Full Press Release Details
A.P. Pharma Announces Study Finding Continuous Exposure to a
Antagonist Using APF530 Provides Better Emetic Control
Phase 3 Data Abstract Accepted by American Society of
Clinical Oncology for
Publication at Annual Meeting
REDWOOD CITY, Calif. May 31, 2012 A.P. Pharma, Inc. (OTCBB: APPA.OB), a specialty pharmaceutical company, today announced that an abstract
analyzing a subset of efficacy results from its Phase 3 trial of APF530 has been published in conjunction with the American Society of Clinical Oncology s (ASCO) 2012 Annual Meeting. APF530 is the Company s lead product candidate being
developed for the prevention of both acute- and delayed-onset chemotherapy-induced nausea and vomiting (CINV). The abstract concludes that continuous exposure to a 5-HT3 receptor antagonist, through the administration of an extended-release
formulation such as APF530, results in better emetic (nausea and vomiting) control than administration of a standard, short-acting 5-HT3 receptor antagonist. The title of the abstract is:
The effect of continuous exposure to serotonin receptor antagonism on delayed emesis: An analysis of 1,535 patients in two randomized
clinical trials with granisetron (G), APF530, and palonosetron (palo).
Abstract No.: e19635
Authors: Harry Raftopoulos, Erin O Boyle, Richard J. Gralla, Martin Rosenberg, John Barr
The full abstract is available on the ASCO website, here.
A.P. Pharma s lead product, APF530, is in
development for the prevention of both acute-onset and delayed-onset chemotherapy-induced nausea and vomiting (CINV). APF530 contains the 5-HT3 antagonist, granisetron, formulated in the Company s proprietary Biochronomer drug delivery system, which allows therapeutic drug levels to be maintained for five days with a single
subcutaneous injection. Intravenous and oral formulations containing granisetron are approved for the prevention of acute-onset CINV, but not delayed-onset CINV. Granisetron was selected because it is widely prescribed by physicians based on a
well-established record of safety and efficacy.
A.P. Pharma is a specialty pharmaceutical company developing products using its proprietary Biochronomer polymer-based drug delivery technology. The Company s primary focus is on its lead product, APF530, for the
prevention of CINV. A.P. Pharma received a Complete Response Letter on the APF530 NDA and is targeting the resubmission of the NDA in mid-2012. The Company has additional research and
development programs that utilize its bioerodible, injectable and implantable delivery systems. For further information, please visit the Company s web site at www.appharma.com.
Mobile Phone: 917-282-3242
Email: mrice@lifesciadvisors.com
John B. Whelan, President, Chief Executive Officer and Chief Financial Officer
Office Phone: 650-366-2626