REDWOOD CITY, Calif. & ORLANDO, Fla.--(BUSINESS WIRE)--Jun. 1, 2009--
A.P. Pharma, Inc. (Nasdaq:APPA), a specialty pharmaceutical company,
today announced additional findings from the Company’s Phase 3 study of
APF530 for the prevention of chemotherapy-induced nausea and vomiting
(CINV). The new data were included in a poster presentation during the 45th
Annual Meeting of the American Society of Clinical Oncology (ASCO).
APF530 is a long-acting formulation of granisetron that utilizes the
Company’s proprietary Biochronomer™ drug delivery system. The Company
filed a new drug application (NDA) for APF530 in May 2009.
APF530 Data Presented
Preliminary data from the 1,395 patient, multi-center, randomized Phase
3 study were announced in September 2008. The results demonstrated that
complete response (CR) rates for APF530 10 mg dose were non-inferior to
palonosetron (Aloxi®) during acute CINV (0 to 24 hours) following
moderate or highly emetogenic chemotherapy and also during delayed CINV
(24 to 120 hours) following moderately emetogenic chemotherapy. In
addition, the CR rate observed for APF530 in delayed CINV following
highly emetogenic chemotherapy was comparable to palonosetron. APF530
was generally well tolerated, with a side effect profile consistent with
previous human use of granisetron and consisting primarily of
constipation and headaches. Both the rate and severity of systemic side
effects were similar between the APF530 and palonosetron arms of the
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
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 Gabrail Cancer
Center and an investigator in the Phase 3 study stated “Delayed onset
nausea and vomiting remains a major problem in the treatment of cancer,
which can affect not only the patient’s quality of life but also his or
her ability to continue receiving potentially lifesaving chemotherapy. I
believe physicians will welcome APF530 as a possible new addition to the
treatment armamentarium for this serious unmet need.”
A copy of the poster is available in the investor relations section of
the Company’s website, at www.appharma.com.
A.P. Pharma's lead product candidate, APF530, is being developed for the
prevention of both acute and delayed onset chemotherapy-induced nausea
and vomiting (CINV). APF530 contains the 5-HT3 antagonist, granisetron,
formulated in our proprietary Biochronomer™ drug delivery system, which
allows therapeutic drug levels to be maintained for five days with a
single subcutaneous injection. Injections and oral tablets containing
granisetron are approved for the prevention of acute onset CINV, but not
for delayed onset CINV. Granisetron was selected because it is widely
prescribed by physicians based on a well-established record of safety
and efficacy. In September 2008, A.P. Pharma reported positive top-line
results from its pivotal Phase 3 study. In this multi-center, randomized
trial that enrolled 1,395 cancer patients, APF530 was shown to be
equally as effective as (statistically non-inferior to) palonosetron
(Aloxi®) in the prevention of both acute onset and delayed onset CINV.
An NDA for APF530 was submitted in May 2009. Palonosetron is the only
injectable 5-HT3antagonist FDA-approved for the prevention
of delayed onset CINV. APF530 was also generally well-tolerated in this
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 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 A.P. Pharma
A.P. Pharma is a specialty pharmaceutical company developing products
using our proprietary Biochronomer™ polymer-based drug delivery
technology. Our primary focus is on our lead product candidate, APF530,
which has completed a pivotal Phase 3 clinical trial for the prevention
of CINV. An NDA for APF530 was submitted in May 2009. The Company has
additional clinical- and preclinical-stage programs in the area of pain
management, all of which utilize its bioerodible injectable and
implantable delivery systems. For further information, please visit the
Company's web site at www.appharma.com.
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 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.
Source: A.P. Pharma, Inc.
A.P. Pharma, Inc.
John B. Whelan, 650-366-2626 (Corporate)
President, Finance and Chief Financial Officer
Communications Alliance, LLC
Edie DeVine, 209-814-9564
and Media Relations)