ANX-530 Demonstrates Equivalent Pharmacokinetics to Navelbine(R) in a Registrational Bioequivalence Clinical Study
April 15 2008 - 7:00AM
PR Newswire (US)
ADVENTRX Presents Data at the 2008 American Association for Cancer
Research Annual Meeting SAN DIEGO, April 15 /PRNewswire-FirstCall/
-- ADVENTRX Pharmaceuticals, Inc. (AMEX:ANX) announced that it
presented pharmacokinetic data from its registrational
bioequivalence clinical study of ANX-530 (vinorelbine emulsion) at
the 2008 American Association for Cancer Research (AACR) Annual
Meeting. The poster presentation, entitled "Pharmacokinetic
equivalence observed between an emulsion formulation of vinorelbine
(ANX-530) and vinorelbine solution in a clinical study of patients
with advanced cancer," was presented by Joachim P.H. Schupp, M.D.,
Vice President of Medical Affairs, on April 13. "ANX-530 is a near
term value-driver for ADVENTRX and we are excited to have met the
primary endpoint in this registrational trial," stated Evan M.
Levine, Chief Executive Officer and President of ADVENTRX. "We are
preparing our New Drug Application (NDA) for ANX-530, which we
anticipate submitting before the end of this year. ANX-530 could be
our first commercially available oncology product and, if approved
by the FDA within its 10 month review goal, may generate revenues
for the company towards the end of 2009." The bioequivalence study
of ANX-530 was a crossover comparison of ANX-530 and Navelbine with
a primary objective of demonstrating the pharmacokinetic
equivalence of ANX-530 and Navelbine. Determining the safety of a
single dose of ANX-530 was a secondary objective. In the first
week, patients were dosed with either ANX-530 or Navelbine, and
after a washout period, were dosed with the opposite drug during
the second week of treatment. Pharmacokinetic equivalence was
demonstrated by a statistical comparison of both the areas under
the curve (AUC) and maximum plasma concentrations (Cmax) and was
determined based on federal regulations and FDA guidance regarding
bioequivalence studies. AUC is a measure of the total amount of the
drug circulating in the body over time. Cmax is the maximum
concentration of the drug measured in the blood at any given time.
If the upper and lower bounds of the AUC ratio's and the Cmax
ratio's 90% confidence interval ranged from 0.80 to 1.25, ANX-530
and Navelbine were considered to have equivalent pharmacokinetics.
The results of a clinical study are actually estimates of what
might be expected if the treatment were to be given to the entire
population of interest. Confidence intervals indicate the precision
of such an estimate. Pursuant to the study's protocol and
statistical analysis plan, data from all 31 patients who received
both study drugs were included in the analysis. A summary of the
pharmacokinetic results is set forth in the following table:
Pharmacokinetic Acceptable Range Parameters ANX-530 Navelbine 90%
Confidence Interval Cmax (ng/mL) 227 223 87-123% 80-125% AUClast
(hr�ng/mL) 758 717 99-112% 80-125% AUCinf (hr�ng/mL) 810 719
100-112% 80-125% Cmax: Maximum plasma concentration AUClast: Area
under the plasma concentration time curve from time zero to the
last time point AUCinf: Area under the plasma concentration time
curve from time zero to infinity Both ANX-530 and Navelbine were
administered via a 10 minute intravenous injection at a dose of 30
mg/m2. Blood samples for pharmacokinetic analysis were collected
prior to the initiation of patient dosing, and, at 10, 20, and 40
minutes after patient dosing, as well as at 1, 3, 6, 24, 48, 72,
and 144 hours after the end of the infusion. Hematology, serum
chemistry, and adverse event reporting were performed throughout
the study period. In post hoc analyses, relative to Navelbine,
ANX-530 demonstrated a statistically significant reduction in
injection site reactions. Notably, the incidence of injection site
reactions attributed to Navelbine was consistent with its product
label. Furthermore, ANX-530 was determined to be safe and
well-tolerated with no significant differences observed in any
other safety parameters. Safety data from the study will be
published in the 2008 Proceedings of the American Society of
Clinical Oncology (ASCO) in connection with ASCO's 2008 Annual
Meeting. ADVENTRX is preparing and intends to submit to the FDA a
Section 505(b)(2) New Drug Application (NDA) for ANX-530 in the
fourth quarter of 2008. About ANX-530 (vinorelbine emulsion)
ANX-530 is a novel emulsion formulation of the chemotherapy drug
vinorelbine. Navelbine, a branded formulation of vinorelbine, is
approved in the U.S. to treat advanced non-small cell lung cancer
as a single agent or in combination with cisplatin, and approved in
the European Union to treat non-small cell lung cancer and advanced
or metastatic breast cancer. Worldwide sales of Navelbine and
generic formulations of vinorelbine in 2006 were in excess of $200
million. Navelbine and its generic equivalents are often associated
with injection site reactions, including phlebitis, erythema and
pain at the site of injection. Studies have shown these reactions
occur in approximately one-third of patients, with 5% of the
reactions categorized as severe. ANX-530 is designed to reduce the
incidence and severity of these injection site reactions.
