Complete ANX-530 Safety Data to be Published in the 2008 Proceedings of the American Society of Clinical Oncology
March 10 2008 - 7:00AM
PR Newswire (US)
SAN DIEGO, March 10 /PRNewswire-FirstCall/ -- ADVENTRX
Pharmaceuticals, Inc. (AMEX:ANX) announced today that complete
safety data from its registrational bioequivalence clinical study
of ANX-530 (vinorelbine emulsion) will be published in the 2008
Proceedings of the American Society of Clinical Oncology (ASCO) in
connection with ASCO's 2008 Annual Meeting, which takes place May
30 - June 3, 2008 in Chicago, IL. The abstract, entitled
"Tolerability and incidence of infusion site reactions with
emulsion formulation of vinorelbine (ANX-530) compared to
vinorelbine solution," will be published. ADVENTRX recently
completed a registrational bioequivalence clinical study of
ANX-530. Pharmacokinetic equivalence, the primary endpoint of the
study, was observed between ANX-530 and Navelbine(R). Furthermore,
in post hoc analyses, ANX-530 demonstrated a statistically
significant reduction in injection site reactions when compared to
Navelbine. ADVENTRX intends to submit to the U.S. Food and Drug
Administration (FDA) in the fourth quarter of 2008 a Section
505(b)(2) NDA for ANX-530. 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. Our
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/
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