CardioVascular BioTherapeutics, Inc. (CVBT), a biopharmaceutical company, has signed a master service agreement with leading global clinical research organization (CRO) Kendle. Kendle will support CVBT in its phase II clinical trial ensuring that the protocol and study adhere to FDA regulatory requirements. Kendle has worked with CVBT to finalize the protocol that will be submitted to the FDA. The clinical trial is evaluating CVBT's drug candidate, with Cardio Vascu-Grow as its active ingredient, that is injected into no-option heart patients to stimulate the growth of new blood vessels, a process called angiogenesis.
The phase II clinical trial is planned to be an international, multi-site clinical trial performed in the US, Canada and Europe, for patients not eligible for traditional interventional therapies such as bypass or stenting procedures. Kendle is now screening sites for participation in the phase II clinical trial.
Thomas J. Stegmann, M.D., co-founder and chief clinical officer of CVBT stated, "By our collaboration with Kendle, a premier global full-service clinical research organization, and expansion of the number of clinical trial sites within the United States and internationally, we hope to accelerate the enrolment of patients in the Phase II trial as compared to enrolment in phase I, which was completed in March of 2006."