Towards The Company's First Clinical Trial; Kadimastem Signs Letter Of Intent With Hadassah Medical Center For Performance Of The Clinical Trial In ALS
Israeli biotechnology company Kadimastem (TASE: KDST) announced today that it has signed a letter of intent with Hadasit Medical Research Services & Development Ltd., the technology transfer company of the Hadassah Medical Organization, for the performance of the clinical trial on Kadimastem's cell therapy product for the treatment of ALS.
The Company plans to begin phase I/IIA of the clinical trial (safety and efficacy in humans) in mid-2017, under the supervision of the Israeli Mistry of Health, and following completion of the necessary preparations under the outline coordinated with the FDA. The trial will include 21 patients and will be conducted by the Department of Neurology of the Hadassah Ein-Kerem Medical Center in Ein Kerem, a world-leading center in the field of ALS. Conducting the trial in Israel will allow Kadimastem to benefit from operational efficiency due to the geographic proximity to its manufacturing facility.
Kadimastem's product, AstroRx® is a cell-based treatment for ALS, based on astrocytes produced from stem cells. Kadimastem's unique technology allows for large scale production of the cells according to Good Manufacturing Practices (GMP) standard. The astrocytes produced from stem cells can be used as an off-the-shelf product for the treatment of large patient populations worldwide. The injection of the cells will be performed by means of a standard injection into the spinal fluid, a standard procedure performed routinely in hospitals worldwide. The company has proven that such injections into the spinal fluid help disperse the cells throughout the central nervous system. The injection of healthy, functioning astrocytes into the nervous system of ALS patients is expected to provide systemic support for the damaged motor neurons, thereby inhibiting disease progression and improving the patients' life expectancy and quality of life. The starting material from which the Company produced and developed its product, is a line of unique human embryonic stem cells, developed in the laboratory of Prof. Benjamin Reubinoff from Hadassah Hospital, without the use of materials derived from animals and according to GMP standard, such that they will be suitable for the treatment of humans. The cells were received under license from Hadasit.
Yossi Ben-Yossef, the company's CEO, noted, "The first clinical trial is an extremely significant milestone for the company. In light of the regulatory easements in East Asia, and in order to accelerate the commercialization and distribution of the ALS product, Kadimastem is considering collaborations with pharmaceutical companies and other partners in this region. Performing the clinical trial according to the FDA's outline opens up opportunities for the company for collaborations, exposure to American investors and listing the company for trade on a US stock exchange. Kadimastem is preparing for the start of the trial and has recruited a regulatory manager and retained first-rate regulatory consultants in Israel and the US."
Prof. Michel Revel, the company's Chief Scientist, added, "This is a very significant step in the development of Kadimastem's product for the treatment of ALS. We are happy about the collaboration with the distinguished Hadassah Medical Center, and in particular with Prof. Tamir Ben Hur, head of the Neurology Department and Dr. Marc Gotkine, the director of the ALS clinic."
Dr. Tamar Raz, CEO of Hadasit, noted, "We are proud that the starting material, which originated in Hadassah Hospital, has been developed and matured to a clinical trial product by Kadimastem, a company with which we have excellent cooperation. The ALS clinic in Hadassah in which the trial will be conducted is a global leader, and is experienced in recruiting patients for cell therapy."
ABOUT ALS
ALS (Amyotrophic Lateral Sclerosis) is the most severe of a group of neurodegenerative diseases that damage motor neurons, and control most of the muscles in the body. The destruction of these neurons causes complete paralysis of the muscles they control. Currently, the disease is incurable and there is no significant drug treatment available. In recent years, there is growing evidence that in ALS patients, the ability of nervous system support cells (astrocytes) to maintain a supporting microenvironment for motor neurons is impaired.
ABOUT KADIMASTEM
Kadimastem is a biotechnology company, operating in the field of regenerative medicine - a groundbreaking field in which the malfunctioning of organs which leads to diseases is repaired by external cells, tissues or organs. The company specializes in the development of human stem cell-based medical solutions for the treatment of diabetes and neurodegenerative diseases, such as ALS and Multiple Sclerosis. The company was founded in August 2009 by Professor Michel Revel and Yossi Ben Yossef, and is traded on the Tel Aviv Stock Exchange (TASE: KDST). Kadimastem employs 36 people, of which 12 are PhDs, and its 1,700m2 offices and labs are located in the Ness Ziona Science Park.
Kadimastem was founded based on patent protected technology that was developed at the Weizmann Institute of Science, in Prof. Michel Revel's laboratory. Prof. Revel, who serves as the company's Chief Scientist and director, developed Merck KGaA's blockbuster drug, Rebif® for the treatment of MS (sales of around $2.4 billion sales in 2014).
Based on the company's unique platform, Kadimastem is developing two types of medical applications: A. 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; B. Drug screening platforms, which use functional human cells and tissues to discover new medicinal drugs. The company has two collaboration agreements with leading global pharmaceutical companies.
The company is headed by Yossi Ben-Yossef, an entrepreneur with extensive experience in life sciences companies. The company's chairman is Dr. Eli Opper, formerly the Chief Scientist of the Israeli Ministry of Industry, Labor and Trade, and its investors include Altshuler Shaham Investment House, foreign investors (Julien Ruggieri and Avi Meizler), and the company's founders.
Kadimastem has an extensive scientific advisory board, featuring prominent scientists and pioneers: in the embryonic stem cells field, Professor Benjamin Reubinoff and Professor Joseph Itskovich, in the neurodegenerative disease field, Professor Tamir Ben-Hur, and in the diabetes field, Professor Shimon Efrat and Professor Eddy Karnieli.
Contact:
Kadimastem
Yehuda Feinberg
+972-73-7971600
y.feinberg@kadimastem.com