BrainStorm Cell Therapeutics
After an initial spate of publicity on July 3, 2012, perhaps instigated by a patient who had been provided compassionate usage of the BrainStorm trial procedure in Israel, ALSWW advised BrainStorm's management of the impropriety and misleading nature of that publicity. In fairness, the publicity was neither initiated or fully endorsed by BrainStorm and Hadassah Hospital, but we felt there was a certain benign neglect in not speaking out against the excessively enthusiastic and, we feel, inappropriate suggestions of a "cure", "miracle" or anything beyond a "hopefully positive result".
With that background, we are pleased to read and pass on the following current press release from BrainStorm, which appears to be a far more appropriate, accurate (and believable) statement of result to date.
Click to read full press release
Enhanced Mysenchymal Stem Cell Implantation
BrainStorm is a publicly traded, US/Israeli based biotechnology company, established in 2004, to focus on the development of innovative adult stem cell therapies for highly debilitating neurodegenerative diseases such as Amyotrophic Lateral Sclerosis and Parkinson’s Disease. BrainStorm is the first company in Israel to receive approval from the Israeli Ministry of Health to proceed with a differentiated stem-cell based therapeutic clinical trial. Approval from the Hadassah University Medical Center ethics committee was obtained in May 2011. Guided by a passionate desire to see the results of their efforts within their lifetime, BrainStorm’s scientific team and business managers have chosen to focus their first commercialization efforts on combating ALS with neurotrophic factor secreting cells.
The BrainStorm core technology, NurOwn, is based upon the scientific achievements of both Professor Daniel Offen and Professor Eldad Melamed. Their combined research efforts in molecular and cellular neurobiology, neuropharmacology and animal models of neurodegenerative diseases, form the basis of the BrainStorm clinical trials.
The NurOwn technology processes adult human mesenchymal stem cells that are present in bone marrow and are capable of self-renewal as well as differentiation into many other cell types. The research team is among the first to have successfully achieved in-vitro differentiation of adult bone marrow cells, both animal and human, into astrocyte-like cells capable of releasing neurotrophic factors, including glial-derived
neurotrophic factors (GDNF). The ability to induce differentiation into astrocyte-like cells along with intramuscular and intrathecal delivery makes NurOwn technology highly attractive for treating ALS and Parkinson’s Disease as well as MS and spinal cord injury.
The ALS Phase I/II clinical trial testing safety, tolerability and efficacy began August 2011 with pre-clinical patient observation and selection at Hadassah University Medical Center for a total of 24 patients throughout several months. Principal Investigator Dr. Dimitrios Karussis with assistance from Dr. Marc Gotkine isdirecting the Phase I/II clinical trial underway at Hadassah Medical Center.
Dr. Adrian Harel, CEO and COO of BrainStorm, received his PhD in Neurobiology from Weizmann Institute of Science and his post doctorate from Washington University. He has long been involved with major pharmaceutical and biotechnology companies as CEO of both Meditor Pharmaceuticals Ltd. and Aminolab Technologies 2000 Ltd.
In July 2011, collaborations between BrainStorm with both Massachusetts General Hospital and the University of Massachusetts Medical School were announced. Once BrainStorm develops the protocol for the ALS clinical trials, selects US production facilities and receives FDA approvals, the US trial will be conducted in parallel with
trials underway in Israel. The University of Massachusetts team will be led by Professor Robert Brown, MD, and chair of the neurological department, a renowned expert in ALS. The Massachusetts General Hospital team will be led by Professor Merit Cudkowicz, MD, expert in clinical trial design and therapy development for neurodegenerative disorders, experienced in leading many clinical trials in the
development of new treatments for ALS sufferers.