SAN DIEGO, Feb. 15,
2011 /PRNewswire via COMTEX/ --
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(TM), 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(R), 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.