FDA Clears Mayo Clinic for Manufacture of NurOwn and Participation in BrainStorm's Phase 2 ALS Trial
ACCESSWIRE - Mon Aug 18, 7:13AM CDT
NEW YORK, NY and PETACH TIKVAH, Israel /ACCESSWIRE / August 18, 2014 / BrainStorm Cell Therapeutics (OTCQB: BCLI), a leading developer of adult stem cell technologies for neurodegenerative diseases, announced today that the U.S. Food and Drug Administration (FDA) has cleared the Mayo Clinic Human Cellular Therapy Laboratory in Rochester, Minn. for production of NurOwn™, BrainStorm's proprietary autologous mesenchymal stem cells secreting neurotrophic factors (MSC-NTF). BrainStorm will continue working with the Mayo clinical team to complete the necessary steps to allow the site to begin enrolling subjects into its ongoing phase 2 study of NurOwn™, which is designed to evaluate the safety and efficacy of the transplantation of or NurOwn™ in patients with Amyotrophic Lateral Sclerosis (ALS).
BrainStorm Receives Notice of Allowance on US Patent
ACCESSWIRE - Mon Jul 28, 8:47AM CDT
NEW YORK, NY and PETACH TIKVAH, Israel / ACCESSWIRE / July 28, 2014 / BrainStorm Cell Therapeutics Inc. (OTCQB: BCLI), a leading developer of adult stem cell technologies for neurodegenerative diseases, received Notice of Allowance from the United States Patent Office for Patent Application 12/994,761, titled "Mesenchymal Stem Cells for the Treatment of CNS Diseases."
BrainStorm Announces that University of Massachusetts Memorial Medical Center to Begin Enrolling Patients in Phase 2 ALS Clinical Trial
eTeligis - Tue Jul 15, 10:04AM CDT
Petach Tikvah, Israel, New York, NY, United States, via eTeligis Inc., 07/15/2014 - - BrainStorm Cell Therapeutics (OTCQB: BCLI), a leading developer of adult stem cell technologies for neurodegenerative diseases, announced today that the University of Massachusetts (UMass) Memorial Medical Center in Worcester, MA will begin enrolling patients into the Company's randomized, double-bling placebo-controlled phase 2 clinical trial in Amyotrophic Lateral Sclerosis (ALS). UMass Memorial is the second site to become active of the three sites participating in this trial. The other two clinical sites participating in the multi-center trial are Massachusetts General Hospital (MGH), which began enrolling patients into the trial last month, and the Mayo Clinic, which is expected to become active in the third quarter of 2014. The Dana Farber Cancer Institute's Connell and O'Reilly Cell Manipulation Core Facility will manufacture NurOwn cells for MGH and UMass Memorial.
BrainStorm publishes study of preclinical multidose in mice of NurOwn
M2 - Fri Jul 11, 7:01AM CDT
Adult stem cell company BrainStorm Cell Therapeutics (OTCQB:BCLI) announced on Friday that it has published a preclinical study about the safety of single and repeated intramuscular administration of NurOwn, its proprietary mesenchymal stem cells that are induced to secrete a variety of neurotrophic factors, in the Clinical and Translational Medicine journal.
BrainStorm Announces Publication of Preclinical Multidose Study of NurOwn
Marketwire - Fri Jul 11, 6:08AM CDT
BrainStorm Cell Therapeutics Inc. (OTCQB: BCLI), a leading developer of adult stem cell technologies for neurodegenerative diseases, announced today publication of an important preclinical study in the journal Clinical and Translational Medicine. This paper describes the safety of single and repeated intramuscular administration of NurOwn, the Company's proprietary mesenchymal stem cells that are induced to secrete a variety of neurotrophic factors. NurOwn is in clinical development for the treatment of amyotrophic lateral sclerosis (ALS or Lou Gehrig's disease) and has demonstrated efficacy in preclinical models of a variety of neurodegenerative diseases, including Parkinson's disease, Huntingon's disease and multiple sclerosis. The results published today are important because they establish that repeated doses of NurOwn are safe in mice and more specifically, that mice generate only minimal immune response after repeated exposure to NurOwn, which are human cells. These data will help support the use of multiple doses of NurOwn in future clinical trials.
