Bio Medical Research Design (BRD) headed by Dr. Moshe Neuman to consult BrainStorm’s regulatory team in its preparations for clinical trials of ALS patients in Israel.

BrainStorm previously announced its plan to proceed to clinical trials for ALS disease in Israel and therefore engaged BRD to assist with the various final pre-clinical studies and stem cells production process that will help fulfill the relevant regulatory requirements.

BRD has a strong track record assisting its clients obtain regulatory approval for many medical treatments and medical devices via the Israeli Health Ministry.

BrainStorm will now proceed with the plan outlined by BRD and expects to be ready to approach and start the clinical trials once granted the approval by the Israeli Health Ministry by the fourth quarter of 2009 or the first quarter of 2010. Prior to commencing these trials, BrainStorm will need to obtain the necessary financing.

"Based on our vast experience with clinical trials, positive study approvals by the Ministry of Health in Israel and after a thorough analysis of BrainStorm’s scientific background and know-how, we are confident that our decision to consult the company will assist the development process and ensure that it is well-focused and efficient,” said Dr. Neuman.

The first clinical trials will focus on showing safety. Being that BrainStorm’s cell treatment is based on Adult Stem Cells and an autologous transplantation, our scientists believe that the treatment is safe and do not expect any adverse effects. Once successful, we will be able to proceed to Phase II for efficacy.

“We are very pleased to have Dr. Neuman and BRD on board with us. He will, with G-D’s help, provide substantial consultation to BrainStorm’s road towards clinical trials,” commented Chaim Lebovits, President of BrainStorm.

http://www.earthtimes.org/articles/s...o,709170.shtml