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