FDAnews
www.fdanews.com/articles/81394-cvbt-s-vascu-grow-trial-to-proceed

CVBT'S VASCU-GROW TRIAL TO PROCEED

October 4, 2005

CardioVascular BioTherapeutics (CVBT) has announced that an ongoing Phase I clinical trial in no-option heart patients has been given approval to proceed to the final dosing group. The current trial is a multicenter, dose-escalation trial to evaluate the safety and tolerability of Cardio Vascu-Grow, a protein drug candidate that induces angiogenesis, or new blood vessel growth.

Patients enrolled are considered no-option patients because they are not deemed eligible for traditional interventional therapies such as bypass or stenting procedures. Although this is primarily a safety study, the company is also collecting and evaluating efficacy data in the trial that is valuable in planning future clinical studies.