SAN DIEGO, Sept. 30, 2011 /PRNewswire/ -- ADVENTRX
Pharmaceuticals, Inc. (NYSE Amex: ANX) announced today that it held
a Type A meeting with the U.S. Food and Drug Administration (FDA)
to discuss the complete response letter (CRL) it received in August
from the FDA regarding the Company's New Drug Application (NDA) for
Exelbine™ (vinorelbine injectable emulsion) for the treatment of
non-small cell lung cancer. During the meeting, ADVENTRX
discussed with FDA staff all of the items outlined in the CRL,
including responses previously submitted by the Company to the FDA
during the NDA review and information the Company believes
demonstrates the authenticity of the study drugs used in the
pivotal bioequivalence study of Exelbine (Study 530-01).
As previously announced, the CRL stated that the authenticity of
the study drugs used in Study 530-01 could not be verified.
During the meeting, FDA staff indicated that the clinical
sites, which were selected in 2006 by a third-party contract
research organization, failed to randomly select and retain reserve
samples of the test article (Exelbine) and reference standard
(Navelbine®) and this deficiency could not be overcome by
alternative methods of verifying authenticity and reiterated that
the bioequivalence study would need to be repeated.
Additionally, FDA staff commented that no clinical deficiencies
were noted with Study 530-01 and that there were no comments
regarding the Company's conclusion that Exelbine and Navelbine are
bioequivalent based on Study 530-01 data.
"Although we are pleased with the Agency's assessment of the
clinical data, we are disappointed it could not exercise discretion
in our case to consider other methods of verifying the authenticity
of the study drugs," stated Brian M.
Culley, Chief Executive Officer of ADVENTRX. "The Agency's
assessment of the clinical data gives us confidence that a repeat
study would be successful and that Exelbine can be approved.
However, although the third-party costs to conduct an
additional bioequivalence study and to launch Exelbine are
relatively modest, we believe our stockholders are best served by
focusing our capital on ANX-188 and ANX-514, which reflect larger
market opportunities, and we intend to seek a partner or outside
investor for the Exelbine program."
"Our cash and equivalents of $40.7
million at July 31, plus cost
savings from discontinuing the Exelbine program, will provide us
the capital to advance both our ANX-188 and ANX-514 programs into
their respective pivotal clinical studies next year.
Additionally, we have taken and will continue to take
measures to ensure that our contractors have the qualifications and
experience needed to bring new therapies successfully through
pivotal studies and make them available to patients," Mr. Culley
added.
About ADVENTRX Pharmaceuticals
ADVENTRX Pharmaceuticals is a specialty pharmaceutical company
focused on developing proprietary product candidates. The
Company's current lead product candidates are ANX-188, a novel,
purified, rheologic and antithrombotic compound initially being
developed as a first-in-class treatment for pediatric patients with
sickle cell disease in acute crisis, and ANX-514, a detergent-free
formulation of the blockbuster drug Taxotere®, which recently went
off-patent. The Company is seeking a partner or outside
investor for its Exelbine program. 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 ADVENTRX's
beliefs that a single, additional bioequivalence study could
support FDA approval of Exelbine and that the third-party costs of
such a repeat study and to launch Exelbine are relatively minor,
the extent to which ADVENTRX's cash position and cash savings from
discontinuing its Exelbine program will enable it to advance its
other development programs, and the qualifications, experience and
performance of third parties that ADVENTRX engages to assist in the
development of product candidates, including ANX-188 and ANX-514.
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 risk that any future
bioequivalence study of Exelbine and Navelbine fails to demonstrate
the same clinical results as Study 530-01 or that, even if any such
study does demonstrate substantially similar results, the FDA does
not agree that it demonstrates Exelbine is bioequivalent to
Navelbine; the risk that, in addition to an additional
bioequivalence study, the FDA will impose other requirements,
including further clinical studies, before or after approval of an
Exelbine NDA; the potential that the costs of a repeat study and to
launch Exelbine are significantly greater than ADVENTRX currently
believes; the risk that the FDA does not grant market approval of
Exelbine on a timely basis, or at all; the risk that ADVENTRX is
not able to partner or obtain outside investment for its Exelbine
program on satisfactory terms or on a timely basis or at all; the
potential for difficulties or delays in reaching agreement with the
FDA on the clinical development of ANX-188 and/or ANX-514; the
potential for the FDA to require significant additional clinical
and/or nonclinical studies of ANX-188 and/or ANX-514, in addition
to ADVENTRX's planned pivotal studies for those product candidates,
and that ADVENTRX consequently determines to discontinue one or
more of those programs; 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 risk that investor reaction to
discontinuation of the Exelbine program will negatively impact
ADVENTRX's ability to raise additional capital to fund development
of ANX-188 and ANX-514; difficulties or delays in manufacturing
material for clinical studies; ADVENTRX's reliance on third parties
to assist in the conduct of important aspects of its product
candidates' development programs, including the conduct of clinical
trials, and that such third parties may fail to perform as
expected; the potential for ADVENTRX to raise additional capital to
acquire new technologies, product candidates or products and/or to
fund development and/or commercialization activities for current
and/or future product candidates; 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.