ADVENTRX Reports Phase II CoFactor Trial Update
October 06 2005 - 9:30AM
Business Wire
ADVENTRX Pharmaceuticals, Inc. (AMEX:ANX) today announced that
patient follow up is nearly complete and data are being analyzed in
its US-based Phase II COFU trial. COFU is a multi-center trial to
evaluate the safety and efficacy of weekly treatment with
CoFactor(TM) and 5-fluorouracil (5-FU) in patients with metastatic
colorectal cancer. CoFactor is a biomodulator designed to enhance
the effects and reduce the associated toxicity of the widely used
cancer drug 5-FU. The Company also announced that two abstracts
containing these COFU clinical data were submitted for
consideration in the 2006 Gastrointestinal Cancers Symposium
program. The symposium is sponsored in part by the American Society
of Clinical Oncology (ASCO) and will be held in San Francisco,
January 26-28, 2006. ADVENTRX completed patient enrollment in this
Phase II clinical trial in January 2005 and met the primary
endpoint for response rate and the secondary endpoint for safety.
The Company announced preliminary investigator-reported tumor
response and safety results in May and June 2005. The serial
radiographical (CT) scans, which comprise the objective response
data for all patients in the study, are being evaluated
independently by a third party masked with respect to the
investigator interpretations. These results will be included in the
study findings, which the Company currently plans to report in the
first quarter of 2006. "We continue to be encouraged by our
CoFactor clinical program progress, including the positive
preliminary results of our COFU trial demonstrating CoFactor's
clinical benefit with reduced toxicity," said Evan M. Levine,
president and CEO of ADVENTRX Pharmaceuticals. "In addition to our
plan to report independently verified data from our COFU trial in
the first quarter of 2006, we continue to ramp up our other
clinical trials with CoFactor. We are currently conducting a
multi-national Phase IIb trial using CoFactor plus 5-FU as a first
line treatment of metastatic colorectal cancer, and we have also
received clearance from the US Food and Drug Administration (FDA)
to initiate a pivotal Phase III trial in the same indication. We
are actively recruiting clinical sites in preparation for this
Phase III trial and expect to begin treating patients in the first
quarter of 2006." About CoFactor CoFactor (ANX-510) is a
folate-based biomodulator drug developed to enhance the activity
and reduce associated toxicity of the widely used cancer
chemotherapeutic 5-FU. In comparison to leucovorin, CoFactor
creates more stable binding of the active form of 5-FU, FdUMP, to
the target enzyme, thymidylate synthase (TS). CoFactor bypasses the
chemical pathway required by leucovorin to deliver the active form
of folate, allowing 5-FU to work more effectively. This improves
5-FU performance and lowers toxicity. More information on CoFactor
can be found at
http://www.adventrx.com/products/antic_cofactor.htm. About ADVENTRX
ADVENTRX Pharmaceuticals is a biopharmaceutical research and
development company focused on introducing new technologies for
anticancer and antiviral treatments that improve the performance
and safety of existing drugs, by addressing significant problems
such as drug metabolism, toxicity, bioavailability and resistance.
More information can be found on the Company's Web site at
www.adventrx.com. Forward Looking Statement This press release
contains forward-looking statements within the meaning of the "safe
harbor" provisions of the Private Securities Litigation Reform Act
of 1995. Such statements are made based on management's current
expectations and beliefs. Actual results may vary from those
currently anticipated based upon a number of factors, including
uncertainties inherent in the drug development process, the timing
and success of clinical trials, the validity of research results,
and the receipt of necessary approvals from the FDA and other
regulatory agencies. For a discussion of such risks and
uncertainties, which could cause actual results to differ from
those contained in the forward-looking statements, see "Risk
Factors" in the Company's last quarterly report on Form 10-Q, as
well as other reports that the Company files from time to time with
the Securities and Exchange Commission. All forward-looking
statements are qualified in their entirety by this cautionary
statement. The Company undertakes no obligation to release publicly
any revisions, which may be made to reflect events or circumstances
after the date hereof.
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