The Japanese biotech company, JCR Pharmaceuticals, has announced that it has begun clinical trials for the treatment of graft-versus-host disease (GVHD) with its proprietary product, known as JR-031, which consists of a patented preparation of human mesenchymal stem cells derived from bone marrow.
GVHD is a common and potentially fatal complication of allogeneic (in which the donor and recipient are not the same person) bone marrow transplantation, for which a reliable cure has not previously existed. Conventional treatments with corticosteroids which are intended to induce T-cell immune suppression carry a high risk of infection and cancer relapse. Now, however, adult stem cells offer the first actual therapy which has already been shown to halt and reverse GVHD, without imparting further dangers and risks to the patient.
JR-031 uses adult stem cell technology originally developed by the U.S. company Osiris Therapeutics, which is currently in Phase III clinical trials with its human mesenchymal stem cell products in Europe and the U.S., where the therapy has received Fast Track designation from the corresponding regulatory agencies for the treatment of GVHD. In Japan, where Phase I and II clinical trials will be conducted at more than ten hospitals, JCR Pharmaceuticals is developing the therapy in collaboration with the Mochida Pharmaceutical Company. Some patients have already been treated with JR-031, and data should be available within the next few months. If Japan’s Ministry of Health approves JR-031, as expected, this mesenchymal stem cell product will then become the first stem cell-based therapy in Japan. In anticipation of successful clinical trials in Japan, as already demonstrated by the success of clinical trials conducted by Osiris in the U.S. and Europe, JCR Pharmaceuticals and Mochida have already entered into a formal agreement in which both companies will co-develop and commercialize JR-031 for Japan.
JCR Pharmaceuticals is focused on the R&D of human-derived bioactive substances, especially enzyme-, hormone-, and cell-based therapies for orphan diseases. The company was founded in 1975 and is based in Ashiya City, Japan. It is traded on the Osaka Stock Exchange under the symbol JCRPF.