Updated Phase II COFU Trial Data
Jun 20, 2005 - 6:55:38 PM
ADVENTRX Pharmaceuticals, Inc. (Amex:ANX) today announced response data from all 48 measurable patients in its 50-patient Phase II trial with CoFactor(TM) and 5-fluorouracil (5-FU) as a first-line treatment for metastatic colorectal cancer. CoFactor is ADVENTRX's biomodulator designed to enhance the effects of the widely used cancer drug, 5-FU. A poster of these results was presented at the 7th World Congress on Gastrointestinal Cancer in Barcelona, Spain.
Updated Phase II COFU trial data
-- Sixty-five percent, or 31 patients, treated with CoFactor and 5-FU achieved clinical benefit, defined as tumor response or stable disease following study therapy.
-- Objective response data showed 38%, or 18 patients, responded to treatment with CoFactor and 5-FU, surpassing the trial's primary endpoint objective of 25%. Objective response is defined as all patients having complete or partial responses, whose tumor measurements are confirmed by MRI or CT scan by repeat assessment performed no less than four weeks after the criteria for response is first met. A complete response is a complete disappearance of the tumor; partial response is at least a 50% reduction in total tumor size as defined by World Health Organization (WHO) criteria.
-- Thirteen patients exhibited stable disease and 17 have progressive disease. Stable disease is less than a 50% reduction in total tumor size; and progressive disease is at least a 25% increase in tumor size at the end of the treatment cycle, as measured by CT or MRI scans.
-- No grade 3 or 4 gastrointestinal or hematological toxicities were recorded demonstrating the treatment regimen of CoFactor plus 5-FU was well tolerated. Toxicity grades were determined in accordance with the National Cancer Institute's Common Terminology Criteria for Adverse Events grading system. The most common adverse events were diarrhea, nausea and vomiting, none of which were grade 3 or 4. There was a single case of grade 3 watery eye, and a grade 3 bowel obstruction not related to study drug. This safety data was measured in all 50 patients enrolled in the trial.
"These results further confirm that CoFactor plus 5-FU present a viable alternative for patients with metastatic colorectal cancer as it achieves increased response rates without high levels of toxicity, compared with leucovorin plus 5-FU," said Evan M. Levine, president and CEO for ADVENTRX. "Patients in this trial continue to be followed for time-to-tumor progression and overall survival and we look forward to announcing this data later this year."
Cellia Habita, M.D., Ph.D., senior vice president of medical and clinical affairs of ADVENTRX, presented poster # 371 entitled, "A Simon two stage study of CoFactor (CO) with 5-fluorouracil (FU) as first line treatment in metastatic colorectal cancer (mCRC)." This abstract is available via ADVENTRX's Web site at www.adventrx.com.
CoFactor (ANX-510) is a folate-based biomodulator drug developed to enhance the activity of the widely used cancer chemotherapeutic 5-FU. Data from previous clinical trials in Europe have demonstrated clinical benefit and improved overall median survival in patients with advanced tumors, including colorectal, pancreatic and breast. 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.
About the Phase II COFU trial
The Phase II clinical trial is an open label, single arm Simon 2 stage study design to assess the safety and efficacy of CoFactor plus 5-FU as a first line treatment of metastatic colorectal cancer. Patients enrolled in this trial are age 18 and older with ECOG 0-2 and measurable metastatic colorectal cancer, with or without adjuvant 5-FU/leucovorin, irinotecan, or oxaliplatin, but no prior chemotherapy for metastatic disease. Patients may receive more than two cycles each consisting of CoFactor 60 mg/m2 and 5-FU 450 mg/m2 (weekly IV bolus) for six consecutive weeks, followed by a 14 day rest period, which is defined as a cycle. Pre-established response criteria are greater than four responders of 23 patients for stage one, and greater than 12 responders of 48 patients for the full trial. The trial is being conducted in the U.S. and Europe under a U.S. investigational new drug application.
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