Medipost said Japan's Ministry of Health, Labour and Welfare has approved its phase 2 clinical trial of Cartistem, a stem-cell treatment for knee cartilage defects in patients with osteoarthritis caused by degenerative or recurrent trauma.
|Medipost headquarters in Seongnam, Gyeonggi Province.|
Cartistem is the world's first allogeneic stem cell drug, which won the marketing license from the Ministry of Food and Drug Safety in January 2012.
The trial will randomize 50 patients with mild and severe knee osteoarthritis and compare the safety and efficacy of the therapy by treating patients with a high tibial osteotomy (HTO) alone or a combination of Cartistem and HTO.
The company signed a license-out agreement with Evastem, a Japanese pharmaceutical company, to conduct clinical trials for Cartistem in Japan in May. The milestone fee for this license-out totals $4.5 million and includes a condition to receive a portion of the revenue as a royalty fee at the rate agreed upon for 10 years after obtaining sales approval.
Evastem is a joint venture established by Medipost and Japan's VICX therapeutics. Both companies are responsible for all costs related to the development of the product and the approval process.
"The Japanese clinical trial will be an opportunity to reaffirm the safety and effectiveness of Cartistem, which has been sold in the Korean market for seven years after its launch," a company official said. "In the first half of next year, the company will also apply for phase 3 clinical trials targeting patients who do not need HTO procedures."
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