- ANX-530 Demonstrates Statistically Significant Reductions in Selected
Safety Observations
- Abstract to be published in 2008 Proceedings of the American Society of
Clinical Oncology
SAN DIEGO, May 16 /PRNewswire-FirstCall/ -- ADVENTRX Pharmaceuticals,
Inc. (Amex: ANX) announced today that, in a registrational bioequivalence
clinical study, ANX-530 demonstrated a statistically significant reduction
in general disorders and administration site conditions when compared to
Navelbine(R) (p=0.014). In addition, in post hoc analyses, ANX-530
demonstrated a statistically significant reduction in injection site
reactions when compared to Navelbine (p<0.01). ANX-530 was determined
generally to be safe and well-tolerated.
Detailed safety data from the registrational bioequivalence clinical
study is available on the website of the American Society of Clinical
Oncology (ASCO) at http://www.asco.org. The abstract, entitled
"Tolerability and incidence of infusion site reactions with emulsion
formulation of vinorelbine (ANX-530) compared to vinorelbine solution,"
will be published in the 2008 Proceedings of the American Society of
Clinical Oncology in connection with ASCO's 2008 Annual Meeting, which
takes place May 30 - June 3, 2008 in Chicago, IL.
"We are encouraged by these data and pleased that our goal to improve
the safety of vinorelbine has been observed in the clinic," stated Evan M.
Levine, Chief Executive Officer and President of ADVENTRX. "The improvement
in injection site reactions could translate into a real benefit for
patients as well as healthcare practitioners."
A summary of all reported general disorders and administration site
conditions is set forth in the following table:
System Organ Class/Preferred Term ANX-530 Navelbine P value
General Disorders and Administration Site
Conditions 5 14 0.014
Infusion Site Phlebitis 1* 7 -
Asthenia 3 3 -
Fatigue 1 1 -
Infusion Site Irritation 0 1 -
Infusion Site Pruritis 0 1 -
Pyrexia 0 1 -
* One event of infusion site phlebitis was excluded based on its proximity
to an additional dose of Navelbine administered during the study's
follow up period.
A summary of post-hoc analyses regarding injection site reactions is set
forth in the following table:
ANX-530 Navelbine P value
Injection Site Reactions 1 9 <0.01
Infusion Site Phlebitis 1 7 0.03
Infusion Site Irritation 0 1 -
Infusion Site Pruritis 0 1 -
General disorders and administration site conditions denotes the
system/organ/class MedDRA term. Injection site reactions consist of all
grades of investigator-reported phlebitis, irritation and pruritus, in each
case at the site of injection. Adverse events were graded based on the
investigator's assessment of severity.
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, the primary endpoint of the study,
was observed between ANX-530 and Navelbine.
ADVENTRX intends to submit to the U.S. Food and Drug Administration
(FDA) a Section 505(b)(2) NDA for ANX-530 around the end 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. The Company'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, obtaining
regulatory approval for and marketing ANX-530, including validating
commercial manufacturers and suppliers and the potential for automatic
injunctions regarding FDA approval of ANX-530; 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.
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Related links:
http://www.adventrx.com
CONTACT:
investors, Ioana C. Hone of ADVENTRX
Pharmaceuticals, Inc., +1-858-552-0866
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