CARDIOVASCULAR BIOTHERAPEUTICS, INC. (OTCBB: CVBT)

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As a result of ever-increasing healthcare costs, managed care payers have stepped up their efforts to control certain costs related to "biologics" - a wide range of medicinal products that includes vaccines, blood and blood components, allergenics, cells and gene therapies, tissues, and proteins created in the laboratories of biotechnology companies using cutting-edge technologies.  The ability to demonstrate "value" based upon positive outcomes of patients using a particular biologic becomes a critical issue in making a decision about covering costs of such biologics.  

In this month's issue of the medical journal Nature Biotechnology, CardioVascular BioTherapeutics, Inc’s (OTCBB:CVBT) is featured as an example of a smaller, nimble biotech company that is ideally positioned to quickly adapt its development and commercialization processes to the current environment, centralizing healthcare value and capitalizing on the opportunities under the new review system. 

CVBT’s inclusion in this widely-read journal points to is growing importance within the biotherapeutics space.
 

You may view the February 2008  Nature Biotechnology article HERE

Other recent articles on CardioVascular BioTherapeutics

Press Release Source: CardioVascular BioTherapeutics, Inc.
Wednesday January 9, 8:00 am ET

LAS VEGAS--(BUSINESS WIRE)--CardioVascular BioTherapeutics, Inc. (OTCBB: CVBT - News) is pleased to announce that its breakthrough angiogenesis therapy has been featured in the February 2008 issue of “Reader’s Digest.” The article, titled, “Heart Hope” by Lisa Collier Cool, refers to CVBT’s therapy as a “new lease on life” for patients suffering from severe coronary heart disease who do not have any other viable treatment options. Patients such as those featured in the Reader’s Digest article could benefit from this innovative treatment where conventional methods have failed them. Angiogenesis refers to the growth of new blood vessels that may help those suffering from coronary heart disease by increasing blood flow to the affected tissue.

Jim Blevins and Gail Keller, both patients of Dr. Lynne Wagoner, were what some refer to as “no option patients” for whom all of the “conventional treatments had been exhausted.” Dr. Wagoner was the principal investigator in CVBT’s completed Phase I Coronary Heart Disease trial. She learned of CVBT’s new procedure in which its drug, containing the active protein fibroblast growth factor-1 (FGF-1), was injected into the heart thereby stimulating angiogenesis. In the article, Thomas J. Stegmann, MD, co-founder, co-president, and chief medical officer of CVBT explains, “the protein is like a seed that causes new vessels to sprout, creating a network of capillaries and small arteries.” Once admitted into the trial, Gail Keller felt “thrilled and elated to finally have hope.” In the article Gail continued, “I had nothing to lose, because the quality of my life was so bad.” Before participating in the trial, Jim Blevins had been “dreading the future thinking that I’d go into heart failure again and only have a few years left.” Jim continued, “within a few months of being treated, my energy was up at least 50 percent.” Both Jim and Gail had successful outcomes from the Phase I trial and have been able to get back to activities that were once thought to be lost to them forever such as golf, biking and gardening.

Improving the quality of life for these patients through improvement of myocardial blood supply is CVBT’s main objective. “We are pleased about being highlighted by ‘Reader’s Digest’ for our intensive work in the field of angiogenesis therapy,” said Dr. Stegmann. “Our goal is to provide a viable treatment that gives heart disease patients hope and can return them to the quality of life they once enjoyed.”

The Phase II study will utilize an injection catheter to deliver the drug to ischemic regions in the heart wall without surgery. It is less invasive than the surgical delivery of the drug used in the Phase I trial. The Phase II trial will also permit the comparison of the benefits of CVBT’s drug candidate with the requirement of a placebo control group. CardioVascular BioTherapeutics is expected to begin its Phase II clinical trial of its drug candidate CVBT-141H for the treatment of severe coronary heart disease in the coming months. For more details please visit www.cvbt.com.

About CardioVascular BioTherapeutics
CVBT is a biopharmaceutical company developing drug candidates with FGF-1 as its active pharmaceutical ingredient (API) for diseases characterized by inadequate blood flow to a tissue or organ. The company has FDA-authorization for a Phase II trial to treat severe Coronary Heart Disease (CVBT-141H) and a Phase I trial to treat Peripheral Arterial Disease (CVBT-141C). A Phase Ib or Phase II trial to treat dermal wound healing in diabetics (CVBT-141B) is planned to begin in 2008.

