• E-mail
• Print
• Comment
• Font Size
• Digg
• del.icio.us
• Discuss article

University of Cincinnati and CardioVascular BioTherapeutics to Host Reunion Celebration for Patients Involved in Phase I Clinical Trial

Posted on: Thursday, 17 August 2006, 12:00 CDT

"No Option Heart Patients" Participated in Cardio Vascu-Grow Phase I Clinical Trial for Innovative Protein Therapy to Stimulate Growth of New Blood Vessels

CardioVascular BioTherapeutics, Inc. (OTCBB:CVBT), in conjunction with the University of Cincinnati, today announced it will be hosting a reunion celebration honoring the patients who participated in a clinical trial during which they received Cardio Vascu-Grow(TM), an innovative protein therapy being evaluated for its potential to stimulate the growth of new blood vessels around blocked arteries in the heart. The event will take place on September 7, 2006 at the Marriott Kingsgate Conference Center Hotel at the University of Cincinnati. A press conference will be held at 11:00 a.m. followed by a luncheon celebration at 12:00 noon.

A total of 21 no option heart patients were enrolled and treated in an unblinded, FDA-authorized Phase I dose escalation trial to evaluate the safety and tolerability of our drug candidate with Cardio Vascu-Grow(TM) as its active ingredient. These patients were deemed ineligible for traditional interventional therapies such as bypass and stenting procedures due to unfavorable coronary pathology.

"Before the treatment with Cardio Vascu-Grow(TM), these patients suffered from constant chest pains and shortness of breath, among other symptoms, and after treatment, their conditions improved," said Dr. Lynne Wagoner, M.D., an associate professor of medicine and medical director of the Cardiac Transplant and Heart Failure Program at the University of Cincinnati. "In my opinion, this is a very exciting and promising treatment for patients both with heart disease and other cardiovascular diseases."

Cardio Vascu-Grow(TM) contains a protein, FGF-1, that has been shown in pre-clinical trials to stimulate blood vessel growth and in other clinical trials to increase the blood supply to damaged tissues. With the Phase I trial nearing completion in the US, CVBT is now recruiting clinical trial sites around the world to participate in a Phase II trial that will contain a larger cohort of no-option heart patients.

"We are excited to celebrate this significant milestone with these patients, and to recognize their contributions and efforts to make this therapy available to all," said Daniel C. Montano, President and CEO of CardioVascular BioTherapeutics, Inc. "With more than 77 million people suffering from cardiovascular diseases, new treatment options are critical, but only with the help of individuals such as these patients are new medical therapies made possible."

About CardioVascular BioTherapeutics

CVBT is a biopharmaceutical company developing drug candidates with Cardio Vascu-Grow(TM) as the active ingredient for a number of diseases characterized by inadequate blood flow to a tissue or organ. Currently, the company is conducting two FDA-authorized clinical trials: one in coronary artery disease in no-option heart patients, and one in impaired wound healing seen in diabetics. Additionally, the company has completed pre-clinical studies in animal models of peripheral artery disease of the legs and stroke recovery. A foreign clinical trial relating to chronic back pain believed to be caused by impaired or blocked lumbar arteries has also been initiated.

Cardio Vascu-Grow is a trademark of CardioVascular BioTherapeutics, Inc.

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 expectations for new research, progress with clinical trials or future business initiatives are forward looking statements. Factors that might affect actual outcomes include, but are not limited to, results of future clinical and pre-clinical trials, differences in patient outcomes, FDA approval of CVBT drug candidates, market acceptance of CVBT 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.

Source: Business Wire

More News in this Category