NMSS Awards $495K to Study Biomarkers in Phase 2 Trial of NurOwn in Progressive MS
BrainStorm Cell Therapeutics received a $495,330 grant from the National Multiple Sclerosis (MS) Society to support biomarker studies in its ongoing clinical trial testing the cell therapy NurOwn in patients with progressive multiple sclerosis (MS).
NurOwn is a treatment based on the patients’ own bone marrow-derived mesenchymal stem cells (MSC) that have been engineered to secrete growth factors. These factors are believed to protect nerves from damage, promote the repair of myelin (the protective coat of neurons that is destroyed in MS), and ultimately slow or stabilize disease progression.
BrainStorm received the grant through the society’s Fast Forward program, which was created to help support commercial organizations working to develop new therapies and diagnostic tools for MS.
“This research funding will help advance our investigational therapy NurOwn as a potential unmet need for patients with progressive MS. MS continues to devastate the lives of patients and their families, and we thank the National MS Society for helping us advance our innovative research program,” Chaim Lebovits, president and CEO of BrainStorm, said in a press release.
The Phase 2 clinical study (NCT03799718) is currently enrolling up to 20 adults with either secondary progressive or primary progressive MS at three U.S. sites: the Keck School of Medicine of USC, the Stanford School of Medicine, and the Cleveland Clinic. Contact information is available here.
This trial is multi-dose and open-label, meaning all enrolled will be treated. Participants will undergo a bone-marrow aspiration to obtain their stem cells, then be given three NurOwn transplants into the spinal fluid (intrathecal transplant) over 16 weeks. Each will be followed for at least another 12 weeks to assess the treatment’s safety and efficacy.
“Currently, progressive MS treatment options are limited, and NurOwn is a promising new autologous cellular treatment modality that has the potential to directly address MS disease pathways,” said Ralph Kern, MD, the COO and CMO of BrainStorm.
“This funding from the National MS Society will help us explore key neuroinflammation and neural repair biomarkers in progressive MS to confirm NurOwn’s unique mechanism of action, and guide the design of future clinical trials to address this important unmet patient need,” Kern added.
One of the MS Society’s goals is to “accelerate research to improve clinical care for people living with MS,” said Mark Allegretta, PhD, its vice president for research.
“We’re pleased to work with BrainStorm to test a broad panel of biomarkers of neuroinflammation and repair as correlates of the effect of treatment with NurOwn,” Allegretta added.