SAN DIEGO, Sept. 10 /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 it has received
confirmation from the U.S. Food and Drug Administration (FDA) regarding its
proposed 505(b)(2) New Drug Application (NDA) regulatory path for ANX-514
(docetaxel emulsion). The FDA has indicated that data from a single study
of approximately 28 patients that demonstrates the bioequivalence of
ANX-514 and docetaxel is sufficient to support filing an NDA. 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.
"This guidance from the FDA is significant as conducting a single
marketing-enabling trial provides us a clear and direct clinical path and
substantially shortens the timelines for clinical development and
submitting an NDA for ANX-514," said Evan M. Levine, chief executive
officer of ADVENTRX. "Pending appropriate clearances, we look forward to
starting the proposed bioequivalence trial later this year."
The Company currently plans to submit an investigational new drug (IND)
application in the fourth quarter of 2007. The proposed clinical trial will
compare the blood levels of docetaxel following a single dose of ANX-514 or
Taxotere in patients with advanced cancers. In addition, the Company plans
to analyze the safety of ANX-514.
ANX-514 Preclinical Results
Preclinical results have demonstrated equivalent pharmacokinetics
between ANX-514 (docetaxel emulsion) and the FDA-approved version of
docetaxel, marketed under the brand name Taxotere. ANX-514 administered
intravenously did not cause hypersensitivity reactions, as opposed to acute
hypersensitivity reactions that were observed following intravenous
treatment with Taxotere. Antitumor activity of the two products in animal
models was similar.
About ANX-514 (docetaxel emulsion)
ANX-514 is a novel nano-emulsion formulation of the chemotherapy drug
docetaxel, which is 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.
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. In connection with a Section 505
(b)(2) NDA covering ANX-514, ADVENTRX must certify that all applicable
Taxotere patents have expired prior to the manufacture, use or sale of
ANX-514.
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
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; 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 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
http://www.prnewswire.com/comp/920134.html /
CONTACT:
Investors, Ioana C. Hone, +1-858-552-0866,
for ADVENTRX Pharmaceuticals, Inc.
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