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Apricus Biosciences Inc. (APRI) Files Protocol for Liver Cancer Treatment with U.S. FDA

Apricus Biosciences uses its NexACT drug delivery technology for therapeutic purposes, with a primary focus on monetizing its existing product pipeline, including its approved drug erectile dysfunction treatment, Vitaros. The company is also developing compounds pre-clinical through phase III, currently focused on dermatology, sexual dysfunction and cancer.

The company today announced its U.S. FDA filing for the protocol of a proposed phase III clinical trial of PrevOnco™, the company’s proprietary treatment for liver cancer. The FDA granted PrevOnco Orphan Drug status in August 2008.

The FDA will review the protocol under its Special Protocol Assessment (SPA) program, which evaluates the trial’s design, clinical endpoints and statistical analysis. The phase III study is expected to take between one and two years, contingent on the company’s enrollment of patients. If the study demonstrates positive results according to the guidelines of the SPA, the company will move forward with the filing of a New Drug Application for marketing approval of PrevOnco in the U.S.

PrevOnco incorporates lansoprazole, which is commonly used as an anti-ulcer compound, which the company says has shown strong anti-cancer activity in mice bearing human liver tumors, demonstrating its potential as treatment for humans.

“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,” Dr. Bassam Damaj, president and CEO of Apricus Bio stated in the press release.

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