BrainStorm Announces Publication of Preclinical Multidose...

Wow great news! What a surprise, this is not even the published paper for Phase I.
The bit I like the best is:

"NurOwn is in clinical development for the treatment of amyotrophic lateral sclerosis (ALS or Lou Gehrig's disease) and has demonstrated efficacy in preclinical models of a variety of neurodegenerative diseases, including Parkinson's disease, Huntingon's disease and multiple sclerosis. The results published today are important because they establish that repeated doses of NurOwn are safe in mice and more specifically, that mice generate only minimal immune response after repeated exposure to NurOwn, which are human cells."

So they know NurOwn is efficacious in ALS, Parkinson's, MS, and Huntington's disease. And now we know that multi-dose treatment will work in move even when using human cells.

dayan,

I need to re-listen to that part of the call again. One thing I need to correct from what you quoted me on is that I believe it is the full data set from Phase I and not interim. In the meantime, here is what BCLI says in their latest S-1 filing.


In January 2013, the Israeli MoH approved a Phase IIa combined (intramuscular and intrathecal) treatment, dose-escalating trial, which we are currently conducting at HUMC. According to the protocol for this safety and preliminary efficacy trial, 12 early-stage ALS patients received both intramuscular and intrathecal injections of NurOwn cells in three cohorts with increasing doses between February and August 2013. The patients were followed for six months after transplantation. Due to medical and technical considerations, two additional patients were enrolled in the trial in late 2013, in order to preserve the originally planned protocol design. These two patients were treated at the beginning of the second quarter of 2014. The complete and final statistical analysis of the Phase IIa data is expected to be available after 6 months of follow up with the patients.

So if they were treated in January of this year, 6 months follow up would put us some time in June. That would give at least two months to get it reviewed for publication. So August is still in the timeline for data publication for Phase IIa patients in my opinion. However, Lebovits may have been referring to the final data on the first 12 patients (Phase I) being published in August and the final data on phase IIa only being released via PR.

It's a very good question and like I said I need to go back and double check. At the very least Phase I data could be published at any time, bu maybe they'll wait until they can combine it with Phase IIa.