SAN DIEGO, May 4 /PRNewswire-FirstCall/ -- ADVENTRX Pharmaceuticals, Inc.
(Amex: ANX) announced today that it has started dosing patients in a first
line Phase II clinical trial to test CoFactor in metastatic colorectal cancer.
CoFactor, a biomodulator of 5-fluorouracil (5-FU), one of the most widely used
chemotherapeutic agents, will be evaluated in patients not previously treated
or in those who have relapsed from previous 5-FU/leucovorin therapy. CoFactor
qualifies for the FDA's Fast Track Program for rapid drug review for
metastatic colorectal cancer. In addition to the VA San Diego Healthcare
System, the trial is taking place at several other sites in the U.S, including
Mercy General Hospital in Sacramento, California, where the first patients
were dosed.
"We are very pleased to begin testing of CoFactor in the U.S.," commented
Cellia Habita, M.D., Ph.D., Vice President of Clinical and Medical Affairs for
ADVENTRX Pharmaceuticals. "This is the first stage in our expansion of
clinical testing of CoFactor for treatment of a variety of cancers, with an
emphasis on lower toxicities and increased survival compared to current
therapies. Later this quarter, we also intend to file for clearance to begin
first-line metastatic colorectal cancer trials in the UK as part of our
international strategy for regulatory approvals."
CoFactor (5,10-methylenetetrahydrofolate) is a chemotherapy drug designed
for use with 5-FU. CoFactor is a form of folic acid which acts by enhancing
the anti-tumor effects of 5-FU while reducing side effects compared to current
therapies. Unlike leucovorin, the currently used adjunctive agent, which has
to be metabolized in the body to be effective, CoFactor bypasses the
biochemical pathway to deliver the correct form of folate to cancer cells
allowing 5-FU to work more effectively. CoFactor was previously studied in
Phase II trials in Europe which showed a 100 mg dose of CoFactor given 20
minutes before IV administration of the chemotherapy agent 5-FU was able to
improve survival in metastatic colorectal cancer patients and showed very low
toxicity.
"Delivering folate in this form may allow 5-FU to work more efficiently to
abate tumor growth. This appears to be the case from the data from previous
European studies," remarked Tony Reid, M.D., Ph.D., the study's Principal
Investigator of the VA San Diego Healthcare System. "We certainly hope similar
results can be achieved here in the U.S."
According to the American Cancer Society, colorectal cancer is the third
most common cancer both in men and women and is the second leading cause of
cancer death in the U.S.
About ADVENTRX
ADVENTRX Pharmaceuticals Inc. is a biopharmaceutical research and
development company whose business strategy is to commercialize leading edge
medical research through licensing agreements with prominent universities and
research institutions. The Company focuses on cancer and antiviral research to
launch products that either extend the usefulness of current therapies or
replace marginal therapies with new approaches to treatment.
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 United States Food and Drug Administration. The Company undertakes no
obligation to release publicly any revisions, which may be made to reflect
events or circumstances after the date hereof.
Contact:
The Ruth Group
Investors: Stephanie Carrington
646-536-7017
Media: Cynthia Isaac, Ph.D.
646-536-7028
SOURCE ADVENTRX Pharmaceuticals, Inc.
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CONTACT: Investors, Stephanie Carrington of The Ruth Group, +1-646-536-7017; or Media, Cynthia Isaac, Ph.D., +1-646-536-7028, both for ADVENTRX Pharmaceuticals, Inc.
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