MEDIPOST, a developer of allogeneic stem cell therapy products, is accelerating its entry into Japan.
MEDIPOST announced on the 9th that the Ministry of Health, Labor and Welfare(MHLW) of Japan has approved the Phase II clinical trial of CARTISTEM® for knee osteoarthritis.
In this trial, 50 patients with mild to severe knee osteoarthritis (K & L grades 2 to 4) will be randomly assigned, in one-to-one ratio, either to the control group or CARTISTEM® treatment group.
The control group of subjects will undergo HTO (High/Proximal Tibial Osteotomy) alone, while the CARTISTEM® group will be treated with both HTO and CARTISTEM®. The two groups will be compared for safety and efficacy evaluations.
MEDIPOST, on the 5th of this month executed a license agreement with EVASTEM Co., Ltd. for clinical development of CARTISTEM® in Japan.
The combined milestone-based license fee for this license-out agreement stands at USD$4.5 million, with running royalty income as a portion of the revenue, payable to MEDIPOST at an agreed rate for up to 10 years following product approval in Japan.
EVASTEM Co. Ltd. is a joint venture company with 50% ownership by MEDIPOST and 50% by Japan’s VICX Therapeutics Co., Ltd., and is responsible for the clinical development and approval of CARTISTEM® by the regulatory authorities in Japan.
Prior to the clearance of clinical trial approval, a group of Japanese orthopedic surgeons who will participated in the Japanese clinical trial, arrived in Korea on the 29th of last month for the preparation of the clinical trial in Japan.
The visiting group included EVASTEM officials and orthopedic surgeons who held discussions with Korean orthopedic surgeons and additional regular visits with more Japanese orthopedic surgeons will be scheduled starting from next year as the clinical trial is initiated.
A MEDIPOST official said, “Japanese clinical trial will be a chance to re-affirm the safety and efficacy of CARTISTEM®, which has been marketed for the past 7 years after receiving market approval in Korea,” and added that “in the first half of next year, we will also apply for Phase III clinical trial in Japan, targeting patients who do not require HTO procedure concomitantly.”