· MEDIPOST proved the value of CARTISTEM® by obtaining approval for progressing directly to phase 3 clinical trial, without undergoing phase 1 and phase 2 clinical trials
· The company aims to obtain product approval for Japan’s first knee osteoarthritis cell therapy through one clinical trial
MEDIPOST announced on the 15th that the company has obtained approval from the Ministry of Health, Labour and Welfare of Japan to conduct a phase 3 clinical trial of CARTISTEM® (product name for the clinical trial in Japan: EVA-001).
The purpose of the phase 3 clinical trial is to obtain approval for official product release in Japan. Unprecedentedly, the company has been approved to conduct the phase 3 trial without undergoing phase 1 and 2 trials, as the results of the clinical trials conducted in Korea were accepted. This not only reduces the development costs but also provides an opportunity for the company to quickly enter the Japanese market. Also, MEDIPOST has become the first Korean company to directly enter the phase 3 clinical trial of a cell therapy product in Japan.
The phase 3 clinical trial will evaluate the efficacy and safety of CARTISTEM® in patients with mild to moderate knee osteoarthritis (K&L Grade 2-3). A total of 130 patients will be divided into two groups. After administering one group with CARTISTEM® and the other group with hyaluronic acid, joint function improvement, pain relief, and regeneration of damaged knee cartilage will be compared and analyzed through a 52-week follow-up.
MEDIPOST is also planning to enter the Japanese market with a two-track strategy. Separately from the recently approved phase 3 clinical trial, a phase 2 clinical trial to compare the effects of HTO (High Tibial Osteotomy, a procedure to treat bowlegs (genu varum)) with/without CARTISTEM® in 50 patients with mild to severe knee osteoarthritis (K&L Grade 2-4) is ongoing to obtain conditional product approval since the second half of last year.
Japan has a growing demand for new regenerative drugs such as stem cells. The country is also known to have national medical support services and insurance benefit policies that are well established in the fields of degenerative diseases and regenerative medicine.
An officer of MEDIPOST said, “Japan, along with the United States, has the largest number of knee osteoarthritis patients in the world. From its medical system and business environment, we think it is the best market for increasing the value of CARTISTEM®,” and, “Once we successfully finish the clinical trial and obtain approval for product release, CARTISTEM® will become the first cell therapy for knee osteoarthritis approved in Japan.”
The clinical trial of CARTISTEM® in Japan is being conducted by EVASTEM Co. Ltd., a joint venture in Japan. With the phase 3 clinical trial approval, MEDIPOST plans to actively promote CARTISTEM® in the Japanese market while also forming strategic alliances with Japanese partners for successful clinical trials and commercialization.