SAN DIEGO, Feb. 26, 2013 /PRNewswire/ -- ADVENTRX
Pharmaceuticals, Inc. (NYSE MKT: ANX) today reviewed the platform
of data and know-how that supports development of ANX-188 in
multiple indications, including those outside of sickle cell
disease. This platform has been derived from over 100
pharmacology studies, more than 15 clinical studies in multiple
indications in which over 2,500 subjects have been exposed to both
purified and non-purified poloxamer 188, and over two decades of
experience manufacturing and purifying poloxamers.
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Brian M. Culley, Chief Executive
Officer, said: "Since acquiring SynthRx, we have come to
appreciate the extent of the data supporting the development of
ANX-188 not just in sickle cell disease, but in any indication
where improving microcirculatory insufficiency is central to
improving clinical outcomes. The breadth and depth of these
data can be characterized as a 'platform,' which we refer to as the
Molecular Adhesion and Sealant Technology, or MAST, platform.
We plan to leverage the knowledge and know-how that is the MAST
platform to advance ANX-188 in multiple indications, and will
announce development plans outside of sickle cell disease later
this quarter."
R. Martin Emanuele, Ph.D, Senior
Vice President, Development, said: "In addition to initiating EPIC,
our pivotal phase 3 study in sickle cell disease, we have analyzed
the impressive body of data that supports development of ANX-188 in
a broader range of diseases and conditions. ANX-188 adheres
specifically to hydrophobic surfaces characteristic of damaged
cells in the circulation, effectively 'sealing' the damaged area
and, as a result, minimizing or preventing other hydrophobic
adhesive interactions and providing time for natural repair
mechanisms to restore normal functioning. Meanwhile, because
pathological hydrophobic domains are not characteristically present
in a healthy circulation, ANX-188 has no clinically significant
activity in healthy circulatory tissue. While this mechanism
specifically targets hydrophobic domains, these domains can be
widespread in sick or injured patients. This 'broadly
targeted' activity gives ANX-188 potential to address multiple
pathophysiological processes in complex indications relative to
drugs based on specific receptor/ligand interactions."
Santosh Vetticaden, Chief Medical Officer, said:
"Proof-of-concept in experimental models has been demonstrated with
the active ingredient in ANX-188 in a wide range of diseases, such
as arterial disease, stroke, shock and heart failure. As we
advance ANX-188 into new indications, we intend to leverage already
completed IND-enabling toxicology studies, phase 1 safety studies
and the other activities that consume so much time and money in
drug development. With clinical trial material already
in-hand, we expect to move ANX-188 directly into phase 2 studies
and generate clinical proof-of-concept data in new indications in
relatively short time frames with relatively modest
investment."
About the MAST (Molecular Adhesion and Sealant Technology)
Platform
The MAST platform reflects the repository of both proprietary
(to ADVENTRX) and non-proprietary poloxamer-related data, know-how
and other information that has been developed over the course of
several decades by numerous sponsors, most recently by
ADVENTRX. It reflects the accumulated knowledge of over 100
pharmacology studies, more than 15 clinical studies in multiple
indications in which over 2,500 subjects have been exposed to both
purified and non-purified poloxamer 188, and over two decades of
experience manufacturing and purifying poloxamers.
About ADVENTRX Pharmaceuticals
ADVENTRX Pharmaceuticals is a biopharmaceutical company
developing novel therapies for serious or life-threatening diseases
with significant unmet needs. ADVENTRX is leveraging the MAST
platform to develop ANX-188, its lead product candidate, for
conditions characterized by microcirculatory insufficiency
(endothelial dysfunction and/or impaired blood flow). The
Company initially is developing ANX-188 in sickle cell disease and
is recruiting subjects in EPIC, a randomized, double-blind,
placebo-controlled phase 3 study in patients with sickle cell
disease. 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 the MAST platform to facilitate development of ANX-188 in one
or more indications, including by reducing time and expense of its
development in any particular indication, the potential for the
pharmacodynamics properties of ANX-188 to translate into clinical
benefit in one or more indications, and the timing of development
in ANX-188 in indications outside of sickle cell disease.
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 and
clinical studies prior to initiation of planned phase 2 clinical
studies in any particular indication in which ADVENTRX determines
to develop ANX-188, 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 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.
SOURCE ADVENTRX Pharmaceuticals, Inc.