ADVENTRX Meets Primary Endpoint in ANX-530 Marketing-Enabling Clinical Study
November 16 2007 - 6:00AM
PR Newswire (US)
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. DATASOURCE: ADVENTRX Pharmaceuticals, Inc. CONTACT: Ioana
C. Hone of ADVENTRX Pharmaceuticals, +1-858-552-0866 Web site:
http://www.adventrx.com/
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