Lou Gehrig’s disease patient says treatment helped

Avihai Kremer is the first patient to be treated with Israeli firm Brainstorm Cell’s drug, NurOwn, on the basis of a special approval.

By YAEL GRUNTMAN, GALI WEINREB/ GLOBES
August 4, 2011 23:35
2 minute read.
Pills.

Pills 311. (photo credit: Courtesy)

A patient with amyotrophic lateral sclerosis (ALS, or Lou Gehrig’s disease) has testified to the effectiveness of the stem cell-based treatment for the disease being developed by Brainstorm Cell Therapeutics Ltd.

In a letter obtained by Globes, Avihai Kremer said: “I was diagnosed [with ALS] seven years ago at age 29. Today I am almost completely paralyzed and can’t walk, talk or eat (I use a feeding tube). I am writing this letter using my head. ALS/MND [motor neuron disease] has no effective treatment, and diagnosis means a death sentence even today, a decade into the 21st century.

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“Nevertheless, I was fortunate to be the first to get the stem-cells treatment of Brainstorm Cell Therapeutics two and a half months ago [October 2010] at c in Jerusalem, Israel. The procedure was simple and quick. Within 24 hours I was back home. Two and a half months later, I can testify that the Brainstorm treatment is completely safe and that my condition didn’t deteriorate in that time. In fact, not only did the disease seem to slow/stop in that time period, but preliminary follow-up tests done at Hadassah showed slight improvement in several physical functions such as breathing and speech.”

Kremer is the first patient to be treated with Brainstorm Cell’s drug, NurOwn, on the basis of a special approval. The treatment is not part of the clinical trials that are conducted to establish statistical analyses of a drug’s efficacy and safety. The company is currently conducting a Phase I/II clinical trial of the drug.

Treatment with a drug without US Food and Drug Administration (FDA) or Health Ministry approval of a single patient is an extraordinary procedure, only given in incurable diseases. Such cases are usually handled at the medical center that is also conducting the clinical trial, and the results are not always sent to the company that is developing the drug.

Brainstorm Cell initiated the clinical trial of NurOwn last month and is currently selecting patients for participation.

If the treatment is successful, it could be a historic achievement, as there is no treatment for ALS, and sufferers die within two to five years. However, success in a single patient often cannot be replicated and is statistically meaningless in a clinical trial, and it has no bearing on approval of the drug.

Nonetheless, Kremer’s letter is the first indication of possible success of Brainstorm Cell’s treatment – provided that the clinical trial achieves similar results. A successful treatment opens the $1 billion a year ALS market before the company.

Brainstorm Cell declined to comment on the report.

Brainstorm Cell’s share price closed at $0.44 on Wall Street on Wednesday, giving a market cap of $52.6 million.


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