ADVENTRX Completes Patient Enrollment in ANX-514 Bioequivalence Study
05 Febbraio 2009 - 12:00PM
PR Newswire (US)
SAN DIEGO, Feb. 5 /PRNewswire-FirstCall/ -- ADVENTRX
Pharmaceuticals, Inc. (NYSE Alternext US: ANX), announced today
that it has completed patient enrollment in its bioequivalence
study of ANX-514 (docetaxel emulsion for injection). The Company is
on track to announce results from this study in the second quarter
of 2009. ANX-514 is a reformulation of the blockbuster
chemotherapeutic agent, Taxotere(R), an anti-cancer agent that is
approved to treat breast, non-small cell lung, prostate, head and
neck & gastric cancers. In 2007, the aggregate worldwide market
for Taxotere was in excess of $3 billion. The study is a
multi-center, open-label, randomized two-period crossover
comparison of ANX-514 and Taxotere, with a primary endpoint of
pharmacokinetic equivalence of ANX-514 and Taxotere and a goal of
28 evaluable patients. The safety of a single dose of ANX-514 is
being evaluated as a secondary endpoint. The U.S. Food and Drug
Administration has indicated that this single study, should it
demonstrate bioequivalence between ANX-514 and Taxotere, would
provide sufficient human data to support the submission of an NDA.
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 ADVENTRX
Pharmaceuticals ADVENTRX Pharmaceuticals is a biopharmaceutical
company focused on in-licensing, developing and commercializing
proprietary product candidates primarily for the treatment of
cancer. The Company seeks to improve the performance and commercial
potential of existing treatments by addressing problems associated
with these treatment regimens. In December 2008, the Company
announced that it is exploring a range of strategic options,
including the sale or disposition of one or more of its product
candidate programs, a strategic business merger and other
transactions that maximize the value of the Company's assets. More
information can be found on ADVENTRX's web site at
http://www.adventrx.com/. Forward Looking Statements 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 and assumptions that, if they
materialize or do not 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 ADVENTRX will be unable to consummate a strategic or
partnering transaction or raise sufficient capital to fund the
projects necessary to meet its goals, including funding the
continued development and commercialization of ANX-530 or ANX-514;
the risk that the Company's recent cost-cutting measures, as well
as any future workforce reductions and/or reductions/delays in
spending, will negatively impact the Company's development and
commercialization plans, including its ability to achieve on time
its previously stated goals; the risk that the departure of the
Company's former Chief Executive Officer and President and
Executive Vice President and Chief Financial Officer and/or
ADVENTRX's leadership by a committee of executive officers will
negatively impact ADVENTRX's ability to execute its business plan
or to maintain effective disclosure controls and procedures or
internal control over financial reporting; the risk that the
bioequivalence study of ANX-514 does not demonstrate
pharmacokinetic equivalence or bioequivalence; difficulties or
delays in manufacturing, obtaining regulatory approval for and
marketing ANX-514, including validating commercial manufacturers
and suppliers and the potential for automatic injunctions regarding
FDA approval of ANX-514; the potential for regulatory authorities
to require additional preclinical work or other clinical
requirements to support regulatory filings, including prior to the
submission or the approval of an NDA for ANX-514; the risk that the
performance of third parties on whom ADVENTRX relies to conduct its
studies or evaluate the data, including clinical investigators,
expert data monitoring committees, contract laboratories and
contract research organizations, may be substandard, or they may
fail to perform as expected; the risk that ADVENTRX's stockholders
will not approve a strategic or capital-raising transaction
recommended by ADVENTRX's Board of Directors; 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 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: investors, ADVENTRX Pharmaceuticals, Ioana C. Hone,
+1-858-552-0866 Web Site: http://www.adventrx.com/
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