PARADIGM Trial for PrimeC Set to Enroll Soon in US, Italy

PARADIGM Trial for PrimeC Set to Enroll Soon in US, Italy

NeuroSense Therapeutics has received the go-ahead to begin enrolling patients in the U.S. and Italy for a Phase 2b clinical trial testing PrimeC, the company’s experimental therapy for amyotrophic lateral sclerosis (ALS). The clinical trial, called PARADIGM (NCT05357950), enrolled its first participant in June. The study is…

FDA Gives ET-101, Gene Therapy for ALS, Orphan Drug Status

ET-101, Eikonoklastes Therapeutics’ experimental gene therapy for amyotrophic lateral sclerosis (ALS), has been designated an orphan drug by the U.S. Food and Drug Administration (FDA). Orphan drug status is given to investigational therapies with the potential to significantly benefit people with life-threatening or chronically debilitating diseases that affect…

ALS Success Story Delivers Man’s ‘Most Special Day’

The Lifestyle Healing Institute (LHI), which uses a complementary and alternative medicine approach to care, is touting the success of an amyotrophic lateral sclerosis (ALS) patient whose mobility and quality of life are said to have improved following treatment. The case of Tod, a 60-year-old patient, demonstrates that…

FDA Declines to Consider Approving NurOwn to Treat ALS

The U.S. Food and Drug Administration (FDA) notified Brainstorm Cell Therapeutics that it will not accept for review a company application asking that its cell-based therapy NurOwn be approved as a treatment for amyotrophic lateral sclerosis (ALS). The FDA decision, in the form of a refusal to file…

Radicava Oral Suspension Approved in Canada to Treat ALS

Radicava Oral Suspension, an oral formulation of edaravone, has been approved in Canada for treating amyotrophic lateral sclerosis (ALS). Mitsubishi Tanabe Pharma Canada (MTP-CA), the subsidiary of Mitsubishi Tanabe Pharma America that markets Radicava in Canada, has announced plans to make the oral formula available to patients…