ADVENTRX Presents Response Data for Total Enrollment in CoFactor Phase II Metastatic Colorectal Cancer Trial; Poster Presented at 7th World Congress on Gastrointestinal Cancer.SAN DIEGO -- ADVENTRX Pharmaceuticals, Inc. (Amex:ANX ANX Annex ANX Adventrx Pharmaceuticals (San Diego, CA) ANX Automotive Network Exchange (AIAG) ANX Advanced Network Exchange ANX Ascending Node Crossing (satellites) ) today announced response data from all 48 measurable patients in its 50-patient Phase II trial with CoFactor cofactor An atom, organic molecule, or molecular group that is necessary for the catalytic activity (see catalysis) of many enzymes. A cofactor may be tightly bound to the protein portion of an enzyme and thus be an integral part of its functional structure, or it may (TM) and 5-fluorouracil (5-FU) as a first-line treatment for metastatic Metastatic The term used to describe a secondary cancer, or one that has spread from one area of the body to another. Mentioned in: Coagulation Disorders metastatic pertaining to or of the nature of a metastasis. 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 1. (application) MRI - Magnetic Resonance Imaging. 2. MRI - Measurement Requirements and Interface. 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 hematological, hematologic pertaining to or emanating from blood cells. hematological tests total and differential white cell counts, hematocrit estimation, erythrocyte count. 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 Nausea and Vomiting Definition Nausea is the sensation of being about to vomit. Vomiting, or emesis, is the expelling of undigested food through the mouth. , 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 (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. 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. About CoFactor 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 folate /fo·late/ (fo´lat) 1. the anionic form of folic acid. 2. more generally, any of a group of substances containing a form of pteroic acid conjugated with l-glutamic acid and having a variety of substitutions. , 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 the Phase II COFU trial The Phase II clinical trial Noun 1. phase II clinical trial - a clinical trial on more persons than in phase I; intended to evaluate the efficacy of a treatment for the condition it is intended to treat; possible side effects are monitored phase II 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 ECOG Eastern Cooperative Oncology Group 0-2 and measurable metastatic colorectal cancer, with or without adjuvant adjuvant /ad·ju·vant/ (aj?dbobr-vant) (a-joo´vant) 1. assisting or aiding. 2. a substance that aids another, such as an auxiliary remedy. 3. 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 bolus /bo·lus/ (bo´lus) 1. a rounded mass of food or pharmaceutical preparation ready to swallow, or such a mass passing through the gastrointestinal tract. 2. a concentrated mass of pharmaceutical preparation, e. ) 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. 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 bioavailability /bio·avail·a·bil·i·ty/ (bi?o-ah-val?ah-bil´i-te) the degree to which a drug or other substance becomes available to the target tissue after administration. bi·o·a·vail·a·bil·i·ty n. or 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 The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and 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 FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. 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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