ADVENTRX Reports Patient Enrollment Progress With CoFactor Phase IIb Trial
October 10 2005 - 9:30AM
Business Wire
ADVENTRX Pharmaceuticals, Inc. (AMEX:ANX) today announced that it
has completed approximately 25% of the planned enrollment in its
European Union (EU)-based CoFactor(TM) Phase IIb clinical trial for
the treatment of metastatic colorectal cancer. The Company began
dosing patients in this trial in May 2005. CoFactor is ADVENTRX's
biomodulator designed to enhance the effects and reduce associated
toxicity of the widely used cancer drug, 5-fluorouracil (5-FU). The
Phase IIb clinical trial is a multi-center, open label, randomized
study to evaluate the safety and efficacy of CoFactor and 5-FU
versus leucovorin and 5-FU in first-line treatment for metastatic
colorectal cancer. Approximately 300 patients in this study will be
randomized to receive either CoFactor plus 5-FU, or leucovorin plus
5-FU. To date 21 clinical sites have been opened for patient
enrollment in the United Kingdom, India, Serbia, Poland and
Romania. The Company plans to open an additional nine clinical
sites for patient enrollment by the end of October 2005. "We are
delighted by the rate of patient enrollment in this trial, which
has so far exceeded our expectations," said Evan M. Levine,
president and CEO of ADVENTRX Pharmaceuticals. "We believe this
trial will further establish CoFactor's favorable safety and
efficacy profile in a direct comparison to leucovorin. As we
continue to move our CoFactor clinical programs forward, we remain
confident in our ability to achieve our goal of commercialization."
ADVENTRX is also completing its US-based Phase II CoFactor trial
(COFU) in metastatic colorectal cancer and expects to report
follow-up study data, including a third-party assessment of
efficacy data, from this trial in the first quarter of 2006.
Additionally, the Company is currently recruiting clinical sites
for a US-based pivotal Phase III trial in the same indication, and
plans to begin dosing 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 US Food and Drug
Administration (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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