A.P. Pharma Initiates APF530 Phase II Trial Program in Cancer Patients
A.P. Pharma has initiated a Phase II clinical trial program in cancer patients with its lead product candidate, APF530, for the prevention of both acute and delayed chemotherapy-induced nausea and vomiting.
Using the company's proprietary Biochronomer bioerodible drug delivery system with granisetron, APF530 is designed to provide therapeutic levels of the drug in order to give four to five days of continuous relief from chemotherapy-induced nausea and vomiting following a single subcutaneous injection.
In the open-label, dose-ascending Phase II trial, patients undergoing moderately emetogenic chemotherapy will receive APF530 containing one of three doses of granisetron. The primary endpoints are pharmacokinetics, safety and tolerability. The trial is a multicenter, active-control study, which will be conducted at various U.S. and international clinical sites and will include at least 30 patients. The first seven U.S. sites selected are in various stages of initiation.
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21Oct