Genetic ALS: Discussing a difficult diagnosis

FDA clears cell therapy XS-228 for ALS Phase 1 clinical trial

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…

RNS60 safe, well tolerated in EAP for advanced ALS

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 “…

First patient dosed in a Phase 1 study testing AMX0114 in ALS

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…

1st ALS patient enrolled in MN-166 expanded access program

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 living with ALS, I’m OK and not OK

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…