Scottsdale 7/31/2013 3:00:00 AM
BrainStorm Cell Therapeutics (BCLI) Gets European Orphan Drug Designation for NurOwn Treatment
QualityStocks would like to highlight BrainStorm Cell Therapeutics (OTC.QB: BCLI), a biotechnology company developing innovative, autologous stem cell therapies for highly debilitating neurodegenerative diseases such as Amyotrophic Lateral Sclerosis (ALS, also known as Lou Gehrig's disease), Multiple Sclerosis (MS), and Parkinson’s Disease (PD). The company's proprietary, first-of-its-kind technology for the propagation and differentiation of autologous Mesenchymal Stem Cells (MSCs) into NeuroTrophic Factor (NTF)-secreting cells and their transplantation at or near the site of damage, offers the hope of conquering neurodegenerative diseases.
In the company’s news,
BrainStorm Cell Therapeutics reported that the European Commission has granted ‘orphan drug’ status for NurOwn. This is BrainStorm’s adult stem cell therapy, consisting of bone marrow-derived mesenchymal stromal cells secreting neurotrophic factors, for treatment of Amyotrophic Lateral Sclerosis (ALS), which is also known as Lou Gehrig’s Disease. The company received a similar designation from the U.S. FDA in 2011.
This is a key development for BrainStorm. Orphan drugs in the European Union receive the benefit from 10 years of market exclusivity after getting marketing approval. Additional benefits include reduced fees for activities such as applications for marketing authorization, inspections and protocol assistance, as well as possible eligibility for European Union grants and other research and development-supporting activities.
Progress is being made on further advancement of NurOwn. The company is currently conducting a Phase IIa dose-escalating trial with a dozen ALS patients at the Hadassah Medical Center, located in Jerusalem, Israel. BrainStorm anticipates launching a Phase II multi-center trial at three leading medical institutions in the United States towards the end of this year, pending FDA approval.
About QualityStocks
QualityStocks, based in Scottsdale, Arizona, is a free service that collects data from hundreds of Small-Cap and Micro-Cap online Investment Newsletters into one Daily Newsletter Report. QualityStocks is dedicated to assisting emerging public companies with their investor communication efforts and connecting subscribers with companies that have huge potential to succeed in the short and long-term future.
To sign up for The QualityStocks Daily Newsletter, please visit www.QualityStocks.com
To connect with QualityStocks via Facebook, please visit http://Facebook.com/QualityStocksPage
To connect with QualityStocks via Twitter, please visit http://Twitter.com/QualityStocks
Please read FULL disclaimer on the QualityStocks website: http://Disclaimer.QualityStocks.com
Forward-Looking Statement:
This release may contain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. All forward-looking statements are inherently uncertain as they are based on current expectations and assumptions concerning future events or future performance of the company. Readers are cautioned not to place undue reliance on these forward-looking statements, which are only predictions and speak only as of the date hereof. Risks and uncertainties applicable to the company and its business could cause the company's actual results to differ materially from those indicated in any forward-looking statements.
