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news.Apricus Biosciences, a San Diego-based pharmaceutical company, and the US Food and Drug Administration (FDA) are currently in discussions regarding the PrevOnco Special Protocol Assessment (SPA) Phase III protocol submitted in December 2010.
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PrevOnco is Apricus’ proprietary treatment for hepatocellular carcinoma (liver cancer).
It contains lansoprazole, a commonly marketed anti-ulcer compound which shows strong anti-cancer activity in mice bearing human liver tumors.
PrevOnco was granted the orphan drug status in August 2008 by the FDA.
The FDA accepted some of the questions submitted by Apricus and commented on the rest (related to the SPA) in the first set of responses it sent to the latter.
The company’s Clinical Advisory Board, formed to focus on the clinical development of PrevOnco, is scheduled to meet in late February to discuss the FDA response and comments.
Apricus may also request a meeting with the FDA to accelerate the SPA Phase III protocol review process.
The Phase III study is expected to take about 12-24 months once the SPA gets accepted, depending on patient recruitment.
If the trial shows positive results within the SPA agreed-upon parameters, the data would be the foundation for the filing of a new drug application for marketing approval of PrevOnco to treat liver cancer in the US.