ADVENTRX Cleared to Initiate Vinorelbine Emulsion Bioequivalence Study
December 26 2006 - 6:00AM
PR Newswire (US)
SAN DIEGO, Dec. 26 /PRNewswire-FirstCall/ -- ADVENTRX
Pharmaceuticals, Inc. (AMEX:ANX) today announced that its
Investigational New Drug (IND) application for the clinical
development of its proprietary cancer drug ANX-530 (vinorelbine
emulsion) has been accepted by the United States Food and Drug
Administration (FDA). In taking this action, the FDA acknowledged
the suitability of the Company's clinical study protocol to
establish the bioequivalence of ANX-530, and Navelbine(R)
(vinorelbine tartrate). Navelbine is an anti-cancer agent approved
for use in non-small cell lung cancer. Patient recruitment for this
study is expected to begin in January 2007. The FDA has affirmed
this 28-patient clinical study to be sufficient as a
marketing-enabling trial. "We believe ANX-530 will show
bioequivalence to the marketed form of vinorelbine," said Evan M.
Levine, chief executive officer of ADVENTRX. "Further, we
anticipate filing a new drug application (NDA) by the end of 2007,
potentially making ANX-530 the Company's first commercial oncology
product." This bioequivalence study builds on promising preclinical
results which demonstrated that the pharmacokinetics of ANX-530
were unchanged as compared to the approved form of vinorelbine.
Furthermore, no difference in anti-tumor activity was observed
between the two formulations. In addition, ANX-530 demonstrated
markedly reduced vein irritation, edema, and erythema at the site
of injection. The study is a multicenter, open-label, randomized
crossover comparison of ANX-530 and the approved reference product
Navelbine(R) (vinorelbine tartrate) in 28 patients with advanced
solid tumors. The primary objective of the study is to evaluate the
pharmacokinetic profile of the two drugs in serum. About Section
505(b)(2) The Company plans to file an NDA for ANX-530 based on the
provisions of section 505(b)(2) of the U.S. Food, Drug &
Cosmetic Act. Section 505(b)(2) allows the FDA to approve a drug on
the basis of data in the scientific literature or data previously
cited by the FDA as the basis for the approval of related drugs.
This procedure makes it easier and potentially faster for drug
developers to obtain approval of new formulations of drugs based,
in part, on proprietary data of the developer of the original drug.
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 IV-delivery of the drug. Vinorelbine 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 low development risk
pharmaceuticals for cancer and infectious disease that enhance the
efficacy and/or safety of existing therapies. 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,
uncertainties, assumptions and other factors that, if they do not
materialize or 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. Such forward-looking
statements are made based on management's current expectations and
beliefs and should not be regarded as a statement or representation
by ADVENTRX that any of its plans, including its anticipated
milestones, will be achieved on time or at all. The potential risks
and uncertainties that could cause actual results to differ
materially include, but are not limited to: the risk that ADVENTRX
will be unable to raise sufficient capital to fund the projects
necessary to meet its anticipated or stated goals and milestones;
the potential to attract a strategic partner and the terms of any
related transaction; the ability to timely enroll subjects in
ADVENTRX's current and anticipated clinical trials; the results of
pending clinical trials for ANX-530 or ADVENTRX's other product
candidates, including the lack of bioequivalence of ANX-530 and
Navelbine; the potential for ANX-530 and ADVENTRX's other product
candidates to receive regulatory approval for one or more
indications on a timely basis or at all, and the uncertain process
of seeking regulatory approval; other difficulties or delays in
developing, testing, manufacturing and marketing of and obtaining
regulatory approval for ANX-530 or ADVENTRX's other product
candidates; the market potential for vinca alkaloids and other
target markets, and ADVENTRX's ability to compete in those markets;
unexpected adverse side effects or inadequate therapeutic efficacy
of ANX-530 or ADVENTRX's other products that could delay or prevent
regulatory approval or commercialization, or that could result in
recalls or product liability claims; the risk that preclinical and
clinical results are not indicative of the success of subsequent
clinical trials and that products will not perform as preclinical
and clinical data suggests or as otherwise anticipated; the
potential for regulatory authorities to require additional
preclinical work or other clinical requirements to support
regulatory filings; the scope and validity of patent protection for
ANX-530 and ADVENTRX's other product candidates; 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. All forward-looking
statements are qualified in their entirety by this cautionary
statement and ADVENTRX assumes no obligation to revise or update
any forward-looking statement, including as set forth in this press
release, to reflect events or circumstances arising after the date
on which it was made. DATASOURCE: ADVENTRX Pharmaceuticals CONTACT:
Ioana C. Hone of ADVENTRX Pharmaceuticals, +1-858-552-0866 Web
site: http://www.adventrx.com/ Company News On-Call:
http://www.prnewswire.com/comp/920134.html
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