CARDIOVASCULAR BIOTHERAPEUTICS, INC. (OTCBB: CVBT)

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As the pharmaceutical and health care market begins to surge under the massive demographic that is the aging Baby Boomers, clinical trials to treat an array of maladies may soon grab headlines. Savvy companies are swiftly executing research and development to service huge needs within this enormous group.

For example, CardioVascular BioTherapeutics, Inc. (OTC BB:CVBT) recently announced that it has initiated a clinical trial to study the safety of a new drug candidate using Cardio Vascu-Grow™ as its active ingredient for the treatment of Peripheral Artery Disease (PAD), a disease affecting 8 million Americans.  Undoubtedly, investors and PAD patients alike will be watching intently to see the results of this compelling trial.

To review our full profile on CVBT click here.

*LATEST* News from CVBT

Press Release Source: CardioVascular BioTherapeutics, Inc.
Tuesday October 24, 11:00 am ET

LAS VEGAS--(BUSINESS WIRE)--CardioVascular BioTherapeutics, Inc. (OTCBB:CVBT - News) today announced that it is launching a new clinical trial to study the safety of a new drug candidate using Cardio Vascu-Grow(TM) as its active ingredient for the treatment of Peripheral Artery Disease (PAD). Cardio Vascu-Grow(TM) contains a protein that stimulates the growth and production of new blood vessels, a process called angiogenesis.

An estimated 8 million Americans suffer from peripheral artery disease, which occurs when blood vessels which feed the legs become blocked by atherosclerotic lesions, resulting in pain while walking, a condition termed "intermittent claudication." This can evolve to more severe forms of the disease where circulation to the foot and leg become so reduced that amputation of the toes, foot, or leg is the only alternative. This disease increases in prevalence as people age or in patients with diabetes. This FDA-authorized Phase I clinical trial will test the safety of Cardio Vascu-Grow(TM) after it is injected into the legs of PAD patients, and will evaluate the growth of new blood vessels in the legs and the increase of blood perfusion into the ischemic leg muscles in these patients.

"Peripheral artery disease is a major health concern faced by millions of Americans, and left untreated, it increases the risk of heart attack, stroke, amputation, or death," said Dr. Thomas J. Stegmann, co-founder of CardioVascular BioTherapeutics. "Better treatment options are needed for this disease, and regenerative treatments such as Cardio Vascu-Grow(TM), which enhance the body's natural ability to regenerate tissues and organs, have the potential to radically reduce the mortality, and morbidity, and increase the quality of life of patients with peripheral artery disease."

This multi-center study will involve medical centers in the United States. Three escalating doses of Cardio Vascu-Grow(TM) will be tested in 24 patients that suffer from intermittent claudication. In addition, a group of control patients will receive a placebo dose of the drug to allow comparisons of safety and efficacy to guide subsequent clinical studies. The Phase I study will incorporate relatively new imaging modalities, including magnetic resonance imaging of the patient's legs before and after treatment with Cardio Vascu-Grow(TM), in an effort to more accurately quantify the potential increase in blood perfusion that is anticipated in patients injected with the drug.

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 three FDA-authorized clinical trials: one in the area of coronary artery disease in no-option heart patients, one in the area of impaired wound healing seen in diabetics, and one in patients with peripheral artery disease. In addition, the company has initiated a clinical trial in Russia examining the potential of Cardio Vascu-Grow(TM) to improve symptoms in patients with chronic back pain believed to be caused by impaired or blocked lumbar arteries. The company has also recently completed pre-clinical studies with Cardio Vascu-Grow(TM) demonstrating efficacy in animal models of stroke recovery.

Cardio Vascu-Grow(TM) 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, 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.

Contact:

CardioVascular BioTherapeutics, Inc.
Investor Relations, 702-391-4999
investorrelations@cvbt.com
or
Schwartz Communications
Lauren Arnold or Sadie Anderson, 781-684-0770
cvbt@schwartz-pr.com

Source: CardioVascular BioTherapeutics, Inc.
 

About CardioVascular BioTherapeutics

In two separate clinical trials in Germany in the mid-1990s conducted by Dr. Thomas J. Stegmann, a protein identical in structure to Cardio Vascu-Grow™ prompted the growth of new blood vessels in the hearts and increased the pumping capacity of the hearts in the "no option" heart patients treated. 

CVBT is currently working to confirm the medical benefits of this protein drug candidate through human clinical trials authorized by the U.S. Food and Drug Administration (FDA). The FDA clinical trial for no-option heart patients commenced in August 2004, with a network of six major medical centers conducting the trial.  To date, 60 human no-option heart patients have been treated with Cardio Vascu-Grow™ and in Dr. Stegmann's German trial using a protein identical in structure to Cardio Vascu-Grow™.

CVBT recently announced that its Investigational New Drug Application ("IND") to the U.S. FDA had been allowed and the company is now authorized to commence its Phase I clinical trial in diabetic patients with foot ulcers and/or open leg wounds.  Wound healing requires angiogenesis for the healing process to occur, making this indication an attractive target for treatment with Cardio Vascu-Grow™.  In animal models, Cardio Vascu-Grow™ has been shown to be a potent stimulator of wound healing, almost doubling the rate at which a wound will heal.  People with diminished healing abilities, including diabetics and the elderly, could greatly benefit from an agent that could stimulate the growth of new blood vessels in the wounded area.  10 Million Patients Suffer from Diabetic Leg Ulcers, Bed Sores and Surgical Wounds.

