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| |  No Statistically Significant Improvement With Recombinant Fibroblast Growth Factor-2 ANAHEIM, CA -- March 13, 2000 -- Chiron Corporation announced that a Phase II clinical trial of its recombinant fibroblast growth factor-2 (FGF-2), in symptomatic coronary artery disease (CAD) patients who were not candidates for angioplasty or bypass surgery, did not meet the study's primary efficacy objective of improving exercise time at 90 days. Positive trends were seen, however, in the clinically relevant secondary endpoints: reduction of angina (chest pain) frequency as measured separately by both patients and their physicians. There were no apparent differences between treatment and control groups with respect to reported adverse events. Chiron's Phase II FGF-2 study for patients with coronary artery disease is called "FIRST", which stands for the FGF-2 Initiating Revascularization Support Trial. This multi-center, placebo-controlled, double-blind study evaluated three doses (0.3, 3.0, and 30.0 micrograms/kg) of FGF-2 administered as a single intracoronary infusion. A total of 337 patients were enrolled in the study. The primary efficacy measure was exercise capacity, as assessed by an exercise tolerance test (ETT) administered at the beginning of the study and at 90 days after FGF-2 administration. Secondary endpoints included safety; patient assessment of health-related quality of life (as measured by the Seattle Angina Questionnaire); physician assessment of angina status (as measured by the Canadian Cardiovascular Classification Scale); and myocardial perfusion assessed by nuclear imaging. These same endpoints are also being assessed at 180 days. Preliminary review of the overall nuclear imaging data show no apparent difference between treatment and control groups. Death (less than 2 percent) and myocardial infarction (less than 7 percent) were consistent across the treatment and placebo groups. "Although we did not see a statistically significant improvement in exercise testing at 90 days, we are encouraged by the positive trends relating to reduction in angina frequency experienced by patients who received FGF-2," stated Lewis T. "Rusty" Williams, M.D., Ph.D., Chiron's chief scientific officer. "The use of angiogenic agents to treat ischemia in the heart and limbs is an emerging field that has great promise. In order to develop a new, safe and effective class of therapies, it's not surprising that we will have to take a stepwise approach, learning from each trial. We intend to complete the analysis of all the FGF-2 data, including the 180-day measurements, in order to determine the best path forward." Dr. Williams added, "Chiron has an on-going Phase II trial of FGF-2 in patients with peripheral artery disease (PAD). Enrollment of this trial is nearing completion, and we anticipate that the results will be available in the second half of the year." Nicolas Chronos, M.D., co-principal investigator of the Phase II trial and director of the Atlanta Cardiovascular Research Institute, commented, "I am pleased by some of these early findings, particularly in regard to their clinical relevance. Angina frequency is the most important symptom that patients with coronary artery disease experience, and having an effective therapeutic to manage this condition would be valuable to physicians and patients alike. Exercise time, in contrast, is a surrogate marker for the patient's overall clinical condition and may not accurately measure coronary blood flow." "The patient-reported reduction in angina was supported by physician data gathered on a post hoc basis," said Michael Simons, M.D., co-principal investigator of the Phase II trial and director of the Angiogenesis Research Center at Beth Israel Deaconess Medical Center, located in Boston. "This is the first time an improvement in clinically relevant symptoms in CAD patients has been observed with growth factor therapy in a placebo-controlled trial. Seeing the favorable trends recorded independently by patients and doctors alike increases our optimism that FGF-2 may have potential as a therapeutic option in treating this growing patient population." Related Link: Chiron Corporation.
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