South Korea-based Medipost secured FDA agreement to run a single pivotal phase 3 study in the U.S. for Cartistem, the company’s allogeneic cord blood-derived mesenchymal stem cell therapy for knee osteoarthritis.
The agreement lets Medipost lean on its phase 3 data from South Korea and Japan, plus real-world outcomes from roughly 550 Korean patients treated at least three years ago, all of which will be included in the proposed evidentiary package to the FDA as confirmatory evidence to support the anticipated outcome for the U.S. phase 3 study.
"We will leverage the time and cost saving advantages secured through this agreement, together with our successful experience in conducting phase 3 trials both in South Korea and Japan, to ensure the smooth execution of our U.S. Phase 3 study…We are also pleased to partner with the U.S. FDA and appreciate their willingness to show regulatory flexibility to support accelerating novel advanced therapeutic products' entry into the U.S. market," said Antonio Lee, global president, Medipost.
Cartistem has been commercially available in South Korea since 2012, when it became the world's first approved allogeneic hUCB-MSC product. Over 36,000 patients have been treated there. The Japan phase 3, announced earlier this spring, met all primary and secondary endpoints. Medipost has also inked a commercialization license with Teikoku Seiyaku for Japan.
Read more about Medipost and the rise of MSC therapies here.
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