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Kadimastem Received a Quick Response from the FDA: The Development Process for the Stem Cell-Based Drug for ALS is Expected to be Significantly Shortened
Oct. 7, 2014
The company reported yesterday on the submission of an initial consulting folder to the FDA and positive results in its first pre-clinical trial for the treatment of ALS
Ness Ziona, Israel, 7 October 2014, Israeli biotechnology company Kadimastem (TASE:KDST) announces today that only one day after approaching the FDA regarding the cellular treatment that it is developing for ALS, an encouraging response was received. Based on the quality of the data presented, the FDA recommends rapidly moving forward in the approval process towards product development and safety (towards clinical trials).
The submission was prepared by the company's development team, accompanied by Gsap, headed by Dr. Sigalit Ariely-Portnoy.
The implication of the detailed response received from the FDA is a decrease in the company's development time and costs.
This type of announcement is unique in the stem cell field, and enables the company to immediately move forward to the next regulatory stage.
Professor Michel Revel, the company's Chief Scientist, noted: "We are very encouraged by the FDA's rapid response, which enables us to approach the next stage of the development of the cellular therapy product for ALS patients faster".
Yossi Ben-Yossef, the company's CEO, noted: "ALS is an incurable disease with no effective treatment available today. The rapid response by the FDA allows us to move forward to the clinical development of a unique embryonic stem cell-based treatment for ALS".
Kadimastem (www.kadimastem.com) (TASE: KDST) uses human stem cells that are differentiated to create medical solutions for diabetes and degenerative diseases of the nervous system and for drug screening. The company’s technological platform enables the differentiation of stem cells into a range of functional human cells, including neuron-supporting cells in the brain as well as pancreatic cells that secrete insulin – beta cells.
Kadimastem relies on technology that was initially invented at the Weizmann Institute in Prof. Michel Revel’s laboratory, and which is now being further developed and advanced in the company’s labs at the Weizmann Science Park. Kadimastem is developing two types of medical applications: A. Regenerative medicine, the purpose of which is to repair and replace tissues and organs damaged by disease using healthy cells grown in laboratory conditions, for example, transplantation of insulin-secreting pancreas cells to treat insulin-dependent diabetes, or transplantation of healthy brain-supporting cells to improve survival of nerve cells and treat ALS; B. Drug screening platforms which use functional human cells and tissues to discover new medicinal drugs.
ALS (Amyotrophic Lateral Sclerosis) is the most severe of a group of neurodegenerative diseases that damage motor neurons, and is incurable. In the United States it is also known as Lou Gehrig's disease, after the American baseball player who was affected by the disease in the 1930s. The disease causes paralysis and death, with average survival after diagnosis of only 2-5 years. Currently, there is no cure or significant drug treatment for ALS, except one drug which prolongs the patient's life only by a number of months. The Ice Bucket Challenge, in which Kadimastem participated, has unprecedentedly raised awareness of the disease worldwide.