SAN DIEGO, Nov. 16 /PRNewswire-FirstCall/ -- ADVENTRX Pharmaceuticals,
Inc. (Amex: ANX) today announced positive results from its
marketing-enabling clinical study of ANX-530 (vinorelbine emulsion).
Pharmacokinetic equivalence, the primary endpoint of the study, was
observed between ANX-530 and Navelbine(R), the reference product, in
patients with advanced cancer potentially sensitive to vinorelbine.
Equivalence was demonstrated by a statistical comparison of both the areas
under the curve (AUC) and maximum plasma concentrations (Cmax). The Company
anticipates safety and full clinical results will be available during the
first quarter of 2008. Results from this study will be submitted for
presentation at an appropriate medical conference.
"We're very pleased with these results, which we believe will provide
sufficient clinical data to support a Section 505(b)(2) New Drug
Application," said Evan M. Levine, chief executive officer of ADVENTRX. "We
have a meeting scheduled with the FDA in December to discuss our commercial
manufacturing plans. After we receive the FDA's written comments, we intend
to provide an update regarding our NDA timeline for ANX-530."
ANX-530 is a novel emulsion formulation of vinorelbine. Vinorelbine,
marketed under the brand name Navelbine(R), also available as generic
vinorelbine, is an anti-cancer agent approved to treat advanced non-small
cell lung cancer as a single agent or in combination with cisplatin.
Worldwide annual sales of Navelbine and generic vinorelbine in 2006 were
approximately $200 million.
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. The FDA has indicated that this single clinical study, should it
demonstrate pharmacokinetic equivalence between ANX-530 and Navelbine,
would provide sufficient clinical data to support a Section 505(b)(2) NDA.
Pharmacokinetic equivalence was determined based on federal regulations
and FDA guidance regarding bioequivalence studies. 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. 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. 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.
About ANX-530 (vinorelbine emulsion)
ANX-530 is a novel emulsion formulation of vinorelbine tartrate, a
generic chemotherapy agent. ANX-530 is designed to reduce the incidence and
severity of vein irritation 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 Section 505(b)(2)
Section 505(b)(2) of the U.S. Food, Drug & Cosmetic Act (FDCA) allows
the Food and Drug Administration (FDA) to approve a follow-on drug on the
basis of data in the scientific literature or conclusions regarding safety
or effectiveness made by the FDA in the approval of other drugs. This
regulatory pathway potentially makes it easier for drug manufacturers to
obtain rapid approval of new forms of drugs based on the FDA's approval of
the original drug. Some examples of products that may be allowed to follow
a 505(b)(2) path to approval are drugs that have a new dosage form,
strength, route of administration, formulation or indication. Upon
approval, a drug may be marketed only for the FDA-approved indications in
the approved dosage forms. Further clinical trials are necessary to gain
approval for the use of the product for any additional indications or
dosage forms. To the extent a Section 505(b)(2) applicant is relying on the
FDA's findings for an already-approved drug, the applicant is required to
certify to the FDA concerning any patents listed for the approved drug in
the FDA's Orange Book publication, which may include a certification that
listed patents are invalid or will not be infringed by the manufacture, use
or sale of the new drug.
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, bioavailability,
excessive toxicity and treatment resistance. More information can be found
on the Company'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; 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.
SOURCE ADVENTRX Pharmaceuticals, Inc.
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Related links:
http://www.adventrx.com
CONTACT:
Ioana C. Hone of ADVENTRX Pharmaceuticals,
+1-858-552-0866
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