NEW YORK, NY -- (Marketwired) -- 04/30/13 -- LifeSci Advisors, LLC, a leading provider of investment research and investor relations services in the life sciences sector, today announced that it has initiated coverage of BrainStorm Cell Therapeutics Inc. (OTCQB: BCLI), a biotechnology company with a unique approach to treating debilitating neurodegenerative diseases. Positive Phase I/II safety and efficacy results were presented in March 2013 for the Company's stem cell technology as a treatment for amyotrophic lateral sclerosis (ALS). BrainStorm's presentation was specifically chosen for expedited release in the Emerging Science Session at the American Academy of Neurology conference. A new Phase IIa study was initiated in Israel in December 2012 and a second Phase II trial is slated to begin after IND approval in late 2013 at three top US clinical sites, Massachusetts General Hospital, UMass Medical Center, and the Mayo Clinic.
"ALS is a complex and difficult disease to treat, and there is a great need for new therapies to address the underlying disease pathology," said Andrew I. McDonald, Ph.D., Founding Partner at LifeSci Advisors. "BrainStorm has presented promising early safety and efficacy data for their NurOwn stem cell therapy, which delivers neurotrophic factors directly to the patient's compromised nervous system, and this may prove to be a revolutionary treatment for ALS."
The Phase I/II trial met the primary endpoints of safety and efficacy. No serious treatment related adverse events were reported from the 12 patients enrolled, and 50% of the patients reported no adverse events at all. The study was an interventional, non-randomized trial to monitor safety and tolerability of the NurOwn technology in patients with ALS. Efficacy was measured by changes in the rate of Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised (ALSFRS-R) decline and rate of forced vital capacity (FVC) decline when comparing the 3 months pre-treatment with the 6 months post-treatment. Significant decreases were reported in the rate of ALSFRS-R decline (p=0.0013) and FVC decline (p < 0.0001) in the intrathecal (IT) transplanted patients. These results indicate a trend toward possible stabilization of the disease.
NurOwn is a novel stem cell technology that BrainStorm has developed using bone marrow-derived mesenchymal stem cells (MSC) harvested from the patient receiving the treatment. These autologous cells are differentiated into neuron-supportive cells that secrete neurotrophic factors (NTF) such as glial-derived neurotrophic factor and brain-derived neurotrophic factor, thus they are referred to as "MSC-NTF" cells, or NurOwn. Autologous adult stem cell therapy is free of the immune-related issues associated with allogeneic approaches that use cells from donors, as well as the ethical issues that are raised with the use of embryonic stem cells.
In a 25 page Initiation Report by LifeSci Advisors, we explain BrainStorm's technology and development plans for the NurOwn technology. The report provides a deep look into the scientific rationale underpinning the ALS development program, competing products and development programs, and examines the patient population and market opportunity for ALS.
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