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PR Newswire Europe - Tue Jul 01, 7:01AM CDT
LONDON, July 1, 2014 /PRNewswire/ --
BrainStorm and Octane Successfully Construct a Bioreactor Prototype for Industrial-Scale Manufacturing or NurOwn Stem Cells
Marketwire - Fri Jun 27, 8:50AM CDT
BrainStorm Cell Therapeutics Inc. (OTCQB: BCLI), a leading developer of adult stem cell technologies for neurodegenerative diseases, and Octane Biotech Inc., a Canadian firm that focuses on clinical systems for cell and tissue therapy, announced today that they have reached an important milestone in their technology collaboration, successfully constructing an Alpha prototype of a customized bioreactor for BrainStorm's NurOwn(TM) neurotrophic-factor secreting mesenchymal stem cells. The proprietary bioreactor under development will provide BrainStorm with large-scale manufacturing capabilities, enabling it to achieve economies of scale for its autologous stem cell product.
BrainStorm Cell Therapeutics Raises $10.5 Million in Private Placement Financing
Marketwire - Fri Jun 13, 8:30AM CDT
BrainStorm Cell Therapeutics Inc. (OTCQB: BCLI), an innovative developer of adult stem cell technologies and Central Nervous System therapeutics, today announced that it has entered into definitive agreements with a group of investors, including several healthcare-focused funds, in connection with a private placement of common stock and warrants to purchase common stock. Upon the closing of this financing, BrainStorm will receive gross proceeds of $10.5 million, resulting from the issuance and sale of 42.0 million shares of common stock at a price per share of $0.25, a 15% discount to the 30 day volume-weighted average price of $0.294. The purchasers will also receive warrants to purchase up to 42.0 million shares of common stock at an exercise price of $0.348 per share. The warrants are exercisable immediately upon closing of the private placement and have a term of three years.
BrainStorm and Massachusetts General Hospital Sign Definitive Agreement for ALS Clinical Trial
Marketwire - Tue Mar 25, 5:01AM CDT
BrainStorm Cell Therapeutics (OTCQB: BCLI), a leading developer of adult stem cell technologies for neurodegenerative diseases, announced today that it has signed a definitive agreement with the Massachusetts General Hospital (MGH) in Boston, MA to conduct a Phase II clinical trial of NurOwn(TM) in amyotrophic lateral sclerosis (ALS), pending FDA and Institutional Review Board approvals. The other two clinical sites slated for the multi-center trial are the University of Massachusetts Memorial (UMass) Hospital and Mayo Clinic. Dana Farber Cancer Institute's Connell and O'Reilly Cell Manipulation Core Facility will manufacture the NurOwn cells for MGH and UMass Hospital.
BrainStorm Granted Key US Patent for Its Autologous Stem Cell Technology
Marketwire - Mon Mar 24, 5:29AM CDT
BrainStorm Cell Therapeutics (OTCQB: BCLI), a leading developer of adult stem cell technologies for neurodegenerative diseases, today announced that the U.S. Patent and Trademark Office has granted the company a key patent for its autologous stem cell technology. The patent (No. 8,663,987) covers BrainStorm's proprietary stem cells induced to secrete elevated levels of neurotrophic factors for the treatment of neurodegenerative diseases.
Amber Road Makes Market Debut; Tranzbyte Corporation Signs LOI with Abattis
ACCESSWIRE - Sun Mar 23, 11:30PM CDT
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BrainStorm to Present Latest Company Developments at Regen Med Investor Day March 26 in New York
Marketwire - Tue Mar 18, 8:45AM CDT
BrainStorm Cell Therapeutics (OTCQB: BCLI), a leading developer of adult stem cell technologies for neurodegenerative diseases, announced today that Mr. Chen Schor, Executive Board Member, will present the company's latest developments at the 2nd Annual Regen Med Investor Day to be held Wednesday, March 26, 2014 in New York City.