SAN DIEGO, Feb. 11, 2013 /PRNewswire/ -- ADVENTRX
Pharmaceuticals, Inc. (NYSE MKT: ANX) today announced that it has
initiated dosing in a thorough QT/QTc study (TQT study) of
ANX-188.
Brian M. Culley, Chief Executive
Officer, said: "Consistent with our guidance from October 2011 and our commitment to FDA, we have
initiated this study before the end of the first quarter. We
were pleased with the discussion we had with the Agency on the
study protocol and our agreement on the supra-therapeutic
dose."
Santosh Vetticaden, Chief Medical Officer, said: "The FDA
requires an assessment of cardiac repolarization for most new drugs
having systemic bioavailability. This study will assess
whether or not ANX-188 has an effect on QT prolongation. The study
should complete dosing in the first quarter, and we expect to
announce results in the second quarter of 2013."
The objective of the TQT study is to evaluate the effect of
therapeutic and supra-therapeutic doses of ANX-188 on cardiac
ventricular repolarization, specifically the QT-interval, in
healthy volunteers. The study is a single center,
four-period, four-way cross-over, placebo- and positive-controlled,
double-blind, randomized trial. Sixty subjects will be
enrolled. Each subject will receive each of four treatments
(placebo, active control, ANX-188 therapeutic dose, ANX-188
supra-therapeutic dose) during each of the four treatment
periods.
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 is recruiting subjects in EPIC, a
randomized, double-blind, placebo-controlled phase 3 study of
ANX-188 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 timing of
completion and announcement of results of the TQT study. 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 inherent in
ADVENTRX's business, including, but not limited to: the potential
for delays in the commencement or completion of clinical studies,
including as a result of difficulties with opening trial sites or
enrolling study subjects or 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;
ADVENTRX's reliance on contract research organizations (CROs) to
conduct its clinical studies and on other third parties to assist
with important aspects of its development and regulatory activities
for ANX-188 and the potential for such third parties to fail to
perform as expected or required; the risk that clinical studies,
including EPIC and the TQT study, are not successfully executed
and/or do not successfully demonstrate the safety or efficacy of
the investigational drug; 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 an investigational drug in one indication are
successful, clinical studies of the same investigational drug in
another indication may not be successful; 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 its product candidates at
inopportune times or pursue less expensive but higher-risk and/or
lower-return development paths if it is unable to raise sufficient
additional capital as needed; 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; 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.