Ness Ziona, Israel, April 18th 2019, Israeli biotechnology company Kadimastem (TASE: KDST) announced today the approval from the MOH of Israel to continue cell transplantation (AstroRx®) in the five additional ALS patients recruited for Cohort B.
Prior to this stage of the clinical trial, and after receiving the recommendation of the Safety Monitoring Committee (DSMB), the company received approval from the Ministry of Health to move to cohort B. According to the clinical protocol in cohort B, ALS patients will be treated with 2.5 times the number of cells as cohort A. Results for the second experimental group are expected by the end of 2019.
The Phase I / IIa clinical trial is being conducted at the Department of Neurology at the Hadassah Ein Kerem Medical Center and is expected to include 16 patients in addition to the five already treated. The objective of the trial is to examine the safety and efficacy of AstroRx® in ALS patients. Results for patients in cohort A are expected to be reported around the next four months or so. The company is prepared for the continuation of treatment for the next group of patients.
AstroRx® contains healthy and functional astrocyte cells that are designed to protect motor neurons that are affected by ALS patients in several ways. The company's technology enables the injection of AstroRx® cells into the patient's spinal fluid to support damaged cells in the brain and spinal cord, slow progression of the disease, improve the quality of life and life expectancy of the patient.
Mr. Yossi Ben-Yosef, CEO of the company said: "Kadimastem is pleased to receive the approval of the Ministry of Health to move to the next treatment group.”
Prof. Michel Revel, Kadimastem's Chief Scientist commented: "This is another step for the company's progress in the clinical trial of ALS. It confirms the tolerability of the AstroRX® treatment for the first group of patients treated, allowing the trial to continue onto Cohort B for the next stage."