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www.fdanews.com/articles/81304-a-p-pharma-reports-results-from-apf530-trial

A.P. PHARMA REPORTS RESULTS FROM APF530 TRIAL

September 30, 2005

A.P. Pharma has reported results from its APF530 Phase II clinical trial. All clinical endpoints were achieved and results support advancement of APF530 into pivotal clinical trials.

APF530, which contains the antinausea drug granisetron formulated with the company's proprietary Biochronomer bioerodible drug delivery system, is being developed for the prevention of both acute and delayed chemotherapy-induced nausea and vomiting (CINV).

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 in order to prevent CINV during this period. The study was an open-label, dose-ascending trial in patients undergoing chemotherapy for cancer. Patients in the study received an injection of APF530 containing one of three dose-levels of granisetron.