Japan-based Solasia Pharma has started an Asian Multinational Phase II trial of SP-02 (darinaparsin) for injection (SP-02L) to treat relapsed and refractory peripheral T-cell lymphoma (PTCL).
The trial is designed to evaluate the efficacy and safety of SP-02L monotherapy, and is being carried out in Japan, South Korea, Taiwan and Hong Kong.
SP-02 is a new mitochondrial-targeted agent being developed to treat various hematologic and solid cancers.
The company noted that in a US Phase II trial, SP-02 showed clinical activity in lymphoma, in particular PTCL.
Safety and potential efficacy against PTCL have also been demonstrated in a Phase I trial carried out in Japan and South Korea.
Based on the Phase II result, the company plans to file for registration in Japan, South Korea, Taiwan and Hong Kong.
The Japanese firm secured an exclusive worldwide licence to develop and commercialise SP-02 from Ziopharm Oncology.
The company aims to accelerate patient’s access to oncology therapies through development and specialised commercialisation across Japan, China and other Asian countries.
Last August, the company provided Series D financing of JPY2.08bn ($18.3m) for the launch of Sancuso and further advance clinical development of its existing pipeline.
