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news.Apricus Biosciences has filed the protocol for a proposed Phase 3 clinical trial of PrevOnco, its proprietary treatment for hepatocellular carcinoma (liver cancer), with the US Food and Drug Administration (FDA).
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The FDA will review the protocol under its Special Protocol Assessment (SPA) program, under which it will give approval for the trial’s design, clinical endpoints and statistical analysis.
Apricus Bio said that the Phase 3 study is expected to take about 12-24 months depending on the recruitment of patients and 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 US.
Apricus Bio’s 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).
In the trial, the subjects will receive Nexavar and doxorubicin (the widely used chemotherapy anti-cancer drug), plus either PrevOnco or a placebo.
Apricus Bio president and CEO Bassam Damaj said that they had seen anti-cancer activity in mice bearing human liver tumors.