BrainStorm Cell Therapeutics Inc. has announced that after careful consideration of the newly enacted right-to-try (RTT) legislation, it will not make stem-cell therapy (Nurown) available to patients outside of clinical trials at this time. Instead, the company plans to focus efforts on completing the ongoing phase 3 study of stem-cell treatment for patients with amyotrophic lateral sclerosis (ALS) as quickly as possible.
Brainstorm states they carefully evaluated the ethical, legal, and practical aspects of the newly enacted RTT legislation in detail. The company also solicited and received detailed feedback from patients, clinicians, regulatory, and legal experts. From this data and analysis, BrainStorm established a framework of 4 key pillars to satisfy in order to provide the treatment to patients with ALS patients under the RTT pathway. First, providing treatment to a limited number of patients at sites experienced in the ongoing clinical trials to ensure the expertise and systems of care for safe and effective delivery of therapy are present. Second, ensuring sufficient patient education on the benefits and risks of the investigational therapy. Third, providing treatment via the RTT pathway only to patients who do not meet the phase 3 clinical trial inclusion criteria to prevent compromising the trial. Fourth, finding alternative funding for patients who can not afford the treatment. The company has found practical solutions for the first 3 of these 4 pillars, but has not been able to secure the fourth, funding for all. As a result, the company states it is unable to begin providing treatment via the RTT pathway at this time.
"We feel a tremendous sense of urgency and responsibility to provide an ethical, compassionate, and well-reasoned practical response to the demand for Nurown and have worked tirelessly with patients and other stakeholders to find a solution," said Chaim Lebovits, president and CEO of BrainStorm, "As we were unable to identify a practical funding solution, we unfortunately are not in a position to initiate access to Nurown under RTT at this time."Next Story