SAN DIEGO, Oct. 26, 2011 /PRNewswire/ -- ADVENTRX
Pharmaceuticals, Inc. (NYSE Amex: ANX) announced today that it met
with the U.S. Food and Drug Administration (FDA) to discuss a
single clinical study to support approval of ANX-514 (docetaxel for
injectable emulsion), a detergent-free reformulation of Taxotere
(docetaxel).
ADVENTRX proposed a non-inferiority study (Study 514-02) with a
primary objective of comparing fluid retention following treatment
with ANX-514, administered without corticosteroid premedication,
and Taxotere®, administered with corticosteroid premedication,
which would enroll approximately 400 patients. The FDA agreed
that the proposed study would generate sufficient clinical data to
support approval of ANX-514 without requiring corticosteroid
premedication.
Eric K. Rowinsky, M.D., principal
clinical advisor to ADVENTRX, said, "Eliminating the high-dose
corticosteroid premedication required with Taxotere would represent
a significant benefit to cancer patients. Corticosteroids
expose cancer patients to otherwise unnecessary and costly
complications, such as hyperglycemia, immunosuppression and
insomnia. ANX-514 has the potential to improve the
tolerability and safety of docetaxel treatment while eliminating
toxicities caused by the polysorbate 80 detergent and complications
associated with the Taxotere premedication regimen."
Brian M. Culley, Chief Executive
Officer of ADVENTRX, said, "We are very pleased to have reached
agreement with the FDA on a reasonable path to approval for
ANX-514. Our focus is on initiating Study 514-02 as soon as
possible and submitting an NDA in 2014."
Mr. Culley continued: "The high-dose steroids required with
Taxotere are problematic for all cancer patients, and in particular
those who have diabetes or a predisposition to hyperglycemia, who
we estimate constitute one-third of the patients who receive
Taxotere."
About Study 514-02
Study 514-02 will be a randomized, open-label, multicenter,
non-inferiority study comparing ANX-514, administered without
corticosteroid premedication, and Taxotere, administered with
corticosteroid premedication, in the treatment of non-small cell
lung cancer after failure of prior platinum-based therapy.
Approximately 400 patients will be enrolled and treated until
evidence of progressive disease, unacceptable toxicity, withdrawal
of consent, or other withdrawal criteria are met. The primary
objective will be to compare the incidence of fluid retention
between study arms. The secondary objectives will be to
compare ANX-514 and Taxotere in terms of overall safety profile,
objective response rate, duration of response, progression-free
survival and overall survival.
About ADVENTRX Pharmaceuticals
ADVENTRX Pharmaceuticals is a specialty pharmaceutical company
focused on developing proprietary product candidates. The
Company's current lead product candidates are ANX-188, a novel,
purified, rheologic and antithrombotic compound initially being
developed as a first-in-class treatment for pediatric patients with
sickle cell disease in acute crisis, and ANX-514, a detergent-free
formulation of the blockbuster drug Taxotere®, which recently went
off-patent. The Company is seeking a partner or outside
investor for its Exelbine program. 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 design
for, and timing and feasibility of, Study 514-02, the timing of
submission of an NDA for ANX-514, the prospects for ultimate
approval of an NDA for ANX-514 without clinical studies in addition
to Study 514-02, the prospects for elimination of the high-dose
corticosteroid premedication required with Taxotere and the
potential for ANX-514 to improve the tolerability and safety of
docetaxel treatment. Actual events or results may differ materially
from those expressed or implied by the forward-looking statements
in this press release due to a number of risks and uncertainties,
including, without limitation: the risk that ADVENTRX is unable to
raise sufficient capital to fund development of its product
candidates, including ANX-514; the risk that the primary endpoint
in Study 514-02 is not met; the risk that, to demonstrate
non-inferiority in Study 514-02, the rate of fluid retention in the
ANX-514 arm must be lower than the rate in the Taxotere arm;
uncertainty regarding the relative contribution of polysorbate 80
versus docetaxel or other factors on the incidence and severity of
fluid retention and other adverse events; uncertainty regarding the
impact of removing corticosteroid premedication from the ANX-514
arm on the incidence and severity of adverse events; the risk that,
even if ANX-514 meets the primary endpoint in Study 514-02, it may
not demonstrate comparable overall safety to Taxotere and,
accordingly, may not be sufficient to support an NDA or eliminate
corticosteroid premedication without additional clinical studies;
the risk that the results of an additional bioequivalence study, if
required by FDA, will cause the FDA to require additional
nonclinical and/or clinical studies in addition to Study 514-02
prior to the submission or approval of an NDA for ANX-514; the risk
that the FDA does not grant market approval of ANX-514 on a timely
basis, or at all; the potential for difficulties or delays in
completing manufacturing process development activities and
manufacturing material for Study 514-02 and any other clinical
studies; ADVENTRX's reliance on third parties to assist in the
conduct of important aspects of its product candidates' development
programs, including manufacture of clinical trial material, conduct
of Study 514-02 and other clinical trials and regulatory
submissions related to product approval, and that such third
parties may fail to perform as expected; 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.