BrainStorm Cell Therapeutics Inc. has announced that it has secured its second U.S. manufacturing location for NurOwn®, an experimental drug currently under investigation for the treatment of amyotrophic lateral sclerosis in a Phase 3 clinical trial. The original article can be read here, at BrainStorm’s website.
The Manufacturing Agreement
The second manufacturing site for NurOwn is available as a result of working with Connell and O’Reilly Families Cell Manipulation Core Facility at Dana-Farber Cancer Institute (Dana-Farber). Dana Farber is experienced in stem cell transplantation and was involved in manufacturing NurOwn for a Phase 2 trial.
Dr Ritz, an Executive Director of Connell and O’Reilly Families Cell Manipulation Core Facility, says,
“Our participation will allow more rapid patient accrual and will lead to earlier completion of the study.”
This second manufacturing facility will support the on-going Phase 3 trial of NurOwn for the treatment of amyotrophic lateral sclerosis.
About Amyotrophic Lateral Sclerosis (ALS)
ALS refers to a group of progressive conditions that typically affect neurones (nerve cells) involved in controlling voluntary muscle movement. It causes neurones to become damaged and die so that they are unable to transmit messages between the brain and the muscles. ALS is itself part of a broader group of conditions called motor neurone diseases.
People with ALS often experience symptoms such as muscle twitching, weakening, wasting, stiffness, and a loss of voluntary control. People who have ALS may also find it difficult to chew or swallow, and may have slurred speech.
Approximately 14,000 to 15,000 Americans develop ALS. In the majority (around 90%) of cases, ALS is sporadic, which means that it develops without a clear reason why. In the other ~10% of cases it is familial (inherited).
About the Trial of NurOwn
NurOwn is currently being investigated as a possible treatment for ALS in a Phase 3, randomised, double-blind clinical trial.
BrainStorm has stated that enrollment for the trial is going well in all of the six sites in the US that are involved with the trial. It is expected that approximately 200 patients will take part in the study.
