AP Pharma begins trial for treatment of chemotherapy side effects

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 (CINV) following a single subcutaneous injection.

Granisetron is one of a class of 5-HT3 antagonists which have revolutionized the prevention of nausea and vomiting after chemotherapy. Chemotherapy-induced nausea and vomiting is generally classified as either acute or delayed. Acute CINV usually occurs within hours of receiving chemotherapy. The symptoms peak after about 6 hours and last for approximately 24 hours. Delayed CINV occurs 24 hours after administration of chemotherapy and can last for several days.

Granisetron is currently administered by intravenous (IV) injection and is approved for the acute phase only. APF530 is potentially an effective alternative for the prevention of both the acute and delayed phases of CINV in the $2 billion annual market for anti-emetics. Only one product is currently approved for both types of CINV and it is the fastest-growing product in this segment.

In an 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 multi-center, active-control study, which will be conducted at various US and international clinical sites and will include at least 30 patients. The first seven US sites selected are in various stages of initiation.