SAN DIEGO, Sept. 27 /PRNewswire-FirstCall/ -- ADVENTRX Pharmaceuticals,
Inc. (Amex: ANX), a biopharmaceutical research and development company
focused on commercializing proprietary product candidates for the treatment
of cancer and infectious diseases, announced today that data from
preclinical studies of ANX-514 (docetaxel emulsion) will be presented at
the American Association of Cancer Research (AACR), National Cancer
Institute (NCI) and European Organization and Treatment of Cancer (EORTC)
International Conference "Molecular Targets and Cancer Therapeutics" in San
Francisco, October 22-26, 2007. The abstract entitled "A novel emulsion
formulation of docetaxel eliminates hypersensitivity reactions without
impacting pharmacokinetics or antitumor activity" will be presented on
October 25, 2007 at 12:30p.m. Pacific Standard Time.
ANX-514 is a novel emulsion formulation of docetaxel. Docetaxel is an
anti-cancer agent that is approved to treat breast, non-small cell lung,
prostate, gastric and head and neck cancers, and is marketed under the
brand name Taxotere(R). Annual sales of Taxotere in 2006 were approximately
$2.2 billion.
ADVENTRX recently received confirmation from the U.S. Food and Drug
Administration (FDA) regarding its proposed 505(b)(2) New Drug Application
(NDA) regulatory plan for ANX-514 (docetaxel emulsion). The FDA indicated
that data from a single study of approximately 28 patients that
demonstrates the bioequivalence of ANX-514 and Taxotere is sufficient to
support filing an NDA.
About ANX-514 (docetaxel emulsion)
ANX-514 is a novel nano-emulsion formulation of the chemotherapy drug
docetaxel, a product marketed under the brand name Taxotere. ANX-514 is
formulated without polysorbate 80 or other detergents and is intended to
reduce the severity and/or incidence of hypersensitivity reactions.
Docetaxel is an anti-cancer agent that acts by disrupting the cellular
microtubular network that is essential for cell division. Immunosuppressant
premedication is recommended for docetaxel therapy to reduce the incidence
and severity of hypersensitivity reactions. Docetaxel is approved to treat
breast, non-small cell lung, prostate, gastric and head and neck cancers.
In connection with a Section 505(b)(2) NDA covering ANX-514, ADVENTRX must
certify that all applicable docetaxel patents have expired prior to the
manufacture, use or sale of ANX-514.
About Section 505(b)(2)
Section 505(b)(2) of the U.S. Food, Drug & Cosmetic Act (FDCA) allows
the 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.
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, 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. These risks and
uncertainties include, but are not limited to: the risk that preclinical
results are not indicative of the success of subsequent clinical trials and
that products will not perform as preclinical data suggests or as otherwise
anticipated; the FDA's views on the appropriateness of seeking marketing
approval of ANX-514 under Section 505(b)(2); difficulties or delays in
developing, testing, manufacturing and marketing and obtaining regulatory
approval for ANX-514, including receiving necessary regulatory approvals
for clinical trials of ANX-514, in a timely manner or at all, and the
potential for automatic injunctions regarding FDA approval of ANX-514 and
other challenges by patent holders during the Section 505(b)(2) process;
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;
the potential for regulatory authorities to require additional preclinical
work or other clinical requirements to support regulatory filings; patent
and non-patent exclusivity covering docetaxel; 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, including funding the
continued development of ANX-514; 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, including as 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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