SAN DIEGO, Feb. 15, 2011 /PRNewswire/ -- ADVENTRX
Pharmaceuticals, Inc. (NYSE Amex: ANX) today provided an update on
its product candidate, ANX-514, its polysorbate 80-free formulation
of docetaxel. The U.S. Food and Drug Administration (FDA)
determined that ANX-514 could not be approved based on the findings
from the bioequivalence study of ANX-514 (Study 514-01) and that
additional development activities would be required for approval.
ADVENTRX met with the FDA to discuss required activities.
"We are pleased with the outcome of our discussion with FDA, at
which the conceptual design of a single, additional clinical study
that could support approval of ANX-514 was discussed. We
believe the study requested by the Agency is reasonable, and we are
developing a study protocol for submission to the FDA. We
will provide a further update after receiving feedback from FDA on
the protocol," said Brian M. Culley,
Chief Executive Officer of ADVENTRX.
"We have netted over $50 million
from financings during the last 18 months and we intend to use this
capital to continue to develop ANX-514, to pursue acquisition
opportunities, such as our recently-announced agreement to acquire
SynthRx, and to prepare for the commercial launch of Exelbine™,
should it be approved," Mr. Culley continued.
ADVENTRX met with the FDA to discuss ANX-514. Prior to the
meeting, ADVENTRX submitted to the FDA a data package based on
Study 514-01 and published literature. ADVENTRX believes the
data package supports the conclusion that comparable clinical
outcomes can be expected following treatment with either ANX-514 or
Taxotere®, despite Study 514-01 not demonstrating bioequivalence,
its primary endpoint, using an unscaled bioequivalence methodology.
In particular, the data package concludes that unbound
docetaxel concentrations better represent the pharmacokinetics of
docetaxel and are better predictors of clinical effects and
outcomes.
The FDA did not agree that evaluating bioequivalence using
unbound docetaxel concentrations was warranted and determined that
data from Study 514-01 was not adequate to conclude that the short
period of higher exposure to total docetaxel concentrations
observed early in the treatment cycle with ANX-514 do not adversely
affect the safety or efficacy of ANX-514 relative to Taxotere.
About ADVENTRX Pharmaceuticals
ADVENTRX Pharmaceuticals is a specialty pharmaceutical company
focused on acquiring, developing and commercializing proprietary
product candidates principally for the treatment of cancer.
More information can be found on the Company's web site at
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 are based on ADVENTRX's current
expectations and assumptions. Such forward-looking statements
include, but are not limited to, statements regarding the potential
for submission and approval of an ANX-514 NDA by the FDA based on a
single, additional clinical study, the continued development of
ANX-514 by ADVENTRX, including additional clinical and
manufacturing work, and ADVENTRX's ability to fund such activities,
ADVENTRX's belief that the short period of higher exposure to total
docetaxel concentrations observed early in the treatment cycle with
ANX-514 in Study 514-01 does not adversely affect the safety or
efficacy of ANX-514 relative to Taxotere, the regulatory approval
and commercial launch of Exelbine by ADVENTRX, and the potential
for pipeline expansion through acquisition of new product
candidates or technologies, including consummation of ADVENTRX's
acquisition of SynthRx, Inc. Actual events or results may differ
materially from those expressed or implied by the forward-looking
statements in this press release due to a number of risks and
uncertainties, including, without limitation: the potential for the
FDA to require significant further nonclinical studies and/or
clinical testing of ANX-514, including more than one clinical
trial, which generally are more costly and lengthy than
bioequivalence trials; the risk that additional nonclinical and/or
clinical activities required by the FDA prior to the filing or the
approval of a New Drug Application (NDA) for ANX-514 may result in
ADVENTRX's determination that the commercial potential of ANX-514
does not justify the required investment and ADVENTRX's
discontinuation of the program; the risk that, if ADVENTRX
determines to continue development of ANX-514, ADVENTRX may need to
raise additional capital to fund the additional development
activities required by the FDA and that the necessity of such
activities may negatively impact ADVENTRX's ability to raise
additional capital for development of and/or partner ANX-514;
difficulties or delays in manufacturing ANX-514 for additional
clinical or bioequivalence studies; difficulties or delays in
obtaining regulatory approval for ANX-514, even if ADVENTRX
conducts additional nonclinical and/or clinical activities required
by the FDA, including the potential for automatic injunctions
regarding FDA approval of ANX-514 and other challenges by patent
holders during the Section 505(b)(2) process; difficulties or
delays in manufacturing and marketing ANX-514, including validating
commercial manufacturing processes and manufacturers, as well as
suppliers; ADVENTRX's reliance on the performance of third parties
to assist in the conduct of its nonclinical, clinical and
bioequivalence studies, regulatory submissions, CMC activities,
commercial launch activities and other important aspects of the
Exelbine and ANX-514 development programs, and that such third
parties may fail to perform as expected; ADVENTRX's current
dependence on the success of Exelbine and ANX-514 and the
possibility that ADVENTRX does not receive regulatory approval of
Exelbine or ANX-514 on a timely basis, or at all; the risk that
ADVENTRX may not be able to successfully commercialize Exelbine or
ANX-514 if it receives regulatory approval for those product
candidates; the risk that ADVENTRX will pursue development
activities at levels on timelines, or will incur unexpected
expenses, that shorten the period through which its operating funds
will sustain it; the potential that Exelbine and/or ANX-514 will be
subject to a future collaboration or other strategic transaction;
the risk that ADVENTRX's acquisition of SynthRx, Inc. may not be
consummated; the potential for ADVENTRX to enter into a merger or
other business combination in connection with a new product
candidate acquisition resulting in a successor entity that focuses
its resources on developing products and product candidates other
than ADVENTRX's existing product candidates, including Exelbine and
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
www.sec.gov.
You are cautioned not to place undue reliance on 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 hereof, except as may be required by
law.
SOURCE ADVENTRX Pharmaceuticals, Inc.