Overview

We have completed an FDA authorized Phase I clinical trial, in which we tested the safety of our wound healing drug candidate CVBT-141B in eight subjects with diabetic foot ulcers or venous stasis leg wounds. Each subject received either a low or high dose topical application of our wound healing drug candidate.  No drug-related adverse events were observed.  A Phase Ib/II clinical protocol to continue development of this drug candidate is now being prepared for submission to the FDA.  In this trial both safety and efficacy of multiple doses of FGF-1 will be tested. Prior to our Phase I trial, we completed animal studies that demonstrated CVBT-141B was a safe and efficacious agent in healing dermal wounds in diabetic mice. In addition, it was demonstrated that little, if any, of our wound healing drug candidate was absorbed into the blood stream after topical application to the wound surface. Similar absorption studies were conducted in patients in our Phase I clinical trial.

Procedure

Once the Phase Ib/II protocol is developed, we will place the details of the procedure here. Please check back for updates.

Enrollment

Enrollment for our Phase I wound healing trial is currently closed. We are not yet enrolling patients for the Phase Ib/II trial but will update this section of the website as soon as information becomes available.

Trial Locations

Locations for our Phase Ib/II trial have not been determined. Please check back for updates. If you would like to receive an email alert when enrollment opens for our Wound Healing trial, please complete our Clinical Trial Inquiry Form.

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