FGF: Physican Information

Principal Investigator: Tim Henry, M.D.

Co-Investigators: Brad Bart, M.D., Charles Herzog, M.D., Richard Manka, M.D.

Coordinators: Talia Pierce, R.N., Charlene Boisjolie, R.N., Maria Pyle, L.P.N., Lorri Knox, R.N.

Study Drug: Recombinant Fibroblast Growth Factor (FGF)

Study Population: CAD with chronic, stable angina and areas of viable, but underperfused myocardium who are not ideal candidates for revascularization.

Study Objective: To assess the clinical effect of treatment with rFGF vs. placebo as measured by the change in exercise tolerance (exercise treadmill time) from baseline to Day 90 in subjects with coronary artery disease who are not optimal candidates for PTCA or CABG.

Study Design: Phase II, double-blind, placebo-controlled, multicenter. Single intracoronary infusion in 300 patients with CAD First trial of efficacy of rFGF. Subjects are followed for 180 days.

Entry Criteria:

Inclusion:

Age >18
Stable, ischemic CAD
Symptoms of angina or anginal equivalent
Viable but underperfused myocardium
Not optimal candidate for revascularization

Exclusion (select):

Malignancy: evidence or history of cancer within the last 10 years
Renal dysfunction: creatinine of >1.5 mg%, proteinuria
Ocular conditions: diabetic retinopathies
Cardiovascular conditions:
1. Unstable angina within 3 weeks
2. Previous involvement in TMLR, EECP, therapeutic angiogenesis trials
3. EF <30%
4. Severe valvular heart disease
5. MI/CABG/PTCR/TIA/stroke within the past 6 months

Drug Therapy: Patients will be randomized to placebo or to one of three doses of FGF, delivered as a single 20-minute intracoronary infusion.

Concomitant Therapies: Patients will be treated by their personal physicians with routine medication as needed. No restriction of medication will be stipulated.

Other Study Requirements:

Prestudy eye exam, routine cancer screening tests, nuclear scan, coronary angiogram, laboratory evaluation
Baseline and follow-up coronary angiogram, exercise treadmill and pharmacologic stress nuclear scanning, ophthalmologic exam with retinal photos, CXR

Contact: FGF-VEGF@MMRF.org

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