The U.S. Food and Drug Administration (FDA) has given Xellsmart Biopharmaceutical the go-ahead to start a Phase 1 clinical trial testing its stem cell-based therapy XS-228 in people with amyotrophic lateral sclerosis (ALS). This milestone, reflecting the approval of Xellsmart’s investigational new drug (IND) application, follows promising results…
FDA clears cell therapy XS-228 for ALS Phase 1 clinical trial
Some days, my motivation just gets stuck. Even though I’ve got interesting plans and projects to do, I can’t get started on any of them. The reasons why can include not getting enough hours of sleep the night before, being caught up in the latest news cycle, or simply reflecting…
A combination of three drugs — one of them the experimental therapy CuATSM — may be effective for treating amyotrophic lateral sclerosis (ALS) caused by mutations in the SOD1 gene, according to a new preclinical study. In mice carrying SOD1 mutations, the combination of these three drugs — CuATSM,…
RNS60 was well tolerated when inhaled twice daily at home as part of an expanded access program (EAP), and it could be a safe option for people with advanced amyotrophic lateral sclerosis (ALS), a study suggested. “This EAP supports the safety and tolerability of RNS60,” researchers wrote in “…
The first patient has been dosed in a Phase 1 clinical study testing AMX0114, an experimental therapy being developed by Almylyx Pharmaceuticals for amyotrophic lateral sclerosis (ALS). The treatment targets calpain-2, a protein believed to contribute to nerve cell damage in ALS. Called LUMINA (NCT06665165), the study was cleared…
The first patient has been enrolled in an expanded access program (EAP) trial evaluating MN-166 (ibudilast), Medicinova’s oral anti-inflammatory drug, in people with amyotrophic lateral sclerosis (ALS). EAPs, also known as compassionate use programs, allow patients with serious or life-threatening conditions to access investigational therapies outside of clinical…
In the opening stanza of “For When People Ask,” poet Rosemerry Wahtola Trommer writes: “I want a word that means okay and not okay, more than that: a word that means devastated and stunned with joy. I want the word that says I feel it all all at…
Brainstorm Cell Therapeutics is moving forward in its efforts to get needed regulatory clearances to launch a Phase 3b clinical trial in the U.S. to test its stem cell therapy NurOwn (debamestrocel) in people with amyotrophic lateral sclerosis (ALS) with less advanced disease. The company has submitted to…
The other day, my husband spotted me putting on my sneakers while using a long shoehorn and asked, “Wouldn’t that be a lot easier if we got you a pair of those new step-in shoes?” I’ll admit that living with ALS has me continually thinking of ways to make…
An experimental candidate by Ractigen Therapeutics to treat amyotrophic lateral sclerosis (ALS) linked to mutations in the SOD1 gene has shown promising signs of slowed functional decline and stable or improved breathing in ALS patients of a small early trial. The therapy, RAG-17, also significantly reduced blood levels…
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