Health & Fitness
Health and Fitness
Health and Fitness
Tue, February 10, 2009
Mon, February 9, 2009 BrainStorm Cell Therapeutics? Consultant to Assist with Final Regulatory Preparations Towards Clinical Trials For ALS Patients
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.
About BrainStorm Cell Therapeutics:
BrainStorm Cell Therapeutics Inc. is an emerging company developing adult stem cell therapeutic products, derived from autologous (self) bone marrow cells, for the treatment of neurodegenerative diseases. The NurOwn(TM) patent pending technology is based on discoveries made by the scientific team led by prominent neurologist Professor Eldad Melamed, Head of Neurology at Rabin Medical Center, and expert cell biologist Dr. Daniel Offen, Head of the Neuroscience Laboratory at the Felsenstein Medical Research Center of Tel-Aviv University. The technology allows for the differentiation of bone marrow-derived stem cells into functional neurons and astrocytes, as demonstrated in animal models. The Company holds rights to develop and commercialize the technology through an exclusive, worldwide licensing agreement with Ramot at Tel Aviv University Ltd., the technology transfer company of Tel-Aviv University. The Company's initial focus is on Parkinson's, ALS and Spinal Cord Injury, although its technology has promise for treating several others diseases including MS, Huntington's disease and stroke.
Safe Harbor Statement
Statements in this announcement other than historical data and information constitute "forward-looking statements" and involve risks and uncertainties that could cause BrainStorm Cell Therapeutics Inc.'s actual results to differ materially from those stated or implied by such forward-looking statements, including BrainStorm's ability to complete its equity financing transactions previously disclosed. The potential risks and uncertainties include, among others, risks associated with BrainStorm Cell Therapeutics Inc.'s limited operating history, history of losses and expectation to incur losses for the foreseeable future; minimal working capital and difficulty raising additional capital, dependence on its license to Ramot's technology; ability, together with its licensor, to adequately protect the NurOwn(tm) technology; dependence on key executives and on its scientific consultants; ability to identify, negotiate and successfully implement strategic partnering relationships; ability to complete clinical trials successfully and to obtain required regulatory approvals; competition with companies, some of which have greater resources and experience in developing and obtaining regulatory approval for treatments in BrainStorm Cell Therapeutics Inc.'s market; the limited public trading market for BrainStorm Cell Therapeutics Inc.'s stock which may never develop into an active market; and other factors detailed in BrainStorm Cell Therapeutics Inc.'s annual report on Form 10-KSB, quarterly reports on Form 10-Q, current reports on Form 8-K and other filings with the Securities and Exchange Commission available at[ http://www.sec.gov/ ]or by request to the Company. The Company does not undertake any obligation to update forward-looking statements made by us.
