Development Strategy

Solasia is focusing on commercializing assets in the oncology/hematology field, by developing products licensed from western pharmaceutical and biotech companies. Solasia has selected oncology/hematology as its strategic therapeutic area due to the high unmet medical need and fast expanding patient pools in Japan and China. Solasia intends to carry out multinational studies to expedite market approval, and provide valuable medicines to patients in Japan and Asia.

Product in Development

SP-01 (Sancuso®)

Initial indication: Chemotherapy Induced Nausea and Vomiting (CINV)

In May 2008, Solasia acquired rights to SP-01 (Sancuso®) from Strakan International for Japan, China and other countries in Asia.
Sancuso® is an extended release transdermal system, delivering the anti-emetic,granisetron, steadily into the patient’s bloodstream over several days. Transdermal delivery is especially beneficial to patients receiving chemotherapy who cannot swallow medicines due to nausea or mucositis. Clinical guidelines recommend the use of the 5-hydroxytryptamine sub-type 3 (5-HT3) receptor antagonists in the prevention of chemotherapy-induced nausea and vomiting (CINV). Granisetron is a 5-HT3 receptor antagonist with well-established efficacy against CINV.
Sancuso® was approved by the U.S. Food & Drug Administration (FDA) in September 2008 for the prevention of CINV in patients receiving moderately and/or highly emetogenic chemotherapy for up to 5 consecutive days. Besides the U.S., Sancuso®was approved in Korea, the Philippines, Kuwait and Australia.
Solasia has completed a Phase I study in Japanese, and has submitted a Clinical Trial Application (CTA) to the Chinese regulatory agency. Following approval of this CTA,Solasia will carry out a clinical study in China in 2011.

SP-02: Darinaparsin (ZinaparTM, ZIO-101)

Initial indication: Peripheral T-Cell Lymphoma (PTCL)

In March 2011, Solasia acquired rights to SP-02 (darinaparsin) from ZIOPHARM Oncology, Inc. for Japan, China, Korea, Australia and other countries throughout Asia. Darinaparsin is a novel mitochondrial-targeted agent (organic arsenic) being developed for the treatment of various hematologic and solid cancers. In a Phase II study, intravenous darinaparsin demonstrated evidence of clinical activity in lymphoma,and in particular peripheral T-cell lymphoma (PTCL). ZIOPHARM expects to initiate a registration-directed study of darinaparsin in patients with PTCL, likely in the refractory setting, in late 2011.

Darinaparsin was granted Orphan Drug Designation in the U.S. and Europe as a treatment of PTCL and Solasia intends to seek similar status in Japan. ZIOPHARM is also currently studying darinaparsin in combination with CHOP (cyclophosphamide,doxorubicin, vincristine, and prednisone), the current standard of care for front line PTCL, to confirm the tolerability of the combination for a possible future trial in the front-line setting. An oral form is in a Phase I trial in solid tumors.

Development Strategy

Solasia initiated a Japan Phase I study of darinaparsin in 2011 in Japan. Following completion of this trial, Solasia plans to conduct a multinational, pivotal study. In China, preparation of clinical study was just started.