SAN DIEGO, Dec. 19, 2012
/PRNewswire/ -- ADVENTRX Pharmaceuticals, Inc. (NYSE MKT: ANX)
today announced that ANX-188 drug product for use in the phase 3
clinical study of ANX-188 (purified poloxamer 188), manufactured
using the Company's proprietary purification process, has passed
quality control (QC) release specifications at Patheon, the
Company's contract manufacturer, and currently is in the quality
assurance (QA) release process. The study has been approved by
multiple institutional review boards (IRB) and initiation of the
study is expected in approximately six weeks.
Santosh Vetticaden, Chief Medical Officer, said: "Our clinical
operations team has achieved numerous milestones over the past
several months that will allow us to initiate the EPIC study as
early as next month. We have multiple IRB approvals, multiple
clinical trial agreements with study sites, and we have assembled a
top-flight data safety monitoring board. Last week, we held our
first investigators' meeting, and I was impressed by the level of
enthusiasm for the study that was expressed by leaders in the
sickle cell disease medical community."
Brian M. Culley, Chief Executive
Officer, said: "We were expecting to initiate the study prior
to year-end, but unforeseen delays at one of our vendors will push
trial initiation into early next year. However, this upfront
delay means we will have more sites open at study initiation and
the delay will not extend the overall study timeline. Our
focus now is on releasing drug product and shipping it to our
contract facility on the East Coast, where it will be labeled and
distributed to clinical sites, all of which we expect to take place
over the next few weeks. In parallel, we continue to qualify and
open additional study sites."
Mr. Culley continued: "Looking ahead, we are preparing to
initiate a thorough QT study of ANX-188 and announce our plans to
develop ANX-188 in an indication outside of sickle cell disease,
which will further increase the commercial potential of, and
partnering interest in, this important investigational drug."
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 planned phase 3 clinical study of ANX-188,
including the timing of its initiation and completion and the
number of study sites open at initiation, and the impact of a
forthcoming announcement of development of ANX-188 for an
indication outside of sickle cell disease on its commercial and
partnering prospects. 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 further delays in the
commencement or completion of planned clinical studies, including
the phase 3 study of ANX-188 in sickle cell disease, 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, negotiating agreements with
potential clinical study sites, enrolling study subjects or being
subject to a "clinical hold"; the risk that the rate of enrollment
in the planned phase 3 study of ANX-188 is slower than was
anticipated prior to the study's initiation; the impact of missing
or imputed data on the treatment effect observed in the prior phase
3 study of ANX-188 in sickle cell disease; 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; 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
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.