What's In Store For BCLI: A Smooth Sailing Or Perfect Storm?

(RTTNews) - BrainStorm Cell Therapeutics Inc. (BCLI) will be announcing top line results from the U.S. phase II study of its investigational cell therapy NurOwn in patients with Amyotrophic Lateral Sclerosis today (July 18, 2016).

The company will host a conference call and webcast with slides at 10:00am Eastern Time.

Amyotrophic lateral sclerosis, often referred to as "Lou Gehrig's Disease, is a progressive fatal neurodegenerative disease that affects nerve cells in the brain and the spinal cord, causing muscle weakness, paralysis, and ultimately, respiratory failure.

Currently, there is only 1 approved drug for treating amyotrophic lateral sclerosis, and that is Riluzole, available under the brand name Rilutek and in generic versions, which is said to extend survival by only about 2 to 3 months.

Brainstorm's NurOwn consists of autologous mesenchymal stem cells that have been induced to secrete neurotrophic factors to support and repair damaged neurons.

The phase II trial of NurOwn in patients with Amyotrophic Lateral Sclerosis in the U.S. was started in June of 2014, and it completed enrollment last August - reaching the targeted enrollment of 48 subjects.

The primary endpoint of the study is safety, and secondary endpoints are efficacy measures including the ALS Functional Rating Scale (ALSFRS), slow vital capacity (SVC), and grip strength.

Would NurOwn have hit the goals in the trial? Well... we'll have to wait a few more hours to find out.

Preparations are underway by the company to conduct a phase II multi dose trial with NurOwn in Amyotrophic Lateral Sclerosis at the Hadassah Medical Center in Jerusalem. The trial is expected to enroll up to 24 patients who will receive three consecutive stem cell transplantations in order to explore the safety and efficacy of a multi dose treatment.

BCLI touched a 52-week high of $3.87 on Friday, before closing the day's trading at $2.99, down 16.01%.