A.P. Pharma initiates vomiting Phase II clinical trial
A.P. Pharma, of Redwood City, CA, has initiated a Phase II clinical trial programme in cancer patients with its lead product candidate, APF530, for the prevention of both acute and delayed chemotherapy-induced nausea and vomiting.
A.P. Pharma, of Redwood City, CA, has initiated a Phase II clinical trial programme 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 (CINV) following a single subcutaneous injection.
Granisetron is one of a class of 5-HT3 antagonists that have revolutionised 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 $2bn 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 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 multi-centre, 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.
In Phase I studies in healthy human subjects, A.P. Pharma evaluated four dose formulations of APF530. Safety and tolerability data were excellent. The pharmacokinetic results indicated a dose-proportionate increase in plasma levels of granisetron, and meaningful plasma levels were observed over a five-day period. Published data suggest that appropriate plasma levels of granisetron can potentially predict the therapeutic effect on both acute and delayed chemotherapy-induced nausea and vomiting.