A.P. Pharma reports positive data from Phase 3 study of APF530

1st July 2012 (Last Updated July 1st, 2012 18:30)

A.P. Pharma has reported positive patient-satisfaction data from the Phase 3 study of APF530 in patients with chemotherapy-induced nausea and vomiting (CINV).

A.P. Pharma has reported positive patient-satisfaction data from the Phase 3 study of APF530 in patients with chemotherapy-induced nausea and vomiting (CINV).

The analysis of the subset of data showed that APF530 offered comparable nausea control and patient satisfaction to palonosetron (Aloxi) over a five-day period, with no statistically significant differences.

The MASCC Antiemetic Study Group chair and clinical nurse coordinator, Rebecca A Clark-Snow, said that delayed-onset nausea and vomiting remains a major issue associated with many cancer treatment options, which can affect a patient's quality of life as well as his or her ability to sustain the recommended, potentially lifesaving chemotherapy regimen.

"The data indicate that APF530 has the potential to provide both comparable antiemetic effects and patient satisfaction results to palonosetron."

"In particular, patients who have experienced nausea and vomiting during previous chemotherapy treatments are more susceptible to experiencing a recurrence during subsequent therapy," Clark-Snow added.

"These data indicate that APF530 has the potential to be a promising therapy option for physicians and patients."

The actively controlled, double-dummy, parallel group study stratified patients into two groups, one receiving moderately and the other receiving highly emetogenic chemotherapeutic agents in accordance with the Hesketh algorithm.

APF530 was comparable to palonosetron in preventing both acute- and delayed-onset CINV in patients receiving either moderately emetogenic chemotherapy or highly emetogenic chemotherapy in the multicentre, randomised observer-blind trial.

The severity of nausea experienced by patients in the study was also comparable with no statistically significant differences, according to the company.

A.P. Pharma president and CEO, John Whelan, said the data indicate that APF530 has the potential to provide both comparable antiemetic effects and patient satisfaction results to palonosetron.

"Our continued analysis of the Phase 3 study further demonstrates the potential role APF530 could play as a new therapeutic agent in cancer care," Whelan added.