SAN DIEGO, Oct. 2, 2012 /PRNewswire/ -- ADVENTRX
Pharmaceuticals, Inc. (NYSE MKT: ANX) today announced that it has
engaged Theradex® Systems, Inc., a contract research organization
with 30 years of experience, to manage the Company's upcoming phase
3 study of ANX-188 (purified poloxamer 188) in sickle cell
disease.
"The engagement of Theradex is one of the final steps before
initiating our phase 3 study of ANX-188 in patients with sickle
cell disease experiencing vaso-occlusive crisis," said Brian M. Culley, Chief Executive Officer of
ADVENTRX. "We selected Theradex based on its extensive experience
in the management and oversight of clinical trials, which includes
studies in patients with sickle cell disease and a 29-year
collaboration with the National Cancer Institute in the United
States. We are confident in Theradex's ability to assist us in
executing a high-quality, efficient phase 3 study of ANX-188."
About ADVENTRX Pharmaceuticals
ADVENTRX Pharmaceuticals is a biopharmaceutical company
developing proprietary product candidates to treat various diseases
and conditions. The Company's lead product candidate, ANX-188, has
potential to reduce ischemic tissue injury and end-organ damage by
restoring microvascular function which is compromised in a wide
range of serious and life-threatening diseases and
conditions. The Company initially is developing ANX-188 as a
treatment for complications arising from sickle cell disease. More
information can be found on the Company's web site at
www.adventrx.com.
About Theradex Systems, Inc.
Theradex is an international contract research organization
providing complete professional services for the clinical research
and development of pharmaceutical compounds, medical devices and
diagnostic tests in the areas of oncology and life-threatening
diseases. Theradex® conducts studies which lead to
marketing approval of significant medical advances; and has built a
reputation on assuring the scientific objectivity and meticulous
quality control that fulfills all regulatory requirements. For 29
years, Theradex has held the Clinical Trials Monitoring Service
Contract for the National Cancer Institute in the United States. Theradex's clients include
international biotech and pharmaceutical companies.
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
development plans for ANX-188, including the nature and timing of
future clinical studies, and Theradex's potential impact on such
studies. Among the factors that could cause or contribute to
material differences between ADVENTRX's actual results and those
indicated from the forward-looking statements are risks and
uncertainties inherent in ADVENTRX's business, including, but not
limited to: the potential for delays in the commencement or
completion of planned clinical studies including as a result of
difficulties or delays in completing manufacturing process
development activities and manufacturing clinical trial material or
difficulties or delays in obtaining regulatory agreement on
clinical study design or meeting applicable regulatory requirements
for clinical trial material; the risk of suspension or termination
of a clinical study including due to lack of adequate funding; the
risk that planned clinical studies are not successful and, even if
they are successful, that the FDA could determine they are not
sufficient to support an NDA for the product candidate; the
potential for ADVENTRX to delay, reduce or discontinue current
and/or planned development activities, including clinical studies,
partner its product candidates at inopportune times or pursue less
expensive but higher-risk development paths if it is unable to
raise sufficient additional capital as needed; ADVENTRX's ability
to obtain additional funding on a timely basis or on acceptable
terms, or at all; the risk that the FDA does not grant marketing
approval of ADVENTRX's product candidates, including ANX-188, on a
timely basis, or at all; ADVENTRX's reliance on third parties to
assist in the conduct of important aspects of its product
candidates' development programs, including the manufacture of
clinical trial material, the conduct of clinical studies and
preparation of regulatory submissions related to product approval,
and that such third parties may fail to perform as expected; 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.
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SOURCE ADVENTRX Pharmaceuticals, Inc.