A.P. Pharma submits protocol to FDA for APF530 phase 3 trial

By Angela McDaniels

Seattle, Jan. 24 - A.P. Pharma Inc. said it has submitted a protocol to the Food and Drug Administration for a pivotal phase 3 clinical trial that will compare the safety and efficacy of the company's lead product candidate, APF530, with Aloxi (palonosetron) for the treatment chemotherapy-induced nausea and vomiting.

Upon receipt of approval, the company plans to begin enrollment for the trial in April at up to 100 sites.

The proposed phase 3 trial will divide 1,200 patients into two groups: those receiving moderately emetogenic (vomit-inducing) chemotherapeutic agents and those receiving highly emetogenic chemotherapeutic agents. In each group, three sets of patients will be treated with APF530 containing 5 mg or 10 mg of granisetron, compared with the currently approved dose of palonosetron.

The study's primary endpoint is to establish the efficacy of APF530 for the prevention of acute onset (within 24 hours) and delayed onset (four to five days) of nausea and vomiting in patients, A.P. Pharma said.

APF530 contains the anti-nausea drug granisetron formulated with the company's proprietary drug delivery system. The company said APF530 is designed to be administered via subcutaneous injection before chemotherapy and to provide therapeutic plasma levels of granisetron for four to five days.

A.P. Pharma is a specialty pharmaceutical company based in Redwood City, Calif., that develops prescription pharmaceuticals using its proprietary polymer-based drug delivery systems.

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