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PrevOnco™ (lansoprazole and DDAIP in combination with doxorubicin for the treatment of Hepatocellular Carcinoma; in discussion for SPA Phase III Trial)

Currently available therapy for hepatocellular carcinoma offers limited efficacy, with the side effects associated with chemotherapy. In vivo and in vitro, PrevOnco™ has demonstrated tumor cell growth inhibition and enhanced survival, alone and in combination with doxorubicin. The FDA has granted PrevOnco™ orphan status. Apricus Bio is currently in discussions with the FDA to finalize the SPA for Phase 3 registration protocol for a comparator study against doxorubicin in patients who have failed treatment with Nexavar^® (the currently marketed first-line anti-cancer treatment for patients with either HCC, or advanced renal cell carcinoma). Patients enrolled will have doxorubicin added to continued therapy with Nexavar^® plus either PrevOnco™ or placebo. Subject to positive data, the Phase 3 study would be expected to support the filing of a New Drug Application for marketing approval in the U.S. and Europe.