FDA Clears CoFactor to
Begin Second Stage of Phase II Clinical Trial for Metastatic
SAN DIEGO--(BUSINESS WIRE)--Nov. 2, 2004--ADVENTRX
Pharmaceuticals, Inc. (Amex: ANX) today announced that it has
been granted allowance by the Food and Drug Administration (FDA)
to begin recruiting patients for the second stage of its Phase
II trial using CoFactor(TM) to modulate the effect of
5-fluorouracil (5-FU) for metastatic colorectal cancer. The
Company reported available clinical data to the FDA related to
the 23 initial patients recruited as part of the Simon Two-Stage
trial design. Based on this submission, the FDA granted the
Company authorization to proceed to the second stage of the
study and enroll an additional 25 patients.
The Phase II trial of CoFactor is an open-label single arm study
to evaluate safety, tumor response, time-to-tumor-progression
and overall survival in patients treated with CoFactor and 5-FU.
Eligible patients for this study have surgically incurable,
metastatic colon or rectal adenocarcinoma, and no prior
chemotherapy for metastatic disease.
"We are extremely pleased to receive the go-ahead from the FDA
to advance CoFactor to the second stage of the Phase II clinical
trial," said Cellia Habita, M.D., Ph.D., Vice President of
Clinical and Medical Affairs for ADVENTRX. "At this rate, we
currently anticipate completing total patient enrollment by the
end of 2004 and reporting results in the spring."
The Company currently plans to file in 2004 in the European
Union and in 2005 in the US for clearance to begin randomized
controlled Phase II multicenter metastatic colorectal cancer
trials. In addition, the Company currently intends to file with
the FDA and the European Medicines Agency (EMEA) in the first
quarter of 2005 to begin trials for treatment of patients with
advanced pancreatic cancer in both the US and EU. In October
2004, the FDA and EMEA each granted the Company orphan drug
status for CoFactor for the treatment of pancreatic cancer in
the US and EU, respectively.
CoFactor (5,10-methylenetetrahydrofolate) is a biomodulator
designed for use with 5-FU, a commonly used cancer drug.
CoFactor is the active metabolite of leucovorin that bypasses
the chemical pathway required by leucovorin to deliver the
correct form of folate to cancer cells, allowing 5-FU to work
more effectively. In previous Phase II trials in Europe,
CoFactor was administered to metastatic colorectal cancer
patients 20 minutes before intravenous administration of 5-FU.
In these European trials, CoFactor improved survival and
time-to-tumor-progression while lowering toxicity in metastatic
colorectal cancer patients.
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. More information on ADVENTRX can be
found on 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 United States Food and Drug
Administration and other regulatory agencies. The Company
undertakes no obligation to release publicly any revisions,
which may be made to reflect events or circumstances after the
CONTACT: ADVENTRX PharmaceuticalsAndrea Lynn, 858-552-0866
Kevin Theiss, 212-732-4300
SOURCE: ADVENTRX Pharmaceuticals, Inc.