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 e
nables 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".