Today, Brainstorm Cell Therapeutics, an innovative developer of adult stem cell technologies targeting ALS, issued a press release and led a press conference outlining the company’s clinical development objectives for 2017. The conference was conducted by Chaim Lebovits, the President and CEO of Brainstorm, which is based in Petach Tikvah, Israel and Hackensack, N.J.
Their first goal includes starting a Phase III clinical trial of NurOwn® stem cells as early as the second half of 2017 in both the U.S. and Israel, which was agreed upon by the U.S. Food and Drug Administration (FDA). Full details of the trial were not provided; however, it was stated that they plan on enrolling approximately 150 patients with a 1:1 randomization of NurOwn® stem cells to placebo. The run-in period to derive NurOwn® stem cells from each participant should be the same as in the Phase II trial - a one-time derivation over a three month period, where the stem cells will be cryopreserved. The trial protocol is still being finalized, but it is anticipated that study participants would receive a treatment of either stem cells or placebo every two months for a total of three treatments. The overall cost of the trial, funding sources, trial sites and any pharmaceutical company partnerships were not disclosed.
The second discussed goal is for the company to submit an application for Hospital Exemption for NurOwn® in Israel. This means that if the application is approved, Brainstorm could partner with medical centers in Israel to make NurOwn® available to a group of patients for a fee. The possible Israeli medical centers involved and the treatment cost was not disclosed. Brainstorm has not applied for Accelerated Approval to the FDA in the U.S.
For more information about recent results from Brainstorm’s phase II in the U.S. and about NurOwn® stem cells please click here.
To read Brainstorm’s press release, click here.
For questions regarding this news, please contact Brainstorm Therapeutics.