REDWOOD CITY, Calif.--(BUSINESS WIRE)--A.P. Pharma, Inc. (NASDAQ:APPA), a specialty pharmaceutical
company, reported today that it believes that it will not meet a
previously announced target of a 2007 filing of its New Drug Application
(NDA) for APF530, currently in a Phase 3 clinical trial. Approximately
80% of the planned 80 clinical sites for the trial are now active.
However, the rate at which sites are being activated continues to be
slower than expected, even following recent renewed efforts to expedite
the approval process. Patient enrollment in the trial continues at a
steady pace, but the anticipated improvements in patient enrollment
rates have also been slower to develop than had been previously forecast.
About APF530 and the Phase 3 Program
APF530, which contains the 5HT3 antagonist
anti-nausea 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 (CINV) in patients undergoing
either moderately or highly emetogenic chemotherapy. No other 5HT3
antagonist is currently approved for the prevention of both acute and
delayed CINV following both moderately and highly emetogenic
chemotherapy.
The APF530 Phase 3 pivotal trial protocol includes a total of
approximately 1,350 patients, about half of which will receive
moderately emetogenic chemotherapeutic agents with the other half
receiving highly emetogenic chemotherapeutic agents. In each group there
will initially be three arms of approximately 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 (brand
name 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 (4-5 days)
CINV in patients receiving either moderately or highly emetogenic
chemotherapy.
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 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 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.
