Apricus files protocol of PrevOnco Phase 3 clinical trial for FDA SPA program

Nov 23 2010

Apricus Biosciences, Inc., ("Apricus Bio") (Nasdaq: APRI) today announced that it has filed the protocol for a proposed Phase 3 clinical trial of PrevOnco^™, its proprietary treatment for hepatocellular carcinoma (liver cancer), with the U.S. Food and Drug Administration (FDA). The FDA will review the protocol under its Special Protocol Assessment (SPA) program, under which the FDA would give approval for the trial's design, clinical endpoints and statistical analysis. The Phase 3 study is expected to take about 12-24 months depending on the recruitment of patients. If the trial shows positive results within the parameters agreed upon in the SPA, the data would then be expected to provide the basis for the filing of a New Drug Application for marketing approval of PrevOnco in the U.S.

“Fifteen years worth of experience using lansoprazol to treat ulcers has shown that the drug is safe for human use. We have also seen strong anti-cancer activity in mice bearing human liver tumors. As a result, we are optimistic that PrevOnco to do well in the clinic.”

The FDA granted PrevOnco Orphan Drug status in August 2008. The product incorporates lansoprazole, a commonly marketed anti-ulcer compound which has shown strong anti-cancer activity in mice bearing human liver tumors. The Phase 3 study will enroll up to 218 patients who have advanced, unresectable hepatocellular carcinoma who no longer respond to Nexavar^® (the currently marketed first-line anti-cancer treatment for patients with this type of liver cancer). The subjects will receive Nexavar and doxorubicin (the widely used chemotherapy anti-cancer drug), plus either PrevOnco or a placebo. Nexavar is marketed in the U.S. by Onyx Pharmaceuticals, Inc. and Bayer HealthCare Pharmaceuticals, Inc., with close to $1 billion in sales, and is approved in more than 90 countries for the treatment of patients with hepatocellular carcinoma.

Dr. Bassam Damaj, President and Chief Executive Officer of Apricus Bio, noted, "Fifteen years worth of experience using lansoprazol to treat ulcers has shown that the drug is safe for human use. We have also seen strong anti-cancer activity in mice bearing human liver tumors. As a result, we are optimistic that PrevOnco to do well in the clinic."

In addition, the Company has developed a new, oral lansoprazole formulation incorporating its clinically validated, proprietary NexACT^® drug delivery technology, which is designed to potentially reduce the lansoprazole dose needed in humans by seven times, based on data generated in non-human primate studies. The Company may seek FDA approval to switch the current lansoprazole formulation with the NexACT formulation of lansoprazole following a Phase I human pharmacokinetic equivalency bridging study.