BrainStorm to start Phase 2 ALS trial

The FDA approves the commencement of a Phase 2 double-blinded clinical trial for Brainstorm Cell Therapeutics' (BCLI +2.1%) NurOwn mesenchymal stem cells for the treatment of ALS patients.

The trial will begin at Mass General Hospital in Boston and the UMass Memorial Hospital in Worchester after the respective IRB approvals. The Mayo Clinic will also participate.

Dana-Farber Cancer Institute's Connell O-Reilly Cell Manipulation Core Facility will manufacture the NurOwn cells for the two MA sites.

The trial will evaluate the safety and efficacy of the transplantation of Autologous Mesenchymal Stem Cells Secreting Neurotrophic Factors (NurOwn) in 48 ALS patients. The cells will be administered in combined intramuscular and intrathecal injections.

The primary endpoint is safety and tolerability as defined by the number of patients with adverse events. Secondary endpoints will measure the changes in ALS Functional Rating Scale and Slow Vital Capacity.

Last week, Cytokinetics (CYTK -5.3%) announced the failure of its ALS drug in a Phase 2b trial.

Neuralstem's (CUR +0.5%) Phase 2 trial for NSI-566 in ALS patients began in Q4 2013.

Comments (3)
  • toosmarttofail
    , contributor
    Comments (699) | Send Message
    Non-embryonic cell companies, Phase II, and a big runup haven't been a good mix lately. Just ask investors in ATHX.


    ACTC has embryonic cell technology. Non-embryonic cells were a political and economic alternative for politicians and researchers who needed to avoid controversy and get funding. The science has never been proven the way embryonic has, and Dr. Lanza recently published a paper that says embryonoic cells are 30,000x more efffective.


    I don't like shorting this sector, but if I did, CUR would be my first and only short right now. I would say if you are long, to perhaps consider options as a way to cover your bet with far less risk. Just ask those who got slaughtered today by ATHX if that wouldn't have been better for them.
    28 Apr 2014, 11:56 AM Reply Like
  • Tile
    , contributor
    Comments (119) | Send Message
    $ATHX was already on a steady decline before today's beating. From a high of more than $4 to $2 and change was a sign to get out. Why would you short $CUR? Answer my question after a complete DD on the stock. Dr Lanza at ACTC is a true superstar, but the stock is stuck at 6 cents for quite some time is a real reason for concern.
    28 Apr 2014, 11:46 PM Reply Like
  • MoneyGrubber13
    , contributor
    Comments (305) | Send Message
    Don't hold your breath. TTF doesn't reply to questions or comments directed to him. He uses a one directional mega-phone to cast his opinions.
    12 May 2014, 12:45 PM Reply Like
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