General Topics

Moderators: JohnV, Arron, garym


Postby misterjuanperalta on January 13th, 2015, 6:30 am

Product: NurOwn

BrainStorm Cell Therapeutics Inc. (BCLI) announced positive final results from its phase 2a clinical trial of NurOwn in amyotrophic lateral sclerosis or ALS patients, which enrolled 14 subjects at Hadassah Medical Center in Jerusalem.

The company stated that the study achieved its primary endpoint in demonstrating that NurOwn is safe and well-tolerated at doses up to 2 million cells per kilogram administered intrathecally or IT and 48 million cells administered intramuscularly or IM.

The company stated that nearly all subjects in this study experienced clinical benefit from treatment with NurOwn. Of the 12 subjects with three or more months of follow-up, 92% experienced an improvement in the rate disease progression for the three month period after administration of NurOwn, as measured by ALS Functional Rating Score-Revised or ALSFRS or forced vital capacity (FVC). Fifty percent had an improvement in the slope of the ALSFRS score, and 67% had an improvement in the slope of the percent-predicted FVC.

According to the company, NurOwn slowed the progression of ALS in this study, as indicated by an improving slope of both the mean ALSFRS and mean FVC curves after therapy. On ALSFRS, NurOwn slowed the rate of progression by 45%, from 1.41 points per month during the run-in period to 0.78 points per month for the three months following treatment, and by 57% to 0.60 per month for the six months following treatment.

NurOwn had a similarly strong effect on the progressive loss of lung function - the rate of decline in percent-predicted FVC was reduced by 73%, from an average of 2.60% per month during the run-in period to just 0.70% per month for the three months after treatment, and by 67% to 0.86% per month for the six months following treatment.

Source: ... ary-5-2015

What's more, BrainStorm submitted to the FDA the results of three pilot manufacturing runs performed at the Mayo Clinic, each of which resulted in the production of NurOwn cells that meet the final product release testing acceptance criteria. Upon activation, and subject to Institutional Review Board approval, the Mayo Clinic will become the third and final site enrolling subjects into Brainstorm’s ongoing ALS clinical trial.

Source: ... 00599.html

NurOwn works by boosting production of GDNF, a neuroprotective substance which promotes motoneuron cell survival and growth, utilizing the patient's own bone marrow, which is reprogrammed into GDNF-secreting astrocyte-like cells and reintroduced. NurOwn can likely be administered without anti-rejection medicines.
Posts: 515
Joined: August 21st, 2014, 7:27 am

Re: NurOwn

Postby Xina535 on January 19th, 2015, 3:23 pm

This is awesome!! Thanks for posting this!

I am wondering, "what's next"? Any idea? They mentioned Phase 2a, Phase 3 next? When could it be safe/approved for non-study patients?
Posts: 751
Joined: January 2nd, 2014, 9:46 am

Re: NurOwn



Return to General Topics

Who is online

Users browsing this forum: No registered users and 3 guests