ADVENTRX Provides Update on Cofactor(R) Program
November 02 2007 - 8:00AM
PR Newswire (US)
SAN DIEGO, Nov. 2 /PRNewswire-FirstCall/ -- ADVENTRX
Pharmaceuticals, Inc. (AMEX:ANX), a biopharmaceutical research and
development company focused on commercializing proprietary product
candidates for the treatment of cancer and infectious diseases,
today announced that it will discontinue enrolling patients in its
Phase 3 clinical trial of CoFactor for the first-line treatment of
metastatic colorectal cancer. This decision follows advice ADVENTRX
received from the Data Safety Monitoring Board (DSMB), and
comprehensive analysis of the recently completed Phase 2b clinical
trial of CoFactor for the treatment of metastatic colorectal
cancer. While the DSMB did not identify safety concerns with
CoFactor, it recommended closure of the Phase 3 study, citing a
slow accrual rate due, in part, to current and projected treatment
preferences for colorectal cancer. Further analysis of the Phase 2b
study, in which 5-FU was administered by infusion, has uncovered no
significant differences between the study arms with regard to
either efficacy or safety. Overall survival data from the Phase 2b
study and data from the Phase 3 study are anticipated in the second
quarter of 2008. ADVENTRX will continue its on-going Phase 2
clinical trial of CoFactor for the treatment of advanced breast
cancer, in which 5-FU is administered as a bolus, and anticipates
completing patient enrollment around the end of the year. Results
from this trial are expected in the second quarter of 2008. "We
continue to believe that CoFactor improves 5-FU-based chemotherapy
and that, in the right indications and dosing regimens, CoFactor
remains a viable product candidate. At this time, however, we feel
that a partner for CoFactor would be better equipped to advance
late stage development in first-line colorectal cancer, which
represents the largest market opportunity but also the most costly
and competitive clinical testing environment," commented Evan
Levine, chief executive officer of ADVENTRX. "We are continuing our
Phase 2 study in advanced breast cancer and will assess our ability
to develop CoFactor in this and other indications. We would like to
take the opportunity to thank the patients and their families, as
well as the clinical investigators and their staff, who
participated in and supported our Phase 3 study of CoFactor." "We
remain committed to maximizing shareholder value. We are excited
about several upcoming events, including results from our
marketing-enabling study of ANX-530, as well as initiating a
clinical study of ANX-514 before the end of this year," added Mr.
Levine. About ANX-510, or CoFactor CoFactor is a folate-based
biomodulator drug 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-flluorouracil). Compared to leucovorin, CoFactor creates more
stable binding of the active form of 5-FU to the target enzyme,
thymidylate synthase (TS). CoFactor bypasses the metabolic pathway
required by leucovorin to deliver the active form of folate,
potentially allowing 5-FU to work more effectively. CoFactor is in
a Phase 2 clinical trial for the treatment of advanced breast
cancer. In October 2007, ADVENTRX announced the results from its
Phase 2b clinical trial of CoFactor for the treatment of metastatic
colorectal cancer. 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. In addition, no statistically significant differences
between the arms were observed across overall safety and efficacy
variables. About ADVENTRX Pharmaceuticals ADVENTRX Pharmaceuticals
is a biopharmaceutical research and development company focused on
commercializing proprietary product candidates for the treatment of
cancer and infectious diseases. The Company seeks to improve the
performance and safety of existing treatments by addressing
significant problems, such as drug metabolism and bioavailability,
excessive toxicity and treatment resistance. 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 will be unable to
partner its product candidates and the terms of any related
transaction; the ability to timely enroll subjects in ADVENTRX's
current and anticipated clinical trials; the results of pending
clinical trials; 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, including receiving necessary regulatory approvals for
clinical trials of ANX-514, in a timely manner or at all; the
potential for automatic injunctions under the Section 505(b)(2)
regulatory process and other challenges by patent holders during
that process; other difficulties or delays in developing, testing,
manufacturing and marketing of and obtaining regulatory approval
for ADVENTRX's product candidates; the market potential for
ADVENTRX's product candidates and ADVENTRX's and any future
partners' ability to compete in those markets; unexpected adverse
side effects or inadequate therapeutic efficacy of ADVENTRX's
product candidates that could delay or prevent regulatory approval
or commercialization, or that could result in recalls or product
liability claims; the FDA's views on the appropriateness of seeking
marketing approval of ANX-530 and ANX-514 under Section 505(b)(2);
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; 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: Ioana C. Hone of ADVENTRX Pharmaceuticals, Inc.,
+1-858-552-0866 Web site: http://www.adventrx.com/
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