Contact:
CardioVascular BioTherapeutics, Inc.
Allison Lipson, (702) 588-2072
alipson@cvbt.com

Source: CardioVascular BioTherapeutics, Inc.
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New Treatment for Heart Transplant Hopefuls An experimental treatment is giving desperately ill heart patients a new lease on life. By Lisa Collier Cool  - View Article HERE

About CardioVascular BioTherapeutics

The Company’s lead drug candidate successfully completed initial clinical trials in Germany during the 1990s, with no drug-related adverse events and a statistically significant increase in localized blood vessel growth (and perfusion) both in patients also receiving coronary by-pass procedures and in patients with severe coronary heat disease (CHD) receiving FGF-1, as the sole therapy. Enrollment and treatment has been completed in an FDA authorized Phase I study with CVBT-141A, administered via injection in severe CHD patients. The protocol design for the Phase II trial (CVBT-141H) has been approved by the FDA and is planned to initiate in 2008.

CardioVascular BioTherapeutics, Inc. is committed to conducting additional clinical trials to establish the positive effect of FGF-1141 aimed at improving the quality of life for those suffering from heart disease, stroke, diabetic wounds, or peripheral artery disease, and pledges to continue exploration for additional applications of FGF-1. 

Meeting a Significant Need

• 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
• Every 35 seconds someone will suffer a heart attack or strokea

>>>>>>>>>>>>>>>>>>Overview>>>>>>>>>>>>>>>>>>>>>Market Opportunities

 

CVBT is committed to exploring medical applications for our drugs which contain the active pharmaceutical ingredient of FGF-1. To achieve this goal, we conduct ongoing research and continually collaborate with internationally recognized researchers in the areas of angiogenesis and growth factors. We place a high priority on communicating information about our clinical trials to physicians, patients, investors, and other interested parties. CVBT has posted protocol information for its Phase II severe coronary heart disease (CHD) clinical trial on this website. For additional information regarding this trial as well as our other trials, you may also visit the National Institutes of Health's (NIH) Clinical Trials website at www.clinicaltrials.gov.

Clinical Foundation: Two clinical trials were conducted with CVBT-141A in the 1990s in Germany; the first with 40 patients of which, 20 were in the control group, and the second with 20 patients all of whom received treatment. These trials had no adverse events and met their clinical endpoints.

Unique Regenerative Approach: The Company’s focus is to treat diseases regeneratively by stimulating angiogenesis, vasculogenesis and neurogenesis locally with injectable and topical drug candidates containing the API, rather than attempting to repair blocked blood vessels or damaged tissue.

Patent Position: The Company has IP with 5 issued U.S. Patents, and 5 foreign patent applications related to U.S. patents. The Company continuously focuses on opportunities to extend the IP portfolio.
 

Development Programs Based On Early Clinical Success

The first clinical study with a formulation of CVBT-141A was conducted by Dr. Thomas Stegmann from 1995 to 1997 in Fulda, Germany.  CVBT-141A was injected directly into the wall of the heart of 20 patients with coronary artery disease. These patients were also receiving a coronary bypass procedure (CABG). A control group of 20 patients received CABG alone. The patients treated with CVBT-141A showed a significant increase in localized blood vessel growth at the site of the injection and, importantly, these vessels persisted when monitored at a three year follow-up examination.  The blood vessel growth was determined to be statistically significant over controls at both six months and three years following injection of CVBT-141A (p-value of < 0.005 at each time period). 

A second clinical study of 20 patients was performed from 1998 through 1999, where CVBT-141A injection was used as the sole therapy; there was no control group in this study for ethical reasons, as administration of the placebo would have required unnecessary surgery. The results of the second study demonstrated no adverse events from the growth factor injection and no adverse safety effects of the therapy.  Notably, 80% of patients showed a significant increase in tests that measure blood flow and 90% of patients had an improvement in their dominant clinical symptom, chest pain.  For two patients angina scores remained the same, but during stress exercise tests chest pain was either completely absent or began at much higher levels of exertion.

