A.P. Pharma: FDA approves protocol for phase 3 clinical trial of APF530 in chemo-induced nausea patients

By E. Janene Geiss

Philadelphia, April 27 - A.P. Pharma, Inc. reported Thursday that the protocol for the phase 3 clinical trial for APF530 has been finalized in cooperation with Food and Drug Administration officials.

The company said it has received approval for the phase 3 protocol for APF530 from the governing review board that is responsible for overseeing the study. Review board approval of the protocol is the final step before initiation of the pivotal study, according to a company news release.

APF530, which contains the 5HT(3) antagonist antinausea drug granisetron formulated with the company's proprietary Biochronomer bioerodible drug delivery system, is being developed for the prevention of acute and delayed chemotherapy-induced nausea and vomiting in patients undergoing either moderately or highly emetogenic chemotherapy for cancer.

No other 5HT(3) antagonist is approved for the prevention of both acute and delayed chemotherapy-induced nausea for both moderately and highly emetogenic chemotherapy, officials said.

"A total of 80 U.S. sites are expected to participate in this study, and the recruitment of investigators is underway," Michael O'Connell, president and chief executive officer, said in the release.

The company said its goal is to complete patient enrollment by the end of this year.

The company is actively seeking potential partners to assist in the development and commercialization of APF530, O'Connell added.

The APF530 phase 3 pivotal trial protocol includes about 1,350 patients with about 675 patients receiving moderately emetogenic chemotherapy agents in one group and about 675 patients receiving highly emetogenic chemotherapeutic agents in another group.

In each group there initially will be three arms of about 225 patients each; two arms will be treated with APF530, high- and low-dose form, and a third arm will be treated with the currently approved dose of palonosetron (Aloxi).

The study's primary endpoint is to establish the efficacy of APF530 for the prevention of acute onset (first 24 hours) and delayed onset (four to five days) of chemotherapy-induced nausea in patients receiving either moderately or highly emetogenic chemotherapy, officials said.

In September 2005, the company reported success in meeting the APF530 phase 2 study endpoints, which included an evaluation of safety, tolerability and pharmacokinetics.

In addition, efficacy endpoints were evaluated relating to emetic events and the use of rescue medication. Analysis of the open-label efficacy data from the phase 2 patient groups receiving either moderately or highly emetogenic chemotherapy indicated that the percentage of complete responders in the moderately emetogenic group was 90% in the acute phase and 78% in the delayed phase.

In the group receiving highly emetogenic chemotherapy, the percentage of complete responders was 81% in the acute phase and 80% in the delayed phase. "Complete response" was defined as no emetic episodes and no use of rescue medication.

A.P. Pharma is a Redwood City, Calif., specialty pharmaceutical company focused on the development of pharmaceuticals using its proprietary polymer-based drug delivery systems.

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