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FDA okays Phase 3 trial for NurOwn: Brainstorm to also apply for hospital exemption for ALS in Israel.

PETACH TIKVAH, Israel, December 19, 2016 -- BrainStorm Cell Therapeutics Inc. (BCLI) said that after an end-of-Phase 2 meeting with the FDA, the agency allowed the company to proceed to a Phase 3 trial.

The FDA accepted the key elements of the Phase 3 program to support a Biologic License Application (BLA) for NurOwn in ALS.

The planned Phase 3 clinical trial will be a randomized, double-blind, placebo-controlled multi-dose trial that will be conducted at multiple sites in the U.S. and in Israel. The trial is expected to begin enrolling patients in the second quarter of 2017.

In addition, Brainstorm plans to submit an application in Israel that will allow amyotrophic lateral sclerosis (ALS) patients access to NurOwn under hospital exemption.

This recently approved pathway would permit the company to partner with a medical center in Israel and be allowed to treat ALS patients with NurOwn for a fee.

Hospital exemption allows advanced therapy medicinal products to be made available to a group of patients to be agreed upon by the Israeli Ministry of Health.

It is intended to provide patients a custommade, innovative, individual treatment where there is a critical unmet need and an absence of valid therapeutic alternatives.

The treatment is usually manufactured using a patient's own cells that are prepared on a non-routine basis. To qualify for a hospital exemption, the treatment must be prepared according to specific quality standards (equivalent to those for a licensed product), used in a hospital and used under the exclusive responsibility of a medical practitioner.

The decision to proceed with this application is based on a strong interest voiced by ALS patients via a questionnaire.

"We foresee possible treatments under this pathway as early as the second half of 2017," the company said.

Contact: http://www.brainstorm-cell.com

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Title Annotation:In The Clinic...
Publication:Stem Cell Research News
Geographic Code:7ISRA
Date:Jan 16, 2017
Words:297
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