SOLASIA Pharma K.K. Headquarters: Tokyo, President & CEO: Yoshihiro Arai, hereinafter “Solasia”, a specialty pharmaceutical company based in Asia, today announced the positive results from the pivotal Phase 2 study with SP-02 (a new anti-cancer drug, international generic name: darinaparsin, hereinafter “darinaparsin”) for relapsed or refractory peripheral T-cell lymphoma (hereinafter “PTCL”) in Asia.
- The primary endpoint (antitumor effect) was achieved.
- No new safety concerns were identified in the safety analysis.
- This study was conducted as the final registration trial for the indication of relapsed or refractory PTCL.
Solasia begins preparing for the NDA Filing.
Darinaparsin is a novel mitochondrial targeting drug (organic arsenic compound) that has been developed for the treatment of various hematological cancers and solid cancers.
This study was conducted as a multinational, multicentre, single-arm, open-label, non-randomized study to evaluate the efficacy and safety of darinaparsin
monotherapy in relapsed or refractory patients with PTCL in Japan, South Korea,
Taiwan and Hong Kong.
Solasia holds an exclusive worldwide license to develop and commercialize
darinaparsin. For Japan market, Solasia has already entered into an exclusive license agreement with Meiji Seika Pharma Co., Ltd., for the commercialization of darinaparsin, and for Latin America, with HB Human BioScience SAS. Based on these positive results, Solasia will actively seek licensing partners for the United States, Europe and other regions.
– June 15, 2020 @ 18:15 GMT |