ADVENTRX to Present ANX-514 Preclinical Data at 2007 AACR-NCI-EORTC International Conference
September 27 2007 - 6:00AM
PR Newswire (US)
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. 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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