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.
SOURCE ADVENTRX Pharmaceuticals, Inc.
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Related links:
http://www.adventrx.com
CONTACT:
investors, Ioana C. Hone of ADVENTRX
Pharmaceuticals, +1-858-552-0866
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