While BrainStorm Cell Therapeutics (OTCBB:BCLI) is expected to officially release their highly anticipated clinical data to U.S. investors shortly, two widely distributed overnight reports point to strong progress in the results of their mid-stage clinical trials. (UPDATE: The company has now reported "Outstanding ALS Interim Clinical Trial Results")
Israel-based BrainStorm is developing NurOwn for the treatment of Lou Gehrig's disease (Amyotrophic Lateral Sclerosis) and while the trials, were designed primarily as studies looking at patient safety, there appear to be some definitive clear efficacy results which have investigators and the ALS medical community excited by what they see.
Over the weekend, Andrew Jack, a reporter from the Financial Times in London wrote that the results give "a fresh boost to the fledgling stem cell sector."
"Although this was not the main aim of the test, some of the 12 patients in the phase 1/2 trial with Amyotrophic Lateral Sclerosis (ALS), the muscle-wasting disease, as well as three further patients provided with the experimental treatment, also showed highly unusual signs of improvement, the company said."
A second report, which appears in the Chicago Tribune via Reuters, points out:
"It's very uncommon to give at such an early point in a clinical study efficacy data, but we cannot ignore the fact on an individual basis we could see improvement in many of the patients involved, each one in different areas," Moshe Neuman, CEO of Biomedical Research Design, which serves as a contract research organization for the trial, said.
"In some patients breathing improved, in others it was muscle strength and in others it was speech, he told Reuters.
"Neuman said a final report was expected by the end of the year after each patient has been observed for nine months."
Amyotrophic lateral sclerosis (ALS), often referred to as "Lou Gehrig's Disease," is a progressive neurodegenerative disease that affects nerve cells in the brain and the spinal cord. Motor neurons reach from the brain to the spinal cord and from the spinal cord to the muscles throughout the body. The progressive degeneration of the motor neurons in ALS eventually leads to their death. When the motor neurons die, the ability of the brain to initiate and control muscle movement is lost. With voluntary muscle action progressively affected, patients in the later stages of the disease may become totally paralyzed.
"In one patient in particular, Rabbi Rafael Shmuelevitz of Jerusalem, significant improvement was seen," wrote Tova Cohen or Reuters. "Shmuelevitz, who in addition to ALS also has a neuromuscular disease called myasthenia gravis, was received as a compassionate patient and given a higher dose than other patients."
A recently televised report featured Rabbi Shmuelevitz's breakthrough case as the first ever scientifically documented reversal of the degenerative symptoms from ALS.
Early last week, we told our premium subscriibers that Brainstorm's upcoming data might provide a good catalyst for a trade.
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