BrainStorm Cell Therapeutics announced yesterday that it has completed the analysis of Phase 2A clinical trial results from its Israel-based research program. None of these results announced are from or include any data collected through their Phase 2 clinical trial in the United States.
According to the
press release, their Phase 2A clinical trial achieved its primary endpoints, which were defined in Israel as safety and tolerability only. The trial was not designed or powered to measure the efficacy of their stem cell treatment, called
NurOwn. The Phase 2A study in Israel was a complex study with 4 PALS in 3 different groups, each receiving different dosing regimens of the stem cells. Until full data is available for review on all of these cases, it is challenging for us to comment further regarding the suggestively hopeful data included in the press release from BrainStorm regarding their treatment’s effects on disease progression measures. We will be reaching out to BrainStorm and asking for more information so that we can better inform people about what this exactly means for the current US-based clinical research program (which is placebo controlled unlike the Israel-based studies) and PALS and ALS research in general. For more information on their approach, we recommend that people view the
webinar at ALS.net conducted with senior staff at Brainstorm. To read the full press release, click here:
http://www.brainstorm-cell.com/index.php/news-events/331-january-5-2015