Company to work with Hadassah Medical Center on ALS clinical trial.
NESS ZIONA SCIENCE PARK, Israel, November 2, 2016 -- Israeli biotechnology company Kadimastem (TASE:KDST) has signed a letter of intent with the technology transfer company of the Hadassah Medical Organization for a clinical trial on the company's cell therapy for the treatment of amyotrophic lateral sclerosis (ALS).
The company plans to begin phase 1/2a of the clinical trial (safety and efficacy in humans) in mid-2017, under the supervision of the Israeli Mistry of Health, and following completion of the necessary preparations under the outline coordinated with the FDA.
The trial will include 21 patients and will be conducted by the Department of Neurology of the Hadassah Ein-Kerem Medical Center in Ein Kerem.
Conducting the trial in Israel will allow Kadimastem to benefit from operational efficiency due to the geographic proximity to its manufacturing facility.
Kadimastem's product, AstroRx, is a cell-based treatment for ALS, based on astrocytes produced from stem cells.
The company's technology allows for large scale production of the cells according to Good Manufacturing Practices (GMP) standard.
The astrocytes produced from stem cells can be used as an off-the-shelf product for the treatment of large patient populations worldwide.
The injection of the cells will be performed by means of a standard injection into the spinal fluid, a standard procedure performed routinely in hospitals worldwide.
The company has proven that such injections into the spinal fluid help disperse the cells throughout the central nervous system.
The injection of healthy, functioning astrocytes into the nervous system of ALS patients is expected to provide systemic support for the damaged motor neurons, thereby inhibiting disease progression and improving the patients' life expectancy and quality of life.
The starting material from which the company produced and developed its product is a line of unique human embryonic stem cells created without the use of materials derived from animals, making the line suitable for the treatment of humans.
Performing the clinical trial according to the FDA's outline opens up opportunities for the company for collaborations, exposure to American investors and listing the company for trade on a U.S. stock exchange.
Kadimastem has recruited a regulatory manager for the trial and retained regulatory consultants in Israel and the U.S.
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|Title Annotation:||In The Clinic...|
|Publication:||Stem Cell Research News|
|Date:||Nov 7, 2016|
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