Solasia Announces Initiation of Darinaparsin Injection (SP-02) Phase 1 Study

Solasia Pharma K.K. has announced that enrollment of a Phase I clinical trial evaluating the safety and tolerability of darinaparsin injection (SP-02L) for the treatment of peripheral T-cell lymphoma (PTCL), has commenced in Japan.

Darinaparsin is a novel mitochondrial-targeted agent being developed for the treatment of various hematologic and solid cancers.

In several studies conducted in the US and other countries, darinaparsin injection has demonstrated good tolerability and safety.

In addition, a Phase II study of darinaparsin injection in the US, demonstrated clinical responses in lymphoma, in particular PTCL.

Solasia has an exclusive license from ZIOPHARM Oncology, Inc. to develop and commercialize darinaparsin, in both intravenous and oral forms, across Asia including Japan, China, Hong Kong, Macau, Republic of Korea, Taiwan, Singapore, Australia, New Zealand, Malaysia, Indonesia, Philippines and Thailand.

Solasia also announced it has entered into a collaboration agreement with ACRONET, a leading CRO in Japan, and a wholly-owned subsidiary of ITOCHU Corporation. Both companies will work closely together on the Phase I study of darinaparsin in Japan.

Steven Engen, CEO, commented, “Initiation of this study is an important milestone for Solasia. Based on the attractive profile of darinaparsin, Solasia’s first oncology therapeutic, we believe this drug has the potential to become an important new therapy for patients suffering from lymphoma.”