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news.AP Pharma has submitted a protocol to the FDA for a single pivotal phase III clinical trial with the company's lead product candidate APF530 for the treatment of chemotherapy-induced nausea and vomiting.
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The proposed trial will compare the safety and efficacy of APF530 with MGI Pharma’s Aloxi (palonosetron) for the treatment of acute and delayed chemotherapy-induced nausea and vomiting (CINV) in patients receiving either moderately or highly emetogenic chemotherapy.
The proposed phase III pivotal trial protocol design includes approximately 1,200 patients comprised of two groups, including roughly equal numbers of those receiving either moderately or highly emetogenic chemotherapeutic agents.
AP Pharma’s decision to move into a phase III clinical trial with APF530 is based on positive safety and efficacy data from the open label phase II study of APF530.
APF530 contains the anti-nausea drug granisetron formulated with the company’s proprietary Biochronomer bioerodible drug delivery system. Following a single subcutaneous injection prior to the initiation of chemotherapy, APF530 is designed to provide therapeutic plasma levels of granisetron for four to five days to prevent CINV during this period.