Stem Cell Company Preps for ALS Clinical Trial
Tue, 10/01/2013
http://www.cemag.us/news/2013/10/stem-cell-company-preps-als-clinical-trial#.UkudeNKsiSo
BrainStorm Cell Therapeutics, a developer of adult stem cell technologies for neurodegenerative diseases, has launched its activities in the US in preparation for its Phase IIa multi-center clinical trial, with the initiation of the NurOwnT technology transfer process at the Dana Farber Cancer Institute. DFCI's Connell and O'Reilly Cell Manipulation Core Facility will produce NurOwn in its cGMP-compliant cleanroom facilities for the MGH and UMass Hospital clinical sites. The third clinical site in the trial, Mayo Clinic, will produce NurOwn at its own cleanroom facility.
"We are very pleased with the progress we are making at DFCI, this being the final step for submission of the Company's IND application to the US FDA," says Chaim Lebovits, BrainStorm's President.
The Cell Manipulation Core Facility at Dana-Farber Cancer Institute is a manufacturing facility that produces safe and effective novel cellular component therapy that meets all regulatory guidelines for clinical use and also facilitates research to be translated from the bench to the bedside. All procedures are performed in environmentally controlled conditions according to current Good Manufacturing Practices for cell and tissue processing.
In 2012 BrainStorm successfully completed its first-in-man Phase I/II clinical study at Hadassah Medical Center in Jerusalem with 12 ALS patients, demonstrating initial indications of clinical benefit in six patients. BrainStorm's Phase IIa dose-escalating trial at Hadassah is currently underway and the company will release the preliminary efficacy data at the conclusion of the trial.
BrainStorm Cell Therapeutics Inc. is a biotechnology company engaged in the development of first-of-its-kind adult stem cell therapies derived from autologous bone marrow cells for the treatment of neurodegenerative diseases.
Release Date: October 1, 2013
Source: The Associated Press
Tue, 10/01/2013
http://www.cemag.us/news/2013/10/stem-cell-company-preps-als-clinical-trial#.UkudeNKsiSo
BrainStorm Cell Therapeutics, a developer of adult stem cell technologies for neurodegenerative diseases, has launched its activities in the US in preparation for its Phase IIa multi-center clinical trial, with the initiation of the NurOwnT technology transfer process at the Dana Farber Cancer Institute. DFCI's Connell and O'Reilly Cell Manipulation Core Facility will produce NurOwn in its cGMP-compliant cleanroom facilities for the MGH and UMass Hospital clinical sites. The third clinical site in the trial, Mayo Clinic, will produce NurOwn at its own cleanroom facility.
"We are very pleased with the progress we are making at DFCI, this being the final step for submission of the Company's IND application to the US FDA," says Chaim Lebovits, BrainStorm's President.
The Cell Manipulation Core Facility at Dana-Farber Cancer Institute is a manufacturing facility that produces safe and effective novel cellular component therapy that meets all regulatory guidelines for clinical use and also facilitates research to be translated from the bench to the bedside. All procedures are performed in environmentally controlled conditions according to current Good Manufacturing Practices for cell and tissue processing.
In 2012 BrainStorm successfully completed its first-in-man Phase I/II clinical study at Hadassah Medical Center in Jerusalem with 12 ALS patients, demonstrating initial indications of clinical benefit in six patients. BrainStorm's Phase IIa dose-escalating trial at Hadassah is currently underway and the company will release the preliminary efficacy data at the conclusion of the trial.
BrainStorm Cell Therapeutics Inc. is a biotechnology company engaged in the development of first-of-its-kind adult stem cell therapies derived from autologous bone marrow cells for the treatment of neurodegenerative diseases.
Release Date: October 1, 2013
Source: The Associated Press