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Below is a summary of the current status of our three clinical trials. Dermal Wound Healing – CVBT initiated its diabetic wound healing program in 2004 and completed pre-clinical efficacy and toxicity studies with human fibroblast growth factor (FGF-1). An FDA-authorized Phase I study in diabetic patients was completed in 2008 in which topically-applied FGF-1 to diabetic wounds was well tolerated and showed no adverse effects. Severe Coronary Heart Disease (CHD) – A U.S. FDA approved Phase II trial for heart patients with severe coronary heart disease has begun in an expanded patient population in the United States and internationally. The following sites are now open for patient enrollment. Peripheral Artery Disease –The US FDA has authorized a Phase I clinical trial for Peripheral Artery Disease (PAD) specifically for patients with intermittent claudication (cramping pain and weakness in the legs during walking). Note: While the FDA ultimately determines the course and timing of clinical trials, this timeline represents an estimate as to when certain research milestones could be achieved in the development of those applications. The information is subject to change at any time and is likely to change. Actual results may differ materially. It is provided for information purposes only. Investment decisions should not be made based on the timeline. CVBT does not undertake to update the timeline on this web site. This information is only an estimate.
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