The first clinical study was performed from 1995 to 1997 in Fulda, Germany by Dr. Thomas J. Stegmann. FGF-1141 was injected directly into the wall of the heart of 20 patients with coronary artery disease. These patients were also receiving a coronary by-pass procedure on another affected artery. A control group of 20 patients received bypass surgery alone.

The patients treated with FGF-1141 showed a significant increase in localized blood vessel growth at the site of injection, and importantly, these vessels persisted when examined at a three-year follow-up examination. The blood vessel growth was determined to be statistically significant over controls at both three months (P-value less than 0.005) and three years (P-value less than 0.005) following injection of FGF-1141. In the scientific and medical research communities, the term statistically significant means that a particular experimental test has a P-value of less than 0.05. P-values are calculated from experimental variations typically seen in scientific or medical testing. Thus, if the blood vessel growth in the German clinical tests had reflected P-values of greater than 0.05, the growth would have been deemed to be statistically insignificant. As a test’s P-value decreases below 0.05, the more statistically significant the result is deemed to be in the scientific and medical research communities.

The amount of blood vessel growth in the heart muscle was determined by angiograms wherein a dye was injected into the affected areas. New blood vessel growth was measured through digital photographic analysis of the dyed areas, a process referred to in the scientific research community as the mean gray value, or gray value, analysis. The gray value measurements for the heart muscles injected with FGF-1141™, and the control group which did not receive the injections, at three months after surgery and three years after surgery were as follows:

3 Months After Surgery/3 Years After Surgery
Test Group . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .59/65
Control Group . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20/18

This analysis of the results between the Test Group and the Control Group reflected an approximately threefold increase in vascular density in the treated areas in the Test Group as compared to the Control Group at both measurement times.

Statistical analysis of the gray value data was performed using standard Student’s t-tests. Student’s t-tests are commonly used in scientific research for statistical analysis. They are used to calculate P-values to determine statistical significance.

A limitation of the first clinical study was the difficulty in determining medical benefits due to the bypass surgery versus FGF-1141, as both were administered at the same time. Due to those limitations, a second clinical study of 20 patients was performed from 1998 through 1999, where FGF-1141 injection was used as the sole therapy. There was no control group in this study for ethical reasons, as administration of the placebo would have required surgery.

The results obtained from the second study demonstrated:

• No adverse events from the growth factor injection;
• 80% of patients showed a significant improvement in their exercise tolerance test (P-value less than 0.001);
• Blood flow into the heart muscle under stress showed a significant increase in tests that measure blood flow (P-value less than 0.001);
• No significant adverse safety effects of the therapy; and
• Importantly, 90% of patients (18 out of 20) had an improvement in their dominant clinical symptom, chest pain, showing an improvement of at least one class in an angina survey which divides chest pains into four increasingly severe categories. For two of the patients, their angina pain scores remained the same. During the stress exercise test for those patients, chest pain was either completely absent, or began at much higher levels of exertion for each patient.

Although both clinical studies in Germany reached their clinical endpoints, and no significant adverse safety events were observed, such studies were done with a limited population. While the results were encouraging in these earlier studies, there is no assurance that they will be replicated in our FDA trials, or, even if replicated, that the FDA will approve FGF-1141 for commercial use.

The results of these studies were published in peer reviewed cardiology journals. Follow these links to see the text of those studies.

• Induction of neoangiogenesis in ischemic myocardium by human growth factors. First clinical results of a new treatment of coronary heart disease. (1998)
• First angiogenic treatment of coronary heart disease by FGF1: Long term results after 3 years. (2000)
• Therapeutic Angiogenesis: Intramyocardial Growth Factor Delivery of FGF1 as Sole Therapy in Patients with Chronic Coronary Artery Disease. (2000)
• Intramyocardial injection of fibroblast growth factor-1 for refractory angina pectoris: The initial US experience. (2004)
• New Vessels for the Heart by Dr. Stegmann

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