A.P. Pharma Initiates APF530 Phase 2 Clinical Trial Program in Cancer Patients
REDWOOD CITY, Calif.--(BUSINESS WIRE)--April 28, 2005--A.P. Pharma, Inc. (Nasdaq:APPA), a specialty pharmaceutical company, today announced the initiation of a Phase 2 clinical trial program 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(TM) 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 which have revolutionized 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 $2 billion 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 2 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-center, active-control study, which will be conducted at various U.S. and international clinical sites and will include at least 30 patients. The first seven U.S. sites selected are in various stages of initiation.
In Phase 1 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.
About A.P. Pharma
A.P. Pharma is a specialty pharmaceutical company focused on the development of ethical (prescription) pharmaceuticals utilizing its proprietary polymer-based drug delivery systems. The Company's primary focus is the development and commercialization of its bioerodible injectable and implantable systems under the trade name Biochronomer(TM). Initial target areas of application for the Company's drug delivery technology include anti-nausea, pain management, inflammation and ophthalmic applications. The Company's product development programs are funded by the sale of common stock in June 2004, royalties from topical products currently marketed by pharmaceutical partners, proceeds from the divestitures of its cosmeceutical and analytical standards product lines and by fees it receives from collaborative partners. For further information visit the Company's web site at www.appharma.com.
Except for historical information, this news release contains certain forward-looking statements that involve risks and uncertainties including, among others, uncertainty associated with timely development, approval, launch and acceptance of new products, establishment of new corporate alliances and progress in research and development programs. Other risks and uncertainties associated with the Company's business and prospects are identified in the Company's filings with the Securities and Exchange Commission. The Company does not undertake to revise these forward-looking statements to reflect events or circumstances occurring in the future.
A.P. Pharma, Inc.
Gordon Sangster, 650-366-2626
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A.P. Pharma, Inc.