Results Indicate Bioequivalent Pharmacokinetics With Reduced Risk of
Hypersensitivity Reactions With ANX-514
SAN DIEGO, April 25 /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, today announced positive results from
preclinical pharmacokinetic testing of ANX-514 (docetaxel emulsion) in a
well recognized animal model. The study results indicate bioequivalent
pharmacokinetics between ANX-514 and the FDA-approved version of docetaxel,
marketed under the brand name Taxotere(R). Furthermore, ANX-514,
administered intravenously, did not cause hypersensitivity reactions in
this study, as opposed to acute hypersensivity reactions observed following
intravenous treatment with Taxotere. ANX-514 is a novel emulsion
formulation of docetaxel, an agent for the treatment of breast, non-small
cell lung, prostate and gastric cancers.
"These preclinical results are important and strengthen our belief that
ANX-514 is an appropriate candidate for marketing approval under the
shorter timelines available under Section 505(b)(2)," said Evan M. Levine,
chief executive officer for ADVENTRX. "In addition, these results suggest
that treatment with ANX-514 may eliminate the need for multi-day
premedication with corticosteroids prior to treatment, which is currently
recommended prior to treatment with Taxotere."
In this study, docetaxel concentration in plasma was sequentially
measured over 24 hours following intravenous injections with either ANX-514
or Taxotere. Pharmacokinetic analysis indicated no statistically
significant (p < 0.05) differences in docetaxel maximum concentration
(Cmax) or area under the curve (AUC) between ANX-514 and Taxotere. In
addition, less toxicity was observed following dosing with ANX-514 than
dosing with Taxotere. Taxotere induced an anaphylactoid type reaction
consistent with hypersensitivity reactions, including acute increases in
blood histamine levels and decreased blood pressure. In contrast, no
hypersensitivity reactions, including no elevations in histamine levels and
no changes in blood pressure were observed following dosing with ANX-514.
ADVENTRX is continuing to conduct additional preclinical
pharmacokinetic testing of ANX-514 to compare this product candidate with
the approved version of the product, marketed under the brand name
Taxotere. The Company currently plans to seek guidance from the FDA with
respect to the appropriateness of a Section 505(b)(2) NDA regulatory path
for ANX-514, and pending agreement on clinical protocol design with the
FDA, initiate a marketing-enabling clinical trial of ANX-514 in 2007.
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
designed to eliminate the need for multi-day immunosuppressant
premedication. 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 allergic 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 Taxotere
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 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.
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; 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 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 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.
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 of ADVENTRX
Pharmaceuticals, +1-858-552-0866; or Media, Amy Martini of
WeissComm Partners, +1-212-301-7223, for ADVENTRX
Pharmaceuticals, Inc.
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