BrainStorm Cell Therapeutics has requested a Type A meeting with the U.S. Food and Drug Administration (FDA) to discuss the agency’s recent refusal to review its application for NurOwn as a treatment for amyotrophic lateral sclerosis (ALS). Type A meetings are scheduled to resolve differences between the…
Health Canada asked more information regarding masitinib as a potential add-on therapy for amyotrophic lateral sclerosis (ALS) before continuing to review a request for its approval. AB Science, masitinib’s developer, now has 90 consecutive days to reply to the notice of deficiency issued by Health Canada, given…
For my late husband, Jeff, and me, the most difficult and saddening aspect of his ALS progression was the loss of his voice. It was heartbreaking for both of us when he lost the ability to speak, also known as dysarthria, early in his condition. Much of Jeff’s…
A low dose of aldesleukin, an immunotherapy approved for certain cancers, slowed disease progression and significantly improved survival in people with amyotrophic lateral sclerosis (ALS), particularly in those with less aggressive disease. These are the most recent results from the MIROCALS Phase 2 trial (NCT03039673), which tested aldesleukin…
Because life with ALS only gets harder as time goes by, prayer has felt increasingly unproductive for me. And after more than a decade of watching my husband, Todd, suffer from the disease, my prayers have been full of dismay. “God, are you there? Don’t you care? Don’t you…
DNL343, an investigational oral small molecule developed by Denali Therapeutics, can extensively enter the brain and reduce the cellular stress response that contributes to amyotrophic lateral sclerosis (ALS) progression. That’s according to an interim analysis of data from a Phase 1b clinical trial (NCT05006352), in which DNL343 was…
Neuvivo’s NP001 (sodium chlorite) may help slow the progression of amyotrophic lateral sclerosis (ALS) by taming the systemic inflammation caused by gut bacteria leaking into the bloodstream, according to a new analysis of Phase 2 trial data. The findings point to microbial translocation, which occurs when bacteria break through…
I remember the first time someone asked me, “What is ALS?” It was an awkward moment and the question caught me completely off guard. Why? Because only a few months earlier I had received an ALS diagnosis and was searching for the answer to that very question myself. “Um…
For the last 15 years, students in the physical therapy assistant (PTA) program at Northeast Community College in Norfolk, Nebraska have participated in a local amyotrophic lateral sclerosis (ALS) event that seeks to raise awareness about the progressive neurodegenerative disorder — and raise the funds to fight it. This…
Eikonoklastes Therapeutics and Forge Biologics have announced a new partnership to advance the development of ET-101, an experimental gene therapy for amyotrophic lateral sclerosis (ALS), toward clinical trial testing. Eikonoklastes acquired the rights to ET-101 from the University of California San Diego earlier this year. Under…
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