Phase II Trial Set to Begin at Top US Clinical Sites: Massachusetts General Hospital, UMass Medical Center, and the Mayo Clinic; Available for Download at www.lifesciadvisors.com/clients/brainstorm/
NEW YORK, NY--(Apr 30, 2013) - 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 theirNurOwn™ 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, orNurOwn. 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.
Dr. McDonald's full Initiation Report is available to download at no cost at the LifeSci Advisors website, www.lifesciadvisors.com. In addition to this Initiation Report, LifeSci Advisors will also provide ongoing coverage and event-based research updates on the Company as developments occur.
The LifeSci Advisors research team is led by Dr. Andrew I. McDonald, an industry veteran with more than 15 years of healthcare industry experience. Prior to co-founding LSA, Dr. McDonald was the Senior Biotechnology Analyst at Great Point Partners, a leading health care investment firm with over $500 million under management. Before Great Point, he was Co-Head of Healthcare Research and Lead Biotechnology Analyst at ThinkEquity Partners, a boutique investment banking firm focused on growth companies. Dr. McDonald holds a Ph.D. in organic chemistry from the University of California, Irvine, and, earlier in his career, worked as a medicinal chemist at both Pfizer and Cytokinetics.
About LifeSci Advisors:
LifeSci Advisors (LSA) is a leading research firm and communications consultancy dedicated to the life sciences industry. The firm provides strategic counsel, customized marketing communications, comprehensive research reports and investor relations services to companies that specialize in the discovery, development and commercialization of drugs, drug delivery systems, medical devices and diagnostics. To learn more about LSA, visit the company's website, www.lifesciadvisors.com.
The research report described in this press release is not intended as an offering, recommendation, or a solicitation of an offer to buy or sell securities. The securities discussed in LSA research reports may be unsuitable for some investors depending on their specific investment objectives, financial status, risk profile, or particular needs. Investors should consider LSA reports as only a single factor in making their investment decisions and should not rely solely on these reports in evaluating whether or not to buy or sell the securities of the subject company. LifeSci Advisors has been compensated by the company that is the subject of the report described and future research reports, investor relations services, and general consulting services. Please read each report's full disclosures and analyst background on the LSA website, www.lifesciadvisors.com, before investing. LifeSci Advisors is not a registered investment adviser or broker-dealer.
This press release contains forward-looking statements subject to risks and uncertainties that could cause actual results to differ materially from those projected. These forward-looking statements represent LSA's judgment as of the date of this release. LifeSci Advisors disclaims, however, any intent or obligation to update these forward-looking statements.
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SOURCE: LifeSci Advisors