CARDIOVASCULAR BIOTHERAPEUTICS, INC. (OTCBB: CVBT)

Dear StockUpTicks Reader,

As many of our dedicated readers are well aware, we frequently publish as to our affinity for the biotech sector and the many opportunities within it.  It is clear that the throng of aging baby boomers heading toward the health care door will have an enormous impact on the biotech, pharma and healthcare sectors.  So, we’re always on the lookout for novel technologies within the aforementioned arenas.

We introduced one such company to you just about a year ago - CardioVascular BioTherapeutics Inc. (OTCBB: CVBT).  We have continued to bring you news and updates on this highly promising company and we felt a full update to their profile was in order given the outstanding progress CVBT has made. 

What strikes us most about CVBT is its particular niche.  Some of you are undoubtedly aware that 60 million people in the U.S. suffer from heart disease.  Without a doubt there is a tremendous need for a safer and lower-cost treatment for heart disease – and CVBT provides one.  Most briefly explained, CVBT has developed a protein therapy (not a gene therapy) that improves and increases the vascular tributaries providing blood flow to the heart, which in turn heals areas damaged by heart attack and stroke. 

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).  Having completed enrollment and treatment of its Phase I study, CVBT is designing and planning its Phase II clinical trials, which it expect to launch during this year.  Please take a moment to peruse today's updated profile below and be sure to keep an eye on CVBT.
 

About CardioVascular BioTherapeutics

The Company is developing injectable and topical formulations of its active pharmaceutical ingredient (API) to facilitate the growth of new blood vessels (neoangiogenesis) in the heart and other tissues and organs compromised by impaired blood supply (hypoxia, ischemia).  Formulations of the Company’s API contain Fibroblast Growth Factor 1 (FGF-1); a human protein manufactured using a proprietary technology.  FGF-1 stimulates the growth and proliferation of the three main cell types of blood vessels; endothelial cells, smooth muscles cells and pericytes.

CVBT-141A, 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 “Limited-Option” heart patients receiving CVBT-141A, as the sole therapy.  Enrollment and treatment has been completed in an FDA authorized Phase I study with CVBT-141A, administered via myocardial injection in “Limited-Option” heart patients. The protocol design for the planned Phase II trial is underway, with FDA input, and is planned to initiate in 2007.

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 stroke

>>>>>>>>>>>>>Clinical Trials Planned for 2007>>>>>>>>>>>Market Opportunities

 

The “CVBT-141A, for Limited-Option” heart patient - Phase II trial to begin in 2007  The FDA-authorized Phase I trial of CVBT-141B, for diabetic wound healing, began in 2006 and is expected to conclude in early 2007 followed by a planned Phase Ib or IIa trial The FDA authorized a Phase I clinical trial for peripheral artery disease (PAD), CVBT-141C, which the company plans to complete in 2007.  A Phase II trial could also begin in 2007

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.

Clinical Programs Summary

CVBT-141A: In March 2006, the Company completed enrollment and treatment of 21 patients at 6 U.S. sites in its dose-escalating CVBT-141A Phase I trial for “Limited-Option” heart patients. The twelve month follow-up visits for the last two patients will be completed in March 2007. To date there have been no reports of significant unexpected adverse effects attributable to the injections of CVBT-141A. Final safety data is being collected, and a Phase II protocol is being completed with input from the FDA. The Company expects to enter Phase II testing in 2007. 

“Limited-Option” heart patients are people whose physicians have informed them that no traditional medical treatment exists for their end-stage heart disease, often as a result of progressive, diffuse coronary heart disease, and frequently after previous CABG surgery, after heart transplantation or due to other medical conditions.

CVBT-141C: The FDA has authorized the initiation of a Phase I trial for CVBT-141C for the treatment of Peripheral Artery Disease (PAD), specifically for patients with intermittent claudication (cramping pain and weakness in the legs during walking). The trial is expected to begin in 2007; 24 patients will be enrolled, each of whom will be given three escalating doses of the drug. Magnetic Resonance Imaging (MRI) will be used to measure increased circulation.

Indication/Program	Research	Preclinical	Phase I	Phase II	Phase III
Limited-Option Heart  - CVBT-141A				Planned ‘07
Diabetic Wound Healing - CVBT-141B			In Progress	Planned ‘07
Peripheral Artery Disease - CVBT-141C			In Progress	Planned ‘07
Catheter Delivery of CVBT-141A		In Progress

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.
 

Near-Term Milestones

• Complete European stock listing on London Stock Exchange Alternative Investment Market (AIM) 
• Complete CVBT-141B Phase I wound healing trial; analyze results
• Initiate patient treatment in CVBT-141C Phase I PAD trial
• Obtain FDA authorization for CVBT-141A Phase II “Limited-Option” heart patient trial; begin trial
• Obtain FDA authorization to begin CVBT-141B Phase Ib or IIa trial in wound healing; complete trial
• Obtain FDA authorization to begin CVBT-141C Phase II trial in PAD; begin trial

Recent News From CVBT

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

LAS VEGAS--(BUSINESS WIRE)--CardioVascular BioTherapeutics, Inc. (OTCBB:CVBT - News) today announced that the U.S. Patent and Trademark Office allowed CVBT's patent application entitled, "Method of Producing Biologically Active Human Acidic Fibroblast Growth Factor and its Use in Promoting Angiogenesis." This patent describes the technology to produce human Acidic Fibroblast Growth Factor, also known as Fibroblast Growth Factor-1 (FGF-1), its delivery via direct injection into the heart muscle, and the therapeutic utility of this protein in the heart as an agent to stimulate new blood vessel growth, a process called angiogenesis.

"The technology covered by this patent involves the injection of our protein drug candidate directly into the damaged heart muscle of patients suffering from coronary artery disease," stated Thomas J. Stegmann, M.D., Chief Medical Officer and Co-President of CVBT. "As a cardiovascular surgeon, I believe that this may be the most effective means to increase blood flow into the heart muscle of patients afflicted with diffuse coronary artery disease. Several previous clinical trials by others where the therapeutic agent was administered into the coronary artery, or delivered as a gene therapy treatment, appear to have failed because they were either unsafe or did not meet their primary efficacy endpoints."

You may view the entire release and disclaimer here

Press Release Source: SmallCap Sentinel; CardioVascular BioTherapeutics, Inc.
Wednesday November 15, 6:00 am ET

IRVINE, Calif., Nov. 15, 2006 (PRIMEZONE) -- A comprehensive research report focusing on CardioVascular BioTherapeutics, Inc. (OTC BB:CVBT.OB - News) and the Biopharmaceutical industry has been published by Beacon Equity Research and is available free of charge to the general public.

The report will feature detailed information regarding CardioVascular BioTherapeutics, Inc. and address related companies including Genentech (NYSE:DNA - News), Pfizer (NYSE:PFE - News), and Schering-Plough Corp. (NYSE:SGP - News).

To view the report in its entirety, please visit: http://BeaconEquityResearch.com

You may view the entire release and disclaimer here

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

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