PRESS RELEASE: Groundbreaking Meeting with FDAAugust 7, 2019
FOR IMMEDIATE RELEASE: August 7, 2019
CONTACT: Jazmin Beltran ([email protected])
I AM ALS becomes the first ALS patient advocacy group to bring together senior FDA leadership and a biotechnology company for an in-person meeting
WASHINGTON, D.C. – In a first-of-its-kind meeting, I AM ALS brought together senior leadership from the Food and Drug Administration (FDA) and Brainstorm Cell Therapeutics, a U.S. biotechnology company that is developing a potential breakthrough ALS treatment, NurOwn. NurOwn has been studied in 4 clinical trials to date, and is currently the only ALS treatment nearing the end of its phase 3 clinical trial.
The groundbreaking meeting was the first in-person meeting ever convened by an ALS patient advocacy group between senior FDA leadership and a biotechnology company. I AM ALS arranged the meeting to discuss Brainstorm’s ongoing phase 3 clinical trial of NurOwn as well as efforts to speed treatment access to the ALS patient community.
The meeting enabled an open dialogue between the FDA and Brainstorm that sets the stage for future meetings to explore bringing this treatment to those living with ALS as expeditiously as possible.
I AM ALS presented the FDA with two petitions signed by more than 20,000 individuals calling on the FDA to release its updated Clinical Trial Guidance for ALS Treatments and to approve pending ALS treatments as expeditiously as possible.
“We see everyday the stories of ALS patients who have received NurOwn or participated in Brainstorm’s clinical trials. These stories, in which patients describe the slowing or reversal of their disease, if confirmed, are a potentially game changing development in the fight against ALS for which there is currently no cure and which on average kills those suffering from it within 2 to 5 years,” said I AM ALS Co-Founder Brian Wallach.
Wallach added: “At I AM ALS, we are committed to helping any company searching for ALS cures do so as quickly as possible to help those suffering today. We commend Brainstorm for taking this meeting and for its commitment to finding a much needed treatment option. We appreciate that FDA leadership made this meeting a priority, and thank them for their willingness to explore every way possible to accelerate potentially life saving treatments. We will continue to push for approval of these treatments and look forward to working with FDA leadership to expedite making breakthrough treatments available to every ALS patient as soon as possible.”
About I AM ALS
Founded in 2019 by Brian Wallach and his wife, Sandra Abrevaya, I AM ALS was born out of their desire to change the future for Brian and the thousands of other ALS patients in the world. I AM ALS brings together patients, advocates, organizations and scientists to deliver critical and innovative resources for patients, empower and mobilize patients and their networks to lead the fight for a cure, and transform the public understanding of ALS with a goal of flooding the research pipeline with new, lifesaving drugs. A cure is possible ... if we work together to re-imagine the fight against ALS. Learn more here: https://iamals.org
ALS is a disease that attacks cells in the body that control movement. It makes the brain stop talking to the muscles, causing increased paralysis over time. Ultimately, ALS patients become prisoners within their own bodies, unable to eat, breathe, or move on their own. Their mind, however, often remains sharp so they are aware of what’s happening to them. Today, ALS is always fatal and patients typically live for 2 to 5 years after diagnosis. That’s because scientists have yet to identify a cure for ALS. The recent acceleration of research has ensured that this will change. It is now not a question of if, but when there will be a significant treatment breakthrough that brings a cure within reach.