The Israeli Ministry of Health has fast-tracked BrainStorm Cell Therapeutics' current phase I/II ALS (Lou Gehrig's disease) safety trial to a phase IIa dose-escalating trial designed to evaluate the safety and preliminary efficacy of the company's NurOwn stem cell therapy candidate. The acceleration drastically expedites the company's clinical development program and allows for its immediate launch at the Hadassah Medical Center in Jerusalem.
"Acceleration to phase IIa will save us critical time, enabling us to proceed much more quickly with achieving our goal of developing an effective treatment for ALS," Dr. Adrian Harel, BrainStorm's CEO stated in the press release.
The Ministry of Health approved the acceleration after evaluating 12 of the initial cohort of 24 patients in BrainStorm's phase I/II trial at Hadassah. The phase IIa trial involves the second group of 12 patients, which will receive combined intramuscular and intrathecal administration of NurOwn cells in three cohorts, with increasing doses. Previously recruited study participants will be followed for three to six months after transplantation.
"Based on the positive results we have seen for the first 12 patients, we are eager to begin the next stage of clinical testing, and are delighted that the Ministry of Health has given us the green light to proceed to phase IIa," Professor Dimitrios Karussis, principal investigator of BrainStorm's phase I/II trial, stated in the press release.
BrainStorm plans to launch the phase IIa study immediately. The company also anticipates expanding its clinical development to the United States in 2013, pending U.S. FDA approval.
For more information visit brainstorm-cell.com
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