Healthcare Industry News: CardioVascular BioTherapeutics
News Release - May 18, 2006
CVBT Achieves Safety Milestone in Clinical Heart Trial
LAS VEGAS--(HSMN NewsFeed)--May 18, 2006--CardioVascular BioTherapeutics, Inc. (OTCBB:CVBT ) has achieved 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. Enrollment and treatment of all patients as specified in the FDA-authorized clinical protocol has been completed.Dan Montano, CVBT's Chief Executive Officer, commented, "We are very pleased with the safety profile of our lead drug candidate formulated with Cardio Vascu-Grow(TM) in the no-option heart patients that were treated at the six U.S. Medical Centers that participated in this trial. 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(TM) 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(TM) for a number of diseases characterized by inadequate blood flow to a tissue or organ. The company has two (2) FDA clinical trials underway with its drug candidates in the medical indications of advanced coronary artery disease and impaired wound healing seen in diabetes. 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(TM) 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.
This news release contains forward-looking statements that involve risks and uncertainties. Actual results and outcomes may differ materially from those discussed or anticipated. For example, statements regarding our expectations or effectiveness of our drug candidates, our progress with clinical trials or our future business initiatives are forward looking statements. Factors that might affect actual outcomes include, but are not limited to, FDA approval of our drug candidates, market acceptance of CardioVascular BioTherapeutics, Inc. products by customers, new developments in the industry, future revenues, future expenses, future margins, cash usage and financial performance. For a more detailed discussion of these and associated risks, see the company's most recent documents filed with the Securities and Exchange Commission.
Cardio Vascu-Grow(TM) is a trademark of CardioVascular BioTherapeutics, Inc.
Source: CardioVascular BioTherapeutics
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