The drug, CVBT-141B, is formulated with human fibroblast growth factor-1 (FGF-1) and was applied topically in eight subjects at a single site. CardioVascular BioTherapeutics said that the formulation was found to be well tolerated. FGF-1 offers the possibility of improved dermal ulcer healing by the promotion of new blood vessel growth, known as angiogenesis, in the wound bed resulting in enhanced development of granulation tissue, the company says.
Dr Jack Jacobs, chief operating and scientific officer, said: “We are very pleased to be through our Phase I trial and to see that no serious adverse events were noted in any of the patients receiving FGF-1 topically. With the successful completion of this Phase I study, the company can now move on to establish the efficacy of our drug candidate, and in this regard, we are currently finalizing a clinical study protocol for initiating a multiple dose safety and efficacy trial in an expanded patient population.”