CVBT is committed to conducting additional clinical trials to establish the positive effect of its drug candidate aimed at improving the quality of life for those suffering from heart disease, stroke, diabetic wounds, or peripheral vascular disease, and CVBT management pledges to continue exploration for additional applications of Cardio Vascu-Grow™.
 

The Need for Cardio Vascu-Grow™

• 38% of all deaths in the United States are caused by cardiovascular disease 
• 13.2 million suffer from coronary artery disease
• 4.8 million people in the U.S. have suffered strokes
• 7.8 million people in the U.S. will have a heart attack this year

Other Recent News From CVBT

Business Wire - September 06, 2006 8:00 AM ET
SOURCE: CardioVascular BioTherapeutics, Inc.

CardioVascular BioTherapeutics, Inc. (OTCBB:CVBT) today announced that it has engaged The Bruckner Group (BGI) to help develop the value proposition for its drug candidates for the treatment of cardiovascular diseases formulated with Cardio Vascu-Grow(TM). The Bruckner Group is the leading expert in developing strategies for pharmaceutical and biotechnology companies to maximize, define, prove, and leverage the healthcare value of their therapeutics. BGI will work with CardioVascular BioTherapeutics to economically evaluate Cardio Vascu-Grow(TM) in order to secure the broadest possible payer coverage and clinical utilization.

CardioVascular BioTherapeutics is developing drug candidates with Cardio Vascu-Grow as the active ingredient for products for the treatment of a number of diseases characterized by inadequate blood flow to a tissue or organ. The company has FDA clinical trials underway for advanced coronary artery disease for patients who currently have no or limited treatment options, and for impaired wound healing seen in patients with diabetes. CVBT is also conducting a proof-of-concept trial in Europe in patients with chronic back pain believed to be caused by blockage of lumbar arteries. Pre-clinical testing has been completed with Cardio Vascu-Grow in two additional areas -- peripheral artery disease of the legs and stroke recovery.

"In order to secure the best possible coverage from healthcare payers, we need to clearly deliver proven healthcare value," said Daniel C. Montano, president and CEO of CardioVascular BioTherapeutics. "We look forward to working with The Bruckner Group to incorporate economic evaluations into our development process, which will help us to determine the data and evidence that we need to sufficiently prove the economic benefits to payers for covering Cardio Vascu-Grow for patients suffering from cardiovascular disease."

"CardioVascular BioTherapeutics is developing drug candidates that have the potential of impacting millions of people suffering from cardiovascular disease, and it is imperative that its drug candidates be economically as well as clinically viable in the medical community," said David Balekdjian, partner of The Bruckner Group. "Our expertise in understanding how payers evaluate and make coverage decisions for pharmaceuticals and biologicals will enable BGI to play a valuable role in helping CardioVascular BioTherapeutics develop a value proposition that will enable the company to succeed."

You may view the entire news release HERE

Press Release 
Source: CardioVascular BioTherapeutics, Inc.
Thursday September 7, 9:00 am ET

LAS VEGAS--(BUSINESS WIRE)--Sept. 7, 2006--CardioVascular BioTherapeutics, Inc. (OTCBB:CVBT - News) today announced it has signed a master service agreement with leading global clinical research organization (CRO) Kendle (NASDAQ: KNDL - News). 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(TM) 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 U.S., 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 enrollment of patients in the Phase II trial as compared to enrollment in Phase I, which was completed in March of 2006."

You may view the entire news release HERE

LAS VEGAS & CINCINNATI--(BUSINESS WIRE)--Aug. 17, 2006--CardioVascular BioTherapeutics, Inc. (OTCBB:CVBT - News), 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."

You may view the entire news release HERE
 

CVBT Leadership

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Thomas J. Stegmann, M.D.

Dr. Thomas J. Stegmann’s discovery of ways to stimulate growth of new blood vessels in the human heart opens up an exciting new area of biotechnology and medical treatment for cardiovascular disease.  His research and subsequent trials have been articulated in an acclaimed volume, New Vessels for the Heart: Angiogenesis as New Treatment for Coronary Heart Disease: The Story of its Discovery and Development, published in 2005.

Dr. Stegmann is the cardiac surgeon who pioneered the procedure upon which CVBT was founded.   For the past 12 years, he has been working in the area of neo-angiogenesis and human growth factors, prompting a discovery that opens a new area of biotechnology and medical treatment for the treatment of cardiovascular disease. Besides various scientific publications, he has since authored New Vessels for the Heart, the story of his discovery and its development.

Since December 1984, Dr. Stegmann has held the position of Professor of Surgery and Director of the Department for Thoracic and Cardiovascular Surgery at the Fulda Medical Center in Germany, a major medical and teaching hospital serving the University of Marburg and the greater Frankfurt, Germany area. He is also a member of the faculty of Hannover Medical School in Germany. He received his medical degree (summa cum laude) from Heidelberg University, Heidelberg, Germany.

Daniel C. Montano brings a wide range of management experience to his roles, having served as CEO of 14 operating companies in industries such as real estate, high technology, medical technology, biotechnology, food products, financial institutions, and service companies.  From 1981 until 2004, Montano was a member of the Board of Directors of Helen of Troy, Ltd, a Texas company with revenue of over $450 million.  He also spent 30 years as an investment banker.  Montano received his MBA from the University of Southern California and his undergraduate degree from California State University, Los Angeles.
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