Ness Ziona, Israel, 24 February 2019, Israeli biotechnology company Kadimastem (TASE: KDST) announced today the completion of cell transplantation (AstroRx®) in 5 patients who were enrolled in Cohort A for its clinical trial in ALS.
In preparation for this stage of the clinical trial the company has recently hired a production manager with many years of experience in the field of clinical production. The company has also upgraded the production system, increased its QA and production teams, and invested considerable resources in improving the production process.
The phase I/IIa clinical trial is being conducted by the Department of Neurology of the Hadassah Ein-Kerem Medical Center, and it is expected to include a total of 21 patients. The objective of the trial is to evaluate the safety and efficacy of AstroRx® in patients. Results for Cohort A of the trial are expected within around half a year. The company is prepared for the next cohort of patients and is expecting to receive MOH approval by April 2019.
AstroRx® contains functional healthy astrocytes (nervous system support cells) derived from human embryonic stem cells that aim to protect ALS-diseased motor neurons through several mechanisms. The company's technology enables the injection of AstroRx® cells into the patient's spinal fluid with the goal of supporting the malfunctioning cells in the brain and spinal cord, slowing the progression of the disease and improving the patient's quality of life and life expectancy.
Mr. Yossi Ben-Yosef, CEO of the company said: "I am proud of the professional and dedicated work of the Kadimastem team. Providing treatment to 5 patients is an important milestone in the progress of the trial. A great deal of effort has been invested in reaching this point and we are looking forward to continuing to provide treatment to additional patients."
Prof. Michel Revel, Kadimastem's Chief Scientist commented: "I am pleased with the progress of the clinical trial thanks to the professional organization of the drug production system in the company's clean rooms. The continued data collection of neurologic data in ALS patients before and after treatment will allow us in the near future to evaluate the results of the first group of patients."