Kadimastem chose to upgrade the production rooms, for the treatment of ALS patients in the Phase 1 / 2a clinical trial, and adapt them to the stringent European production standards. The production area conforms to the Grade B level GMP (Good Manufacturing Practices) standards, with the actual production being carried out in GMP Grade A level biological hoods. The upgraded rooms have successfully undergone validation and quality assurance certifications. The production process was tested and validated and was approved by the Ministry of Health, thus completing the company’s preparation for the production of the AstroRx® clinical product at a very high quality standard.
The clinical trial is being conducted in the Department of Neurology of the Hadassah Ein-Kerem Medical Center in Jerusalem, and interim results are expected within the coming year.
AstroRx® is an innovative cell-based treatment for ALS, which consists of brain supporting cells (astrocytes), designed to replace the astrocytes whose functionality was damaged in ALS patients. AstroRx® is manufactured by Kadimastem from pluripotent stem cells using a unique technology developed by the company. Currently, there are only two FDA-approved drugs for the treatment of ALS, and they are only able to slightly slow down the progression of the disease. The advantage of AstroRx® is in replacing the patient’s malfunctioning astrocytes with healthy cells. AstroRx® has several mechanisms of action protecting the damaged motor neurons simultaneously, as opposed to currently available treatments which use a single mechanism. The unique properties of AstroRx® are expected to significantly slow down the progression of the disease, as demonstrated by the company in its pre-clinical trials.
Kadimastem (www.kadimastem.com) is a clinical stage biotechnology company that develops industrial regenerative medicine therapies based on differentiated cells derived from Human Embryonic Stem Cells (hESCs) to treat neuro-degenerative diseases such as ALS, as well as Diabetes. The company was founded in August 2009 by Professor Michel Revel and Yossi Ben Yosef, and is traded on the Tel Aviv Stock Exchange (TASE: KDST). The company’s chairman is Dr. Eli Opper, formerly the Chief Scientist of the Israeli Ministry of Industry, Labor and Trade. The company’s investors, in addition to the founders, include Altshuler Shaham Investment House, foreign investors (Julien Ruggieri and Avi Meizler), and additional institutional investors.
Kadimastem was founded based on patent protected technology that was developed at the Weizmann Institute of Science. Based on the Company’s unique platform, Kadimastem is developing technology for regenerative medicine, which repairs and replaces organs and tissue by using functioning cells differentiated from stem cells. The Company focuses on transplanting healthy brain cells to support the survivability of nerve cells as cell therapy for ALS, and transplanting insulin-secreting pancreatic cells for the treatment of insulin-dependent diabetes.