SAN DIEGO, Aug. 30, 2011 /PRNewswire/ -- ADVENTRX
Pharmaceuticals, Inc. (NYSE Amex: ANX) today provided an update on
its planned meetings with the U.S. Food and Drug Administration
(FDA) regarding its three late-stage programs:
Exelbine (vinorelbine injectable emulsion)
- Type A meeting with FDA has been requested. This meeting
is to discuss the complete response letter regarding the Company's
New Drug Application (NDA) for Exelbine. The Company will
present information that it believes demonstrates the authenticity
of study drugs used in the pivotal study.
ANX-514 (docetaxel for injectable emulsion)
- Type B clinical meeting with FDA has been requested. This
meeting is to discuss the pivotal safety study that FDA recommended
at a meeting earlier this year. The Company is proposing a
randomized, open-label study designed to descriptively evaluate the
safety of ANX-514 without corticosteroid premedication and
Taxotere® with corticosteroid premedication in non-small cell lung
cancer.
- Type B CMC meeting with FDA has been requested. This
meeting is to discuss the manufacture of ANX-514 for clinical trial
material in connection with the planned pivotal safety study and
for commercial product.
ANX-188 (purified poloxomer 188)
- Type B clinical meeting with FDA is planned for the fourth
quarter of 2011. This meeting will be to confirm prior
agreements with FDA, reach agreement on key aspects of the planned
phase 3 pediatric study in sickle cell crisis and discuss the
overall development plan.
- Type B CMC meeting with FDA is planned for the first quarter of
2012. This meeting will be to discuss the manufacture of
ANX-188 for clinical trial material in connection with the planned
phase 3 study and for commercial product.
"Frequent contact with FDA is critical to the success of our
clinical programs, and the number of our upcoming meetings with FDA
demonstrates our commitment in this regard. Following these
meetings, we intend to provide updates with respect to key events
for each of our programs, including timelines for study initiation,
study completion and NDA submission," said Brian M. Culley, Chief Executive Officer of
ADVENTRX. "In the meantime, we continue to prepare to
initiate the ANX-188 and ANX-514 pivotal studies next year.
Our cash and equivalents, which were $40.7 million at July
31, allow us to make substantial progress on these
programs," 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
reformulation of the blockbuster drug Taxotere, which recently went
off-patent. The Company is evaluating its Exelbine program
following the complete response letter it received from the FDA.
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
expectations regarding its meetings with the FDA, including the
timing and outcome of each of those meetings, ADVENTRX's belief
that information it will present to the FDA demonstrates the
authenticity of the drugs used in its bioequivalence study of
Exelbine, and the nature and timing of the ANX-188 and ANX-514
development programs, including anticipated timing for initiation
of pivotal clinical studies. 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
meetings with the FDA do not take place on the timelines
anticipated by ADVENTRX and, as a result, decisions regarding its
Exelbine program and initiation of its anticipated clinical studies
of ANX-188 and ANX-514 are delayed; the potential for the FDA to
impose further requirements, including clinical studies, before or
after approval of Exelbine; the potential for ADVENTRX to
discontinue its investment in the Exelbine program and instead
pursue partnership opportunities for Exelbine; the risk that the
FDA does not grant market approval of Exelbine, whether submitted
by ADVENTRX or a future partner, on a timely basis, or at all;
difficulties or delays in reaching agreement with the FDA on the
clinical development of ANX-188 and ANX-514; the potential for the
FDA to require significant additional clinical and/or nonclinical
studies of ADVENTRX's lead product candidates, in addition to its
planned clinical trials of ANX-188 and ANX-514, and that ADVENTRX
consequently determines to discontinue one or more of its
development programs; 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, 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; the risk
that ADVENTRX will pursue acquisition and/or development activities
at levels on timelines, or will incur unexpected expenses, that
shorten the period through which its operating funds will sustain
it; 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.