Solasia Pharma K.K. Initiates Phase 2 Study Of Darinaparsin (SP-02) For Peripheral T-Cell Lymphoma

TOKYO--(BUSINESS WIRE)--Solasia Pharma K.K. (Headquarters: Tokyo, Japan, President: Yoshihiro Arai, hereinafter “Solasia”) announced today that an Asian Multinational Phase II study of SP-02 (darinaparsin) for injection (SP-02L) for the treatment of relapsed and refractory peripheral T-cell lymphoma (PTCL) has commenced. This single-arm, open-label, non-randomized study is being conducted in Japan, South Korea, Taiwan and Hong Kong; to evaluate the efficacy and safety of SP-02L monotherapy.

SP-02 is a novel mitochondrial-targeted agent being developed for the treatment of various hematologic and solid cancers. In a US Phase II study, SP-02 demonstrated clinical activity in lymphoma, in particular PTCL. In Phase I studies, in Japan and South Korea, safety and potential efficacy against PTCL have also been demonstrated. Based on the Phase II result, Solasia intends to file for registration in Japan, South Korea, Taiwan and Hong Kong.

Solasia obtained an exclusive worldwide license to develop and commercialize SP-02 from ZIOPHARM Oncology, Inc. (Nasdaq: ZIOP), and the company is currently conducting clinical trials in Japan and other parts of Asia. Solasia granted development and commercialization rights of SP-02 in Japan to Meiji Seika Pharma Co. Ltd.

About Solasia:

Solasia was formed in November 2006 by MPM Capital and ITOCHU Corporation to address unmet needs for important new Western oncology therapies and supportive care products throughout Asia. The company’s mission is to expedite patient access to unique oncology therapies through aggressive development and specialized commercialization throughout Japan, China and other Asian countries. Solasia recently completed Series D financing of JPY2.08 billion in August 2015. The funds will be used to prepare for launch of Sancuso® and further advance clinical development of its existing pipeline. To date, Solasia has raised approximately $80 million in venture financing. Additional information is available at http://www.solasia.co.jp/en/