BrainStorm
will not provide ALS therapy under U.S. Right to Try act
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[June 26, 2018] By
Tova Cohen
TEL AVIV (Reuters) - BrainStorm Cell
Therapeutics Inc will not make its experimental stem cell treatment for
neurodegenerative diseases available under the new U.S. "Right to Try" (RTT)
act, citing a failure to find a way to enable all patients to afford the
treatment.
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The U.S.-Israeli company said on Tuesday it will focus on completing
its advanced study for NurOwn in patients with amyotrophic lateral
sclerosis (ALS) as quickly as possible.
U.S. Congress last month approved the RTT bill that would allow
terminally ill patients to try experimental treatments not yet
approved by the Food and Drug Administration. The act, which was
approved by the Senate in August, was signed in to law by President
Donald Trump on May 30.
The bill does not require insurance companies to pay for the
experimental treatments.
BrainStorm said four elements must be satisfied in order to be able
to provide NurOwn to ALS patients under the RTT pathway.

It found solutions for three of them: treating a limited number of
patients at clinical trial-experienced sites for safety reasons,
ensuring patients are educated on the benefits and risks, and
limiting inclusion to patients who do not meet the clinical trial
criteria to avoid impacting the trial.
The fourth: finding alternative funding for patients who are unable
to afford the high cost of cell therapies, was unmet.
"As we are unable to identify a practical funding solution, we,
unfortunately, are not in a position to initiate access to NurOwn
under RTT at this time," BrainStorm CEO Chaim Lebovits said.
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Lebovits has said that the Right to Try act cannot be only for the
rich.
BrainStorm could not estimate what the cost of NurOwn will be after
commercialisation. Personal cell and gene therapies can cost
hundreds of thousands of dollars a year.
Lebovits told Reuters that BrainStorm would provide NurOwn under RTT
to one patient, Matt Bellina, a naval aviator diagnosed with ALS who
helped lead the fight to get the legislation passed. Lebovits said
he would personally sponsor the treatment.
BrainStorm expects to have Phase III trial results at the end of
2019 or early 2020.
According to the ALS Association, 5,600 people in the United States
are diagnosed each year with the illness, also known as Lou Gehrig's
Disease.
(Reporting by Tova Cohen, editing by Stephen Farrell and Louise
Heavens)
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