BrainStorm is currently doing a 200-patient, double-blind, placebo-controlled, repeat-dosing NurOwn Phase III study in the US
Catalent and BrainStorm Cell Therapeutics have announced an agreement for the manufacture of NurOwn, BrainStorm’s autologous cellular therapy being investigated for the treatment of amyotrophic lateral sclerosis (ALS), also known as Lou Gehrig's disease or motor neuron disease.
NurOwn induces mesenchymal stem cells (MSCs) to secrete high levels of neurotrophic factors (NTFs) known to promote the survival of neurons and neuroprotection. The therapy has received fast track status from the US FDA for ALS and has also been granted Orphan Drug Status for ALS by both the FDA and the European Medicines Agency.
As part of its commitment, Catalent will undertake the transfer of the manufacturing process to, and provide future CGMP clinical supply of NurOwn from its 32,000 sqft cell therapy manufacturing facility in Houston, Texas. On completion of the clinical trials and in anticipation of potential approval of NurOwn, the companies will look to extend the partnership to include commercial supply from the Houston facility.
“We are proud to have a partner in Catalent whose excellence in manufacturing quality therapies will support commercial supply of NurOwn,” said Chaim Lebovits, CEO of BrainStorm Cell Therapeutics. “We know that ALS patients are in urgent need of a new treatment option. If NurOwn is successful in the current clinical trials, this agreement will be integral to ensuring rapid access for patients.”
Manja Boerman, President, Catalent Cell & Gene Therapy, said: “Our experience in cell therapy development, and the manufacturing capabilities that our newly constructed, state-of-the-art facility in Houston offers, position us to best support BrainStorm, with its leading therapeutic candidate for ALS treatment. We look forward to partnering with BrainStorm and providing our stem cell manufacturing expertise as we work to optimize production and streamline the product’s path towards commercial launch.”