BrainStorm Cell Therapeutics ALS Data Not As Promising As Press Releases Indicate

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  • Early signals of benefit wane at just 8 weeks.
  • Adverse effects more prominent in treated group.
  • No indication that NurOwn has reversed or even stabilized ALS in phase II data.
  • Phase III will include multiple doses.

BrainStorm Cell Therapeutics (NASDAQ:BCLI) is pursuing a noble and difficult goal, a stem cell based treatment for patients suffering from Amyotrophic Lateral Sclerosis ("ALS"), commonly known as Lou Gehrig's disease as a recognition of one of the disease's most notable victims.

ALS is progressive, debilitating neuromuscular disease that causes a person to become gradually and progressively weaker and is almost always a death sentence. This progressive weakness is due to the degeneration of nerves in the anterior horn of the spinal cord, which transmit information from the brain to the muscles of the body. ALS is a relatively rare disease. According to the Center for Disease Control, about 12,000-15,000 people in the United States have ALS and every year about 5,000 more people are afflicted.

BCLI's ALS therapy is based on its version of autologous mesenchymal stem cells that are grown under proprietary conditions to enhance the cells' production of neurotrophic factors (NTFs). NTFs are growth factors known to support the survival of neurons in a variety of conditions and in animal models of many neurodegenerative diseases. These cells are trademarked under the name, NurOwn. A complete explanation of the production process of NurOwn can be found here.

In July 2016, BrainStorm released Phase II results for its ALS trial where the primary endpoint was safety and tolerability. The trial was not powered to show efficacy. On, the primary endpoint for the trial was stated as: "Number of patients with adverse events [Time Frame: At all study visits: Visit 1 through visit 10]". Although the company announced in its July 18, 2016, press release that the trial met this primary endpoint, it was clear that there were more adverse effects seen in the treated group than in the placebo group. This table from a BrainStorm presentation makes this

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Spent my entire 28 year career on Wall Street with over a decade at Bear Stearns. Over the past decade, I have gained a significant amount of knowledge regarding the stem cell and regenerative medicine sector. My premium service covers this promising subsector of the Biotechnology Sector.Wall Street Titan Research

Disclosure: I/we have no positions in any stocks mentioned, but may initiate a short position in BCLI over the next 72 hours. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article.

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