Solasia Pharma KK has announced that the darinaparsin Phase 2 study patient registration has reached the target number of cases.
The Phase 2 study was a multinational, single-group, open, non-randomized study evaluating the efficacy of darinaparsin monotherapy in patients with relapsed or refractory peripheral T-cell lymphoma ("PTCL") in Japan, Korea, Taiwan, and Hong Kong. And security. Patients received up to 6 cycles of darinaparsin, and efficacy was measured using tumor remission as the primary outcome measure.
Based on previous consultations with administrations, the study was a pivotal (final) study of PTCL treatment. It is currently expected that Solasia will announce the results of the study by 2020.
Solasia holds the exclusive worldwide license to develop and commercialize darinaparsin. In the Japanese market, Solasia has signed an exclusive licensing agreement with Meiji Seika Pharma Co., Ltd. for the commercialization of darinaparsin, and in Latin America, signed a contract with HB Human BioScience SAS. In the future, Solasia will actively seek out authorized partners outside of Asia.
Through the active development of darinaparsin, Solasia will continue to work to provide new treatment options for PTCL patients. In addition, following PTCL, Solasia will continue to seek the possibility of developing other indications in the cancer field.
