Heart

An Estimated 15.8 Million Americans suffer from Coronary Heart Disease (CHD)

The research to develop FGF-1141 started in 1992 in Germany with Dr. Thomas J. Stegmann’s initial success in growing new blood vessels in animal hearts. This research led to the first human experiments in 1995-96 in 20 patients with no-option heart disease. The results were reported in the American Heart Association’s publication, Circulation, in February 1998. This first successful angiogenesis clinical trial in the human heart led to the founding of CardioVascular BioTherapeutics, Inc. to commercialize this medical breakthrough.

In 1998-99, Dr. Stegmann conducted a second clinical trial using the drug as the sole therapy in 20 no-option heart patients. The successful results of this trial were reported in the cardiology journal, Cardiac and Vascular Regeneration in 2000. The cumulative results of the two clinical trials can be summarized as follows:

The potential of FGF-1141 as a new treatment for coronary heart disease was convincingly demonstrated by Dr. Thomas Stegmann and his associates in two separate clinical trials performed in Germany. A total of 40 patients with no viable surgical treatment options received injections into their hearts of human fibroblast growth factor, the active ingredient in FGF-1141. The clinical results from these studies published in internationally-recognized medical journals, indicated that FGF-1141 was a safe and effective treatment for severe coronary artery disease.

The following results were observed:

• 80% of patients showed a significant improvement in their stress exercise test.
• Hearts showed a five-fold increase in the stress SPECT perfusion score, indicating a significant improvement in blood flow to the heart muscle.
• No significant adverse safety effects of the therapy.
• Importantly, 90% of the patients had an improvement in their dominant clinical symptom, angina or chest pain. During the stress exercise test, angina was either completely absent, or began at much higher levels of exertion.
  

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