A.P. Pharma Presents APF530 Phase 3 Data at Annual Meeting of the American Society of Clinical Oncology
06/01/2009
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APF530 Data Presented
Preliminary data from the 1,395 patient, multi-center, randomized Phase
3 study were announced in
Below is a summary of the additional data presented in today’s session:
- CR rates for APF530 10 mg dose were generally higher in treatment experienced patients when compared to treatment naïve patients. Additionally, in all instances, CR rates for APF530 in treatment experienced patients were numerically higher than those observed for palonosetron. Based on previous clinical studies, many physicians believe that the risk of CINV increases with each additional cycle of chemotherapy. These new data may suggest potential utility for APF530 in treating patients who have received prior chemotherapy.
- Of the highly emetogenic chemotherapy regimens, those containing cisplatin are considered to be the most troublesome due to their ability to cause significant delayed CINV. The CR rates for patients receiving cisplatin based regimens were numerically higher for APF530 10 mg when compared to palonosetron in both acute and delayed CINV. Specifically, in acute CINV, APF530 had an 81.1% CR rate versus 75.5% for palonosetron, and 66.0% versus 60.4%, respectively, in delayed CINV.
- A pharmacokinetic analysis, conducted in a sub-group of patients, confirmed that a single APF530 10 mg dose successfully maintained blood levels of granisetron for the entire five day period.
Commenting on the results, Nash Gabrail, M.D., of the
A copy of the poster is available in the investor relations section of the Company’s website, at www.appharma.com.
About APF530
About CINV
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 anti-emetic, typically administered just prior to chemotherapy.
Chemotherapy treatments can be classified as moderately emetogenic, meaning that 30% to 90% of patients experience CINV, or highly emetogenic, meaning that more than 90% of patients experience CINV, if they do not receive an anti-emetic. Acute onset CINV occurs within the first 24 hours following chemotherapy treatment. Delayed onset CINV occurs more than 24 hours after treatment and may persist for several days. Prevention of CINV is important because the distress caused by CINV can severely disrupt patient quality of life and can lead some patients to delay or discontinue chemotherapy.
About
Forward-looking Statements
This news release contains "forward-looking statements" as defined by
the Private Securities Litigation Reform Act of 1995. These
forward-looking statements 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
Source:
A.P. Pharma, Inc.
John B. Whelan, 650-366-2626 (Corporate)
Vice
President, Finance and Chief Financial Officer
or
Corporate
Communications Alliance, LLC
Edie DeVine, 209-814-9564
(Investor
and Media Relations)