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. 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.About Special Protocol Assessment The FDA's Special Protocol Assessment process was implemented under the Prescription Drug User Fee Act ( PDUFA) in November 1997. The SPA process provides for review and a binding agreement that the Phase III trial protocol design, clinical endpoints, planned conduct and statistical analyses are acceptable to support regulatory approval. About Apricus Biosciences Backed by NexMed, USA and Bio-Quant, Inc., its revenue generating CRO business, Apricus Bio has leveraged the flexibility of its proven NexACT ® drug delivery technology to enable multi-route administration of new and improved compounds across numerous therapeutic classes. Future growth is expected to be driven primarily through out-licensing of this technology for the development and commercialization of such compounds to pharmaceutical and biotechnology companies, worldwide. Concurrently, the Company is seeking to monetize its existing product pipeline, including its approved drug erectile dysfunction treatment, Vitaros ®, as well as compounds in development from pre-clinical through Phase 3, currently focused on dermatology, sexual dysfunction and cancer. For further information on Apricus Bio and its subsidiaries, visit http://www.apricusbio.com. Forward-Looking Statement Safe Harbor Statements under the Private Securities Litigation Reform Act: with the exception of the historical information contained in this release, the matters described herein contain forward-looking statements that involve risks and uncertainties that may individually or mutually impact the matters herein described for a variety of reasons that are outside the control of the Company, including, but not limited to, approval of the proposed SPA, the Company’s capital resources needed to fund any clinical trials, the Company’s ability to replicate pre-clinical study results in subsequent human clinical studies and the rate of patient enrollment in any clinical studies. Readers are cautioned not to place undue reliance on these forward-looking statements as actual results could differ materially from the forward-looking statements contained herein. Readers are urged to read the risk factors set forth in the Company's most recent annual report on Form 10-K and subsequent quarterly reports filed on Form 10-Q. Copies of these reports are available from the SEC's website or without charge from the Company.