A.P. Pharma Completes Enrollment In Phase 3 Trial Of APF530

Main Category: Cancer / Oncology
Also Included In: Clinical Trials / Drug Trials
Article Date: 25 Jun 2008 - 1:00 PDT

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A.P. Pharma, Inc. (NASDAQ:APPA), a specialty pharmaceutical company, has completed patient enrollment in its pivotal Phase 3 study in chemotherapy-induced nausea and vomiting (CINV) comparing the efficacy of APF530 (a proprietary, sustained release formulation of granisetron) with Aloxi for the prevention of acute and delayed onset CINV in both moderate and highly emetogenic chemotherapy treatments. The trial is being conducted in the United States, India and Poland. Data collection will be finalized following completion of treatment of the last patients, expected near the end of July. The results of the trial will be announced following the unblinding of data, which is anticipated to occur late in the third quarter of 2008.

Prevention and control of nausea and vomiting, or emesis, are very important in the treatment of cancer patients. The majority of patients receiving chemotherapy will experience some degree of emesis if not prevented with an antiemetic. Prevention of CINV is significant because the distress caused by CINV can severely disrupt patient quality of life and can lead some patients to discontinue therapy. The unmet need is greatest with patients receiving highly emetogenic chemotherapy, particularly delayed onset CINV, where no drug of APF530's class is currently approved for the prevention of such CINV.

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. Initial target areas of application for the Company's drug delivery technology include anti-nausea, pain management, anti-inflammation and DNA/RNAI applications. For further information visit the Company's web site at http://www.appharma.com.

Forward-looking Statements

This news release contains "forward-looking statements" as defined by the Private Securities Reform Act of 1995. These forward-looking statements, including statements regarding the timing of unblinding and announcing Phase 3 trial data for APF530, involve risks and uncertainties, including uncertainties associated with timely development, approval, launch and acceptance of new products, satisfactory completion of clinical studies, establishment of new corporate alliances, progress in research and development programs and other risks and uncertainties identified in the Company's filings with the Securities and Exchange Commission. We caution investors that forward-looking statements reflect our analysis only on their stated date. We do not intend to update them except as required by law.

A.P. Pharma