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.
SOURCE ADVENTRX Pharmaceuticals, Inc.
 back to top
Related links:
http://www.adventrx.com
CONTACT:
Investors, Ioana C. Hone of ADVENTRX
Pharmaceuticals, Inc., +1-858-552-0866
|
