CardioVascular BioTherapeutics, Inc. (CVBT) achieves a safety milestone in its phase I clinical trial carried out in patients with severe coronary artery disease. This phase I clinical trial included three escalating dose groups and no significant unexpected adverse events were attributable to CVBT's drug candidate in the patients who received treatment. Enrolment and treatment of all patients as specified in the FDA-authorized clinical protocol has been completed.
Dan Montano, CVBT's CEO, commented, "We are very pleased with the safety profile of our lead drug candidate formulated with Cardio Vascu-Grow in the no-option heart patients that were treated at the six US Medical Centres. This result provides the data to allow us to apply to the FDA to move forward into a phase II clinical trial. The phase II clinical trial will include an examination of not only the safety but of the efficacy of our drug candidate in a much larger population of patients with inoperable coronary heart disease. We believe our lead drug candidate formulated with Cardio Vascu-Grow will prove to be an effective therapeutic option for this class of patients who currently have no or limited treatment options and limited life expectancies."
CVBT is a biopharmaceutical company developing different formulations of Cardio Vascu-Grow for a number of diseases characterized by inadequate blood flow to a tissue or organ. CVBT is also conducting a proof-of-concept trial in Europe for chronic back pain caused by blockage of lumbar arteries. Pre-clinical testing has been completed with Cardio Vascu-Grow in 2 additional areas -- peripheral vascular disease of the legs and stroke. Clinical studies for these medical indications are planned to begin later this year.