SAN DIEGO, Oct. 25, 2012 /PRNewswire/ -- ADVENTRX
Pharmaceuticals, Inc. (NYSE MKT: ANX) today provided details
regarding the phase 3 clinical study of ANX-188 (purified poloxamer
188) in sickle cell disease that it plans to initiate this
quarter. The Company will host a conference call today at
4:30 p.m. Eastern Time, 1:30 p.m. Pacific Time (access information below)
to discuss the study.
The study will be a randomized, double-blind, two-arm,
placebo-controlled study conducted at approximately 40 sites
primarily in the U.S. The primary objective will be to
demonstrate that ANX-188 reduces the duration of vaso-occlusive
crisis in patients with sickle cell disease. The duration of
vaso-occlusive crisis will be measured from the time a subject is
randomized to the time at which the subject receives the last dose
of parenteral opioid analgesic for the treatment of vaso-occlusive
crisis prior to hospital discharge. A total of 388 subjects
ages 8 to 17 who have sickle cell disease and are experiencing
acute pain typical of vaso-occlusive crisis will be enrolled.
Using a two-sided alpha of 0.05, the study has approximately 90%
power to detect a 16-hour difference between treatment arms.
Secondary endpoints will compare re-hospitalization rate (for
vaso-occlusive crisis) within 14 days of initial discharge from the
hospital and the occurrence of acute chest syndrome within 120
hours of randomization.
"Following an iterative and collaborative dialog with the FDA,
and with valuable input from physicians who treat sickle cell
patients, we are pleased to have finalized our phase 3 study
protocol. Consistent with our plans when we acquired ANX-188,
the study will focus on children. In a post-hoc analysis of a
prior phase 3 study, ANX-188 demonstrated a statistically
significant reduction in the duration of crisis in a subgroup of
younger patients. With the improvements we have incorporated
into the upcoming study, we believe ANX-188 can improve on the
treatment effect that previously was observed and potentially
provide a new treatment option for this debilitating and
life-threatening condition, for which there are no approved
therapies," said Brian M. Culley,
Chief Executive Officer of ADVENTRX.
Conference Call Information
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, Inc. Call. The webcast will be
available live via the Internet by accessing the Investors section
of ADVENTRX's website at http://ir.adventrx.com. Replays
of the webcast will be available on the Company's website for 30
days and a phone replay will be available through November 1, 2012 by dialing (877) 344-7529 from
the U.S. and (412) 317-0088 from outside the U.S. and entering
conference reference number 10019681.
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.
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 details of the planned phase 3 clinical
study of ANX-188, including its timing and the number and ages of
subjects to be enrolled, the potential treatment effect of ANX-188
in the planned phase 3 study and the potential clinical care and
public health benefits of ANX-188, if approved. 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 in completing
manufacturing process development activities, manufacturing
clinical trial material, meeting applicable regulatory requirements
for clinical trial material, meeting applicable requirements of
institutional review boards overseeing clinical study sites, or
being subject to a "clinical hold"; the impact of missing or
imputed data on the treatment effect observed in the prior phase 3
study; the risk of suspension or termination of a clinical study,
including due to lack of adequate funding or a "clinical hold";
ADVENTRX's reliance on contract research organizations (CROs) and
other third parties to assist in the conduct of important aspects
of its clinical studies, and that such third parties may fail to
perform as expected; the risk that planned clinical studies 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; 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
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.