ADVENTRX Announces Preliminary Response Rate Data From Discontinued Phase 3 Trial of CoFactor(R)
July 01 2008 - 7:00AM
PR Newswire (US)
SAN DIEGO, July 1 /PRNewswire-FirstCall/ -- ADVENTRX
Pharmaceuticals, Inc. (AMEX:ANX) today announced preliminary
response rate results from its discontinued Phase 3 clinical trial
of ANX-510, or CoFactor, the Company's folate-based biomodulator of
5-FU (5 fluorouracil), for the treatment of first-line metastatic
colorectal cancer. The primary endpoint of the study was
progression-free survival, which is expected to mature and be
reported by the Company along with safety data later this year.
Data from the 85 patients treated in the study demonstrated a 39.0%
objective response rate in the CoFactor/5-FU/Avastin(R)
experimental arm compared to a 31.8% objective response rate in the
leucovorin/5-FU/Avastin control arm. The data also demonstrated a
48.8% stable disease rate and 4.8% progressive disease rate in the
CoFactor experimental arm compared to a 38.6% stable disease rate
and 15.9% progressive disease rate in the leucovorin control arm.
Objective response rate was measured according to RECIST criteria
and was based on the number of complete responses and partial
responses observed in this study based on investigators'
assessments. In the study, both CoFactor and 5-FU were administered
as an i.v. bolus. Currently, there are 10 patients receiving
treatment in this study, with 6 patients on the CoFactor
experimental arm and 4 patients on the leucovorin control arm.
Based on the data available at this time, the Company intends to
evaluate potential options for the continued development of
CoFactor. As the Company makes progress it anticipates providing
updates regarding its development plans for CoFactor. "As we
evaluate further safety and efficacy data from our Phase 3 trial
and the results of our pharmacokinetic bridging study, we expect to
assess our options for continued development of CoFactor, including
potentially reinitiating discussions with regulatory authorities,"
stated Evan M. Levine, Chief Executive Officer and President of
ADVENTRX. "Given our encouraging progress with ANX-530 and ANX-514,
our resources are focused primarily on advancing our later-stage
product candidates, which includes submitting an NDA for ANX-530
and completing our registrational bioequivalence clinical study for
ANX-514," added Mr. Levine. About the Discontinued Phase 3 Clinical
Study The Phase 3 clinical trial was a randomized, controlled,
multicenter study designed to evaluate the safety and efficacy of
CoFactor/5-FU/Avastin and leucovorin/5-FU/Avastin in patients with
first-line metastatic colorectal cancer. Eighty-nine patients were
randomized to either the leucovorin control arm or the CoFactor
experimental arm, with a bolus regimen of 5-FU (the Roswell Park
regimen) and Avastin; eighty-five patients were treated. The
primary endpoint in this study was an improvement in
progression-free survival. Secondary endpoints included response
rate, overall survival and incidence and severity of adverse
events. About ANX-510, or CoFactor CoFactor is a folate-based
biomodulator designed to replace leucovorin as the preferred method
to enhance the activity and reduce associated toxicity of the
widely used cancer chemotherapeutic agent 5-fluorouracil. Compared
to leucovorin, CoFactor creates more stable binding between the
active form of 5-FU and the target enzyme, thymidylate synthase.
CoFactor bypasses the metabolic pathway required by leucovorin to
deliver the active form of folate, potentially allowing 5-FU to
work more effectively. About ADVENTRX Pharmaceuticals ADVENTRX
Pharmaceuticals is a biopharmaceutical company focused on
in-licensing, developing and commercializing proprietary product
candidates primarily for the treatment of cancer and infectious
disease. The Company seeks to improve the performance and
commercial potential of existing treatments by addressing problems
associated with these treatment regimens. More information can be
found on ADVENTRX's web site at http://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 involve risks and
assumptions that, if they materialize or do not prove to be
accurate, could cause ADVENTRX's results to differ materially from
historical results or those expressed or implied by such
forward-looking statements. These risks and uncertainties include,
but are not limited to: the risk that ADVENTRX does not continue
the development of CoFactor, including based on the pharmacokinetic
results from ADVENTRX's pharmacokinetic bridging study,
progression-free and overall survival, as well as final safety,
results from ADVENTRX's discontinued Phase 3 study or revisions to
previously announced CoFactor results; the Company's inability to
identify and secure approval from applicable regulatory authorities
for an appropriate, cost-effective development path for CoFactor;
the risk that ADVENTRX will be unable to raise sufficient capital
to fund the continued development of CoFactor or the Company's
other product candidates; the potential to attract a strategic
partner for the Company's product candidates and the terms of any
related transaction; the potential for ADVENTRX's product
candidates to receive regulatory approval for one or more
indications on a timely basis or at all, and the uncertain process
of seeking regulatory approval; unexpected or a greater than
expected number of expected adverse side effects or inadequate
therapeutic efficacy of CoFactor, regardless of administration
method, or ADVENTRX's other product candidates; the risk that
preclinical and clinical results are not indicative of the success
of subsequent clinical trials and that products will not perform as
preclinical and clinical data suggests or as otherwise anticipated;
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
http://www.sec.gov/. You are cautioned not to place undue reliance
on these forward-looking statements, which speak only as of the
date when made. ADVENTRX does not intend to update any
forward-looking statement set forth in this press release to
reflect events or circumstances arising after the date on which it
was made. Investor Contact: ADVENTRX Pharmaceuticals Ioana C. Hone
858-552-0866 DATASOURCE: ADVENTRX Pharmaceuticals, Inc. CONTACT:
Investors, Ioana C. Hone of ADVENTRX Pharmaceuticals,
+1-858-552-0866 Web site: http://www.adventrx.com/
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