|
Post by selluwud on Oct 7, 2014 11:04:40 GMT
www.reuters.com/article/2014/10/07/us-brainstorm-cell-als-fda-idUSKCN0HW0JW20141007BrainStorm gets FDA fast-track status for ALS stem cell therapy TEL AVIV Tue Oct 7, 2014 4:26am EDT (Reuters) - Israel's BrainStorm Cell Therapeutics said the U.S. Food and Drug Administration has designated its adult stem cell treatment as a "fast-track" product for the treatment of amyotrophic lateral sclerosis (ALS). BrainStorm's treatment, called NurOwn, is being studied in a mid-stage clinical trial in patients with ALS, also known as Lou Gehrig's Disease. The FDA's fast track program is designed to speed up access to drugs intended to treat serious conditions and which have the potential to address unmet medical needs. "The receipt of fast-track designation from the FDA is an acknowledgement of the unmet medical need in ALS," BrainStorm Chief Executive Tony Fiorino said on Tuesday. "What is so valuable about fast track designation to a small company like BrainStorm is the opportunity to have increased meetings with and more frequent written communication from the FDA," he said, adding that only a small number of cellular therapies have received FDA approval. BrainStorm said the last patient has completed the last visit in its phase 2a clinical trial in ALS at Hadassah Medical Center in Jerusalem. The company expects to release final results of the study in the fourth quarter of 2014. NurOwn is also being studied in a phase 2 clinical trial at three sites in the United States. According to the ALS Association, 5,600 people in the United States are diagnosed each year with the disease, which has severely disabled British physicist Stephen Hawking. (Reporting by Tova Cohen, editing by Louise Heavens)
|
|
|
Post by JHam on Oct 7, 2014 12:47:36 GMT
Great news! I debated adding more yesterday, but instead added more ONCS. Oh well, I am still happy with my medium position. I don't think this will be a huge pps mover as it was kind of expected. They were fast tracked in Israel too. Great news nonetheless. I still believe that after they have some Phase II interim data that some kind of breakthrough designation will also be awarded.
|
|
|
Post by selluwud on Oct 7, 2014 12:55:12 GMT
Great news! I debated adding more yesterday, but instead added more ONCS. Oh well, I am still happy with my medium position. I don't think this will be a huge pps mover as it was kind of expected. They were fast tracked in Israel too. Great news nonetheless. I still believe that after they have some Phase II interim data that some kind of breakthrough designation will also be awarded. Agree, it is very encouraging. I have a small stake here to add to my many other stem cell based biotech companies. The trick is to be on the right horse, not only when the gate is opened, but when you cross the finish line.
|
|
|
Post by dayanand33 on Oct 7, 2014 18:41:36 GMT
Great news! I debated adding more yesterday, but instead added more ONCS. Oh well, I am still happy with my medium position. I don't think this will be a huge pps mover as it was kind of expected. They were fast tracked in Israel too. Great news nonetheless. I still believe that after they have some Phase II interim data that some kind of breakthrough designation will also be awarded. "BrainStorm said the last patient has completed the last visit in its phase 2a clinical trial in ALS at Hadassah Medical Center in Jerusalem. The company expects to release final results of the study in the fourth quarter of 2014."It seems that the company is set to reveal the complete data set of 2a by end of this quarter. Are you anticipating a Phase II a interim data before that?
|
|
|
Post by JHam on Oct 7, 2014 21:16:55 GMT
Great news! I debated adding more yesterday, but instead added more ONCS. Oh well, I am still happy with my medium position. I don't think this will be a huge pps mover as it was kind of expected. They were fast tracked in Israel too. Great news nonetheless. I still believe that after they have some Phase II interim data that some kind of breakthrough designation will also be awarded. "BrainStorm said the last patient has completed the last visit in its phase 2a clinical trial in ALS at Hadassah Medical Center in Jerusalem. The company expects to release final results of the study in the fourth quarter of 2014."It seems that the company is set to reveal the complete data set of 2a by end of this quarter. Are you anticipating a Phase II a interim data before that? No. I think they will release Phase I/IIa data from the Israeli trial this quarter. I am referring to Phase II interim data from the USA trial in relation to a potential breakthrough status being awarded. I think at the very least the FDA will want to see some data from this new trial before considering awarding it.
|
|