SAN DIEGO, Sept. 25 /PRNewswire-FirstCall/ -- ADVENTRX Pharmaceuticals, Inc. announced today that it has completed patient enrollment in a Phase IIb clinical trial. The trial is designed to compare the safety and efficacy of 5-fluorouracil (5-FU) plus CoFactor(R) to 5-FU plus leucovorin in first line treatment of metastatic colorectal cancer.
“We are pleased that we have completed enrollment in this 300 patient Phase IIb trial, which began in the second quarter of 2005, and we currently expect to announce results in the second half of 2007, as originally planned,” said James A. Merritt, M.D., president and chief medical officer of ADVENTRX. “This trial is significant for us in that it will compare the safety and efficacy of CoFactor/5-FU with leucovorin/5-FU in an infusional setting, a common method of administration of 5-FU for treatment of metastatic colorectal cancer in Europe.”
“We believe the Phase IIb clinical study will reveal important information regarding the direct delivery of the active form of folate through the use of CoFactor,” commented Evan M. Levine, ADVENTRX’s chief executive officer. “We continue to be enthusiastic about CoFactor’s potential for enhancing the efficacy and safety of 5-FU chemotherapy in metastatic colorectal and other cancers, such as breast.”
CoFactor is also being tested in a Phase III pivotal trial in the US in combination with 5-FU and Avastin(R) (bevacizumab).
About the Phase IIb clinical trial:
The CoFactor Phase IIb clinical trial is designed to compare the safety and efficacy of CoFactor plus 5-FU to leucovorin plus 5-FU in first line treatment of patients with metastatic colorectal carcinoma. Three hundred patients were randomized to receive CoFactor plus 5-FU or leucovorin plus 5- FU. The primary endpoint is reduction of grade 3 or greater toxicity (as defined by the NCI Common Terminology Criteria for Adverse Events (version 3)) in the
CoFactor/5-FU arm over the leucovorin/5-FU arm. Secondary endpoints are response rate, time to progression, and quality of life. The clinical trial is being conducted at 30 sites in Europe and India and patient dosing began in the second quarter of 2005. James Cassidy, M.D., MBChB, MSc, FRCP, Professor of Oncology and Head of the Department of Cancer Research in the U.K. Department of Medical Oncology at the University of Glasgow in Glasgow, Scotland, is the study chair.
About CoFactor
CoFactor (ANX-510) is a folate-based biomodulator drug designed to replace leucovorin to enhance the activity and reduce associated toxicity of the widely used cancer chemotherapy 5-fluorouracil (5-FU). In comparison to leucovorin, CoFactor creates more stable binding of the active form of 5-FU 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.
About ADVENTRX
ADVENTRX Pharmaceuticals is a biopharmaceutical research and development company focused on commercializing low development risk pharmaceuticals for cancer and infectious disease that enhance the efficacy and/or safety of existing therapies. More information can be found on ADVENTRX’s Web site at www.adventrx.com.
Forward Looking Statement
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, uncertainties, assumptions and other factors that, if they do not materialize or 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. Such forward-looking statements are made based on management’s current expectations and beliefs and should not be regarded as a statement or representation by ADVENTRX that any of its plans, including its anticipated milestones, will be achieved on time or at all. The potential risks and uncertainties that could cause actual results to differ materially include, but are not limited to: unexpected adverse side effects or inadequate therapeutic efficacy of CoFactor(R) or ADVENTRX’s other products that could delay or prevent regulatory approval or commercialization, or that could result in recalls or product liability claims; 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 or clinical data suggests or as otherwise anticipated; the potential for regulatory authorities to require additional preclinical work or other clinical requirements to support regulatory filings; the ability to timely enroll subjects in ADVENTRX’s current and anticipated clinical trials; the results of pending clinical trials for CoFactor(R) or ADVENTRX’s other product candidates; the potential for CoFactor(R) and ADVENTRX’s other 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; other difficulties or delays in developing, testing, manufacturing and marketing of and obtaining regulatory approval for CoFactor(R) or ADVENTRX’s other product candidates; 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; the potential to attract a strategic partner and the terms of any related transaction; the market potential for fluoropyrimidine biomodulators and other target markets, and ADVENTRX’s ability to compete in those markets; the scope and validity of patent protection for CoFactor(R) and ADVENTRX’s other product candidates; 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. All forward-looking statements are qualified in their entirety by this cautionary statement and ADVENTRX assumes no obligation to revise or update any forward-looking statement, including as set forth in this press release, to reflect events or circumstances arising after the date on which it was made.
ADVENTRX Pharmaceuticals, Inc.
CONTACT: Andrea Lynn of ADVENTRX Pharmaceuticals, +1-858-552-0866
Web site: http://www.adventrx.com/
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