SAN DIEGO, Dec. 1, 2011 /PRNewswire/ -- ADVENTRX
Pharmaceuticals, Inc. (NYSE Amex: ANX) announced today that it met
with the U.S. Food and Drug Administration (FDA) to review
development plans for ANX-188 (purified poloxamer 188), the
Company's first-in-class treatment for sickle cell patients
experiencing vaso-occlusive crisis.
ADVENTRX and the FDA discussed a variety of topics related to
the overall development of ANX-188, as well as the design of a
phase 3 study for the treatment of sickle cell patients
experiencing vaso-occlusive crisis. While an understanding
regarding certain matters was reached, additional interaction over
the next several weeks and months is needed to finalize ANX-188
development plans. During that time the Company will continue
to make progress on the manufacture of clinical trial material so
that a phase 3 study can be initiated in 2012.
Brian M. Culley, Chief Executive
Officer of ADVENTRX, said, "As part of our commitment to a strong
relationship with FDA, we have met with the Agency four times in
recent months to discuss development plans for our product
candidates. In particular, with a complex condition such as sickle
cell crisis, it is crucial to have clarity around all aspects of
our development plans for ANX-188. We appreciate FDA's continued
involvement and look forward to further dialogue with the Agency,
which will allow us to reach agreement on a path to approval for
ANX-188 for the benefit of sickle cell patients."
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 novel, detergent-free
formulation of the chemotherapy drug docetaxel. 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 development
plans for ANX-188 and their timing, including a phase 3 clinical
trial and the manufacture of clinical material for that study, and
involvement of the FDA in ADVENTRX's development of ANX-188.
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: delays associated with the development of ANX-188,
including reaching agreement with the FDA with respect to the
overall development plan for ANX-188, as well as the design of the
planned phase 3 study for the treatment of sickle cell crisis, and
manufacturing clinical trial material for the planned phase 3
study; the potential for the FDA to require additional nonclinical
or clinical work prior to initiating the planned phase 3 study
and/or in addition to that study; the potential for the FDA's
requirements for approval of ANX-188 to change after ADVENTRX
reaches agreement with the FDA with respect to its overall
development plan for ANX-188; difficulties and delays in
identifying and qualifying contract manufacturers and contract
research organizations to assist in the development of ANX-188,
including with regard to the planned phase 3 study; the potential
for difficulties or delays in completing manufacturing process
development activities and manufacturing material for and/or in
completing enrollment of the planned phase 3 clinical trials and
any other clinical studies; ADVENTRX's reliance on third parties to
assist in the conduct of important aspects of its ANX-188 program,
including the manufacture of clinical trial material, the conduct
of clinical trials and regulatory submissions related to product
approval, and that such third parties may fail to perform as
expected; the potential for the time and cost required to develop
ANX-188 to be greater than ADVENTRX's current expectations; the
potential that ADVENTRX may require substantial additional funding
to develop and commercialize ANX-188, and the risk that ADVENTRX
may not be able to raise sufficient capital when needed, or at all;
the risk that clinical study results do not support the safety and
efficacy or the commercial viability of ANX-188; the risk that the
neither the FDA nor any other regulatory agency approves a product
based on ANX-188; 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.