Brainstorm Cell Therapeutics Inc. (NASDAQ: BCLI) is set to release Phase 2 clinical study results of its drug candidate NurOwn today. NurOwn is a stem cell based therapy being developed to combat a condition called Amyotrophic Lateral Sclerosis (ALS).
A successful clinical trial of NurOwn could bring Brainstorm closer to commercialization of the product, but a failed study could delay the company’s march to revenue and profitability. Brainstorm had set itself both primary and secondary goals to meet in the study.
According to Brainstorm Cell Therapeutics Inc. (NASDAQ: BCLI), NurOwn contains stem cells that are designed to secrete factors that can repair as well as support damaged neurons in people afflicted by ALS. Patients with ALS condition, which is also known as Lou Gehrig’s disease, are troubled by progressive neuron degeneration that affects the brain and spinal cord.
The Phase 2 study of NurOwn
The Phase 2 study of NurOwn whose results Brainstorm is set to report today enrolled 48 subjects in a randomized, double-blind, placebo controlled program. Of the 48 patients enrolled into the Phase 2 trial of NurOwn, 36 received the therapy while 12 received placebo.
The primary endpoint of the Phase 2 trial was to evaluate the safety of NurOwn based on the count of patients who exhibit adverse events in the course of the treatment. But Brainstorm was also pursuing a secondary goal in the study of the therapy that was to evaluate the change lung function based on the measure of vital capacity.
Brainstorm conducted the study at three U.S. centers.
What is in the report?
Until Brainstorm Cell Therapeutics Inc. (NASDAQ: BCLI) releases the Phase 2 trial data for NurOwn, no one knows exactly what is in the report. However, reviews of the study at the beginning by the independent Data Safety and Monitoring Board (DSMB) showed that it didn’t have any safety issues and that paved the way for the trial to continue. Several months into the study, DSMB conducted its second safety review, which also failed to detect any safety red flags with NurOwn.
Therefore, if DSMB’s assessments are anything to go by, it is safe to conclude that there is a strong case of Brainstorm meeting the primary endpoint of the Phase 2 trial of NurOwn.
Financial performance of Brainstorm Cell Therapeutics Inc. (NASDAQ: BCLI)
Brainstorm Cell Therapeutics Inc. (NASDAQ: BCLI) didn’t generate revenue in 1Q2016, but it logged EPS loss of $0.10 during the quarter.