Kadimastem reports to FDA on results of preclinical ALS treatment studies.
NESS ZIONA, Israel, October 6, 2014 -- Israeli biotechnology company Kadimastem said it has approached the FDA regarding the cellular treatment it is developing for ALS.
In the framework of talks with the FDA, Kadimastem said it will consolidate a preliminary outline for its continuing trials for this indication.
The company reported positive results in a preclinical trial it conducted. In the trial, the efficacy of injecting support cells (astrocytes) produced by the company into the spinal fluid of ALS model mice was tested. This model is highly significant in predicting the treatment's activity in humans.
The results of the trial showed an increased life expectancy in the mice treated, as well as a significant improvement of their motor (muscle) function, compared to the untreated mice. The efficacy of the treatment was also demonstrated in other indices indicating a delay in disease onset.
Injections into the spinal fluid are standard procedure performed routinely in hospitals around the world. The company found that injections into the spinal fluid enable the even dispersion of cells throughout the central nervous system, thereby establishing the method of cell penetration in future treatment of patients.
A company executive said after receiving FDA feedback it will pursue clinical development of the cellular treatment for ALS.
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|Publication:||Stem Cell Business News|
|Date:||Oct 6, 2014|
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