The data from CVBT’s Phase II trial suggested that CVBT’s FGF-1 biological drug showed efficacy at a level greater than has been seen in any other treatments, for patients suffering from chronic ischemic diabetic wounds.
In the Phase IIa trial, diabetic wounds treated with FGF-1 healed approximately 4.5 times faster than wounds treated with placebo/standard of care (which included debridement).
Additionally, in the Phase IIb trial, all of the diabetic wounds treated with FGF-1 achieved 100% closure within five months or less, whereas a full one-third of the placebo-treated wounds remained open at the end of the same treatment period.
CVBT CEO Daniel Montano said that CVBT-141B appears to be delivering a major treatment breakthrough for the treatment of chronic ischemic diabetic wounds.
"With this Phase I and Phase II clinical trial data, CVBT plans to request FDA approval to commence a pivotal Phase III trial for CVBT-141B. Additionally, CVBT plans to apply for ‘Fast Track Development Program’ status for CVBT-141B," Montano said.