ADVENTRX Announces CoFactor(R) Phase 2b Clinical Trial Overall Survival Results
June 16 2008 - 6:00AM
PR Newswire (US)
SAN DIEGO, June 16 /PRNewswire-FirstCall/ -- ADVENTRX
Pharmaceuticals, Inc. (AMEX:ANX) today provided an update with
regard to overall survival from its Phase 2b clinical trial of
CoFactor for the treatment of first-line metastatic colorectal
cancer. Overall survival results in this study have been revised
upwards slightly, with the CoFactor/5-FU (5-fluorouracil) arm
demonstrating a 14 day improvement in overall survival compared to
the leucovorin/5-FU arm. "In the Phase 2b study, CoFactor was dosed
at 60mg/m2 by infusion to provide as unbiased a comparison as
possible to leucovorin, which is administered at 200 mg/m2 by
infusion over about 2 hours in this setting," stated Evan M.
Levine, Chief Executive Officer and President of ADVENTRX. "Even
while administering CoFactor over hours instead of the more optimal
2 to 3 minute bolus administration, and at a significantly lower
dose of the folate, we were able to demonstrate a numerical
advantage with respect to overall survival and progression-free
survival with CoFactor plus 5-FU in this study, which is
encouraging." Consistent with its previous guidance, the Company
anticipates announcing available interim data from its discontinued
Phase 3 trial of CoFactor for the treatment of first line
metastatic colorectal cancer later this month. Furthermore, the
Company is on track to announce its decision about how to best move
forward with its CoFactor program later this month. About the
CoFactor Phase 2b Study The Phase 2b clinical trial was an
international, open-label, randomized, controlled, multicenter
study designed to evaluate the safety and efficacy of treatment
with CoFactor/5-FU compared to leucovorin/5-FU utilizing an
infusional administration in patients with first line metastatic
colorectal cancer. Three hundred patients were randomized to
receive CoFactor/5-FU or leucovorin/5- FU. The CoFactor/5-FU arm
demonstrated comparable overall safety to the leucovorin/5-FU arm.
However, the CoFactor/5-FU arm did not demonstrate statistically
significant improved safety in the trial's primary endpoint, a
reduction in the proportion of patients reporting at least one
hematological or gastrointestinal adverse event of grade 3 or
greater. 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-FU (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
results of pending clinical trials for CoFactor; unexpected adverse
side effects or inadequate therapeutic efficacy of CoFactor; 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; the risk that ADVENTRX will be unable to
raise sufficient capital to fund the projects necessary to meet its
anticipated or stated goals and milestones; the potential to
attract a strategic partner 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; 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. 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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