ADVENTRX to Present Complete ANX-530 Pharmacokinetic Data at the 2008 American Association for Cancer Research Annual Meeting
February 07 2008 - 6:00AM
PR Newswire (US)
SAN DIEGO, Feb. 7 /PRNewswire-FirstCall/ -- ADVENTRX
Pharmaceuticals, Inc. (AMEX:ANX), announced today that complete
pharmacokinetic data from the Company's marketing-enabling
bioequivalence clinical study of ANX-530 (vinorelbine emulsion) has
been accepted for presentation at the 2008 American Association for
Cancer Research (AACR) Annual Meeting, which takes place April 12 -
16, 2008 in San Diego, CA. 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," is scheduled to
be presented on April 13, 2008. ADVENTRX recently completed a
marketing-enabling bioequivalence clinical study of ANX-530. The
primary endpoint in the study was met, with pharmacokinetic
equivalence observed between ANX-530 and the reference drug
Navelbine(R). Furthermore, ANX-530 demonstrated a statistically
significant reduction in injection site reactions when compared to
Navelbine. Presentation of complete safety results including
injection site reactions, have been submitted for presentation at
an upcoming oncology conference. ADVENTRX intends to submit to the
U.S. Food and Drug Administration (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 designed to reduce
the incidence and severity of injection site reactions from
intravenous delivery of vinorelbine tartrate. Vinorelbine tartrate
works by disrupting microtubule formation and is a member of the
vinca alkaloid class of antineoplastic agents. Vinorelbine is
indicated as a single agent or in combination with cisplatin for
treatment of advanced non-small cell lung cancer and has also shown
activity in breast, ovarian, and other cancers. About ADVENTRX
Pharmaceuticals ADVENTRX Pharmaceuticals is a biopharmaceutical
research and development company focused on commercializing
proprietary product candidates for the treatment of cancer and
infectious diseases. The Company seeks to improve the performance
and safety of existing treatments by addressing significant
problems, such as drug metabolism and bioavailability, excessive
toxicity and treatment resistance. 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 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;
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; 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; ADVENTRX's lack of
long-term agreements with suppliers of ANX-530 components and
contract manufacturers of ANX-530, including its inability to
timely secure commercial quantities of ANX-530 or its components on
commercially reasonable terms, or at all; uncertainty under Section
505(b)(2) resulting from legal action against the FDA and the
potential that future interpretations of Section 505(b)(2) could
delay or prevent the FDA from approving any Section 505(b)(2) NDA;
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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