TEL AVIV (Reuters) - BrainStorm Cell Therapeutics Inc BCLI.O 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.
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.
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
Our Standards: The Thomson Reuters Trust Principles.