SAN DIEGO, Feb. 28, 2013 /PRNewswire/ -- ADVENTRX
Pharmaceuticals, Inc. (NYSE MKT: ANX) today announced its plans to
develop ANX-188 in complications of arterial disease, initially as
an adjunct to thrombolytics in acute limb ischemia (ALI), a
complication of peripheral arterial disease. Peripheral
arterial disease affects an estimated 8 to 12 million people in
the United States.
Arterial disease resulting from atherosclerotic and
thromboembolic processes is a common circulatory problem in which
plaque-obstructed arteries reduce the flow of blood to
tissues. Peripheral arterial disease refers to disease
affecting arteries outside the brain and heart and often refers to
blockage of arteries in the lower extremities. Ischemic
cerebrovascular infarction, or stroke, results from blockage of
arteries to the brain, while myocardial infarction, or heart
attack, results from blockage of arteries to the heart.
Thrombolytic agents, such as tPA (tissue plasminogen activator),
commonly referred to as "clot busting" drugs, are used to treat
acute complications of peripheral arterial disease, heart attack
and stroke.
R. Martin Emanuele, Senior Vice
President, Development, said: "Data from experimental models
demonstrate the potential for ANX-188, when used alone or in
combination with thrombolytics, to improve outcomes for patients
with thrombotic arterial disease, whether manifesting as acute limb
ischemia, stroke or some other variant. Studies in animals
and humans suggest that ANX-188 can shorten time-to-thrombolysis,
improve blood flow, delay re-occlusion and reduce reperfusion
injury, each of which may improve the effectiveness of existing
thrombolytic agents."
Santosh Vetticaden, Chief Medical Officer, said: "We plan to
evaluate the potential of ANX-188 in arterial disease initially by
evaluating it in acute limb ischemia. Near-term goals include
seeking orphan drug designation for ANX-188 in ALI, meeting with
FDA to discuss our development plan in ALI and, assuming FDA agrees
with the plan, initiating a phase 2, clinical proof-of-concept
study in late 2013 or early 2014. Currently, we estimate that
third-party costs to conduct this study will be approximately
$2 million and that it will take
approximately 15 to 18 months to enroll. Ultimately, we plan
to leverage the data in ALI to find a partner to develop ANX-188 in
larger indications within arterial disease, such as
stroke."
Conference Call Information
The Company will hold a
conference call tomorrow, Friday, March 1,
2013, at 8:30 a.m. (ET),
5:30 a.m. (PT) to discuss its
development plans in acute limb ischemia. Interested parties
may access the conference call by dialing (800) 860-2442 from the
U.S. and (412) 858-4600 from outside the U.S. and should request
the ADVENTRX Pharmaceuticals Update Call. The webcast will be
available live via the Internet by accessing the Events &
Presentations page of Investors section of ADVENTRX's website at
http://www.adventrx.com/investors/events/. Replays of the webcast
will be available on the Company's website for 30 days and a phone
replay will be available through March 6,
2013 by dialing (877) 344-7529 from the U.S. and (412)
317-0088 from outside the U.S. and entering conference reference
number 10025903.
About ADVENTRX Pharmaceuticals
ADVENTRX
Pharmaceuticals is a publicly traded biopharmaceutical company
headquartered in San Diego,
CA. The Company is leveraging the MAST (Molecular Adhesion
and Sealant Technology) platform, derived from over two decades of
clinical, nonclinical and manufacturing experience with purified
and non-purified poloxamers, to develop ANX-188, its lead product
candidate, for serious or life-threatening diseases with
significant unmet needs. ANX-188 is a cytoprotective,
hemorheologic, anti-inflammatory and anti-thrombotic agent that has
potential utility in diseases or conditions characterized by
microcirculatory insufficiency (endothelial dysfunction and/or
impaired blood flow).
The Company is recruiting subjects in EPIC, a pivotal phase 3
study of ANX-188 in sickle cell disease. The Company plans to
initiate a phase 2 clinical study of ANX-188 in acute limb
ischemia, a complication of peripheral arterial disease, in late
2013 or early 2014. 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 ANX-188 to demonstrate
clinical benefit in patients suffering from complications of
arterial disease, including ALI, ADVENTRX's plans to seek orphan
drug designation for ANX-188 in ALI, and ADVENTRX's near- and
long-term development plans for ANX-188 in arterial disease and the
timing of activities related to those plans. Among the
factors that could cause or contribute to material differences
between ADVENTRX's actual results and expectations indicated by the
forward-looking statements are risks and uncertainties that
include, but are not limited to: the potential for delays in the
commencement or completion of clinical studies, including as a
result of difficulties in obtaining regulatory agency agreement on
clinical development plans or clinical study design, opening trial
sites, enrolling study subjects, manufacturing clinical trial
material, completing manufacturing process development activities,
and being subject to a "clinical hold"; the risk of suspension or
termination of a clinical study, including due to lack of adequate
funding or patient safety concerns; the potential for institutional
review boards or the FDA or other regulatory agencies to require
additional nonclinical or clinical studies prior to initiation of
planned phase 2 clinical studies of ANX-188 in any particular
indication in which ADVENTRX determines to develop ANX-188,
including ALI, which likely would increase the total time and cost
of development in the indication; the risk that clinical studies of
ANX-188 are not successfully executed and/or do not successfully
demonstrate its safety or efficacy; the risk that, even if clinical
studies are successful, the FDA determines they are not sufficient
to support a new drug application; the risk that even if clinical
studies of ANX-188 in one indication are successful, clinical
studies in another indication may not be successful; ADVENTRX's
reliance on contract research organizations (CROs), contract
manufacturing organizations (CMOs), and other third parties to
assist in the conduct of important aspects of development of
ANX-188, including clinical studies, and regulatory activities for
ANX-188 and that such third parties may fail to perform as
expected; ADVENTRX's ability to obtain additional funding on a
timely basis or on acceptable terms, or at all; the potential for
ADVENTRX to delay, reduce or discontinue current and/or planned
development activities, including clinical studies, partner ANX-188
at inopportune times or pursue less expensive but higher-risk
development paths if it is unable to raise sufficient additional
capital as needed; the risk that acceptable partnering
opportunities for ANX-188 may not be available in particular
jurisdictions or indications and, consequently, ADVENTRX may not be
able to pursue development of ANX-188 in certain jurisdictions and
indications; the risk that the FDA does not grant marketing
approval of ANX-188, on a timely basis, or at all; the risk that
ADVENTRX is not able to adequately protect its intellectual
property rights relating to the MAST platform and ANX-188 and
prevent competitors from duplicating or developing equivalent
versions of its product candidates, including 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.
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SOURCE ADVENTRX Pharmaceuticals, Inc.