Protein vs Gene Therapy

Initial clinical success with CVBT-141A as a protein therapy in the 1990s is in stark contrast to problems encountered when attempting angiogenesis using gene therapy. Gene-based therapies may result in side effects due to the virus-mediated gene transfer, difficulties integrating the therapeutic DNA (gene) into the genome of target cells, unregulated and variable protein expression leading to angiogenesis at sites other than those targeted, and difficulty ensuring localized release and activity. Further, gene-based approaches may be limited by the inflammatory host response induced by the viral vectors and the transient nature of the intervention.
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Recent News From CVBT

Press Release Source: CardioVascular BioTherapeutics
Wednesday December 5, 12:00 pm ET

EL DORADO HILLS, Calif.--(BUSINESS WIRE)--Dutton Associates continues its coverage of CardioVascular BioTherapeutics (OTCBB:CVBT - News) maintaining a Speculative Buy rating and a $1.20 target price. The report by Dutton senior analyst Richard West, CFA is available at www.jmdutton.com as well as from First Call, Bloomberg, Zacks, Knobias, Reuters, and other leading financial portals.

There have been several events announced since our research report of April 5, 2007, which impact the current and future investment status, centering on CardioVascular BioTherapeutics’ (CardioVascular) progress of its drug candidates through the U.S. Food and Drug Administration (FDA) clinical trial process. In a November 28, 2007 Research Note, we reinstated our rating of Speculative Buy and assigned a 12-month price target of $1.20 per share for Cardio. Recently, CardioVascular announced the completion of its Phase I wound healing FDA clinical trial evaluating the safety and tolerability of its protein-based drug candidate CVBT-141B for dermal wound healing, formulated with human fibroblast growth factor -1 (FGF-1). CardioVascular is making positive progress with its ongoing FDA clinical trials for: severe coronary heart disease - surgical delivery and catheter, wound healing, and peripheral artery disease. In a recent question and answer session on a conference call, Cardio discussed the status of the $15.0 million PIPE that is currently on hold and reaffirmed that Cardio would not sell stock below $1.00 per share. Cardio also indicated that management and members of its board of directors are loaning the Company capital (at 6% interest) to allow the company to weather the current liquidity situation. Finally, they noted that the holder of a convertible note had completed its selling of the converted common stock that had been pressuring the stock down this past year.  MORE

Press Release Source: CardioVascular BioTherapeutics, Inc.
Thursday November 29, 8:00 am ET

LAS VEGAS--(BUSINESS WIRE)--CardioVascular BioTherapeutics, Inc. (OTCBB: CVBT - News) today announced that its investigational study to establish non-invasively the correlation of under-perfusion with disc degeneration has been accepted for presentation by Dr. Vance Gardner at the invitation-only World Forum for Spine Research meeting to be held Jan. 23-26, 2008 in Kyoto, Japan.

CVBT is conducting this investigational study in conjunction with the Orthopaedic Education and Research Institute of Southern California and the University of California, Irvine. Dr. Gardner is the lead investigator and has developed a Magnetic Resonance Imaging technique that images the feeding arteries and measures spinal blood flow into the region. Normal controls as well as patients with low back pain due to degenerative disc disease are being evaluated. MORE

CVBT Leadership

Dr. Stegmann is the cardiac surgeon who pioneered the procedure upon which CVBT was founded.   He is a member of the Faculty at the Hannover Medical School in Germany, and for 22 years held the position of Director of the Department for Thoracic and Cardiovascular Surgery at the Fulda Medical Center in Germany.  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.  He received his medical degree (summa cum laude) from Heidelberg University, Heidelberg, Germany.

Dan Montano brings a wide range of management experience to his roles, having served as CEO of 14 operating companies  including medical technology and biotechnology firms.  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.

Financial Highlights For CVBT

To Contact CVBT

CardioVascular BioTherapeutics, Inc.
1635 Village Center Circle
Suite 250
Las Vegas, NV 89134
 Phone: (702) 839-7220
investorrelations@cvbt.com

Investor Relations Contact:
Don Markley
Lippert/Heilshorn & Associates
Tel: 310-691-7100
Email: dmarkley@lhai.com

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