TEL AVIV, Dec 19 (Reuters) - Israel’s BrainStorm Cell Therapeutics said it is proceeding to a Phase 3 clinical trial for its adult stem cell treatment in patients with amyotrophic lateral sclerosis (ALS).
This follows a “successful end-of-Phase 2 meeting” with the U.S. Food and Drug Administration regarding the treatment it is developing, called NurOwn, the company said on Monday.
The advanced clinical trial, to be conducted at multiple sites in the United States and in Israel, is expected to begin enrolling patients in the second quarter of 2017.
“Building off NurOwn’s safety and clinical efficacy observed to date, we are developing a Phase 3 programme that, if successful, will position us to bring to the market an innovative, disease modifying treatment for patients suffering from ALS,” said BrainStorm Chief Executive Chaim Lebovits.
BrainStorm plans to submit an application in Israel that will allow patient access to NurOwn as a treatment that has been granted Hospital Exemption. This recently approved pathway would permit BrainStorm to partner with a medical centre in Israel and be allowed to treat patients with NurOwn for a fee.
This pathway usually involves a custom-made product, such as NurOwn, which is made using a patient’s own cells.
“We foresee possible treatments under this pathway as early as the second half of 2017,” Lebovits said.
According to the ALS Association, 5,600 people in the United States are diagnosed each year with the neurodegenerative disease, also known as Lou Gehrig’s Disease, which has severely disabled British physicist Stephen Hawking. (Reporting by Tova Cohen)