ADVENTRX's formulation emulsifies vinorelbine into a homogeneous
suspension of nanoparticles that is designed protect the venous
endothelium during administration into a peripheral vein, thereby
reducing irritation associated with administration of the drug.
About ADVENTRX Pharmaceuticals ADVENTRX Pharmaceuticals is a
biopharmaceutical company focused on in-licensing, developing and
commercializing proprietary product candidates primarily for the
treatment of cancer and infectious disease. The Company seeks to
improve the performance and commercial potential of existing
treatments by addressing problems associated with these treatment
regimens. More information can be found on ADVENTRX's web site at
http://www.adventrx.com/. Forward Looking Statement ADVENTRX
cautions you that statements included in this press release that
are not a description of historical facts are forward-looking
statements that involve risks and assumptions that, if they
materialize or do not prove to be accurate, could cause ADVENTRX's
results to differ materially from historical results or those
expressed or implied by such forward-looking statements. These
risks and uncertainties include, but are not limited to: the risk
the FDA will determine that ANX-530 and Navelbine are not
bioequivalent, including as a result of performing pharmacokinetic
equivalence analysis based a patient population other than the
population on which ADVENTRX based its analysis; the risk of
investigator bias in reporting adverse events as a result of the
study's open-label nature, including bias that increased the
reporting of adverse events associated with Navelbine and/or that
decreased the reporting of adverse events associated with ANX-530;
difficulties or delays in manufacturing, marketing and obtaining
regulatory approval for ANX-530, including validating commercial
manufacturers and suppliers and the potential for automatic
injunctions regarding FDA approval of ANX-530 and other challenges
by patent holders during the Section 505(b)(2) process; the risk
that ADVENTRX will be unable to raise sufficient capital to fund
the projects necessary to meet its goals, including funding the
continued development and commercialization of ANX-530; the
potential for regulatory authorities to require additional
preclinical work or other clinical requirements to support
regulatory filings; patent and non-patent exclusivity covering
Navelbine; and other risks and uncertainties more fully described
in ADVENTRX's press releases and periodic filings with the
Securities and Exchange Commission. ADVENTRX's public filings with
the Securities and Exchange Commission are available at
http://www.sec.gov/. You are cautioned not to place undue reliance
on these forward-looking statements, which speak only as of the
date when made. ADVENTRX does not intend to revise or update any
forward-looking statement set forth in this press release to
reflect events or circumstances arising after the date on which it
was made. DATASOURCE: ADVENTRX Pharmaceuticals, Inc. CONTACT:
Investors, Ioana C. Hone of ADVENTRX Pharmaceuticals, Inc.,
+1-858-552-0866 Web site: http://www.adventrx.com/
Copyright
Adventrx (AMEX:ANX)
Historical Stock Chart
From Jun 2024 to Jul 2024
Adventrx (AMEX:ANX)
Historical Stock Chart
From Jul 2023 to Jul 2024