Interactive Q&A: Daniel Montano, Chairman, President and CEO of CardioVascular BioTherapeutics Inc. (CVBT.OB)

This is the latest in Seeking Alpha's series of interviews with leading companies of interest to our readers. Ours are interviews with a twist: the respondent has agreed to answer questions and respond to comments not from a single interviewer, but rather from our community of readers and contributors.

This interactive Q&A is with Daniel C. Montano, Chairman, President and CEO of CardioVascular BioTherapeutics (CVBT.OB). CardioVascular BioTherapeutics, Inc. is a biopharmaceutical company developing surgical and topical formulations of its lead compound, Fibroblast Growth Factor 1 (FGF-1141) which has multiple applications for the regenerative treatment of cardiovascular disease. FGF-1141 is a human protein manufactured using a proprietary technology that stimulates angiogenesis, vasculogenesis, and neurogenesis.

CVBT is continuing to advance its technical platform through clinical trials to specifically treat impaired blood supply and damaged tissue associated with: (a) Severe Coronary Heart Disease; (b) Dermal Wounds; (c) Peripheral Arterial Disease; and (d) Disc Ischemia.

Clinical Trial Summary:

Severe Coronary Heart Disease [CHD]: In July 2007, the FDA authorized a Phase II trial for severe CHD which incorporates injection catheter delivery of FGF-1. CVBT has completed the Phase I trial which was carried out at six medical centers in the U.S., and verified the safety and provided evidence of the biological activity of FGF-1 administration to the heart. No significant, unexpected adverse events were apparent in any of the patients treated, and preliminary indications of bioactivity were noted.

Topical Dermal Wound Healing: The FDA authorized a Phase I trial for wound healing of dermal ulcers, which began in 2006, and is expected to conclude in 2007. Three patients have been treated as of December 31, 2006 in a two-site FDA authorized Phase I clinical trial for a total of eight patients with diabetic foot ulcers. Based on the outcome of the Phase I trial and discussions with the FDA, the Company plans to begin further clinical trial in 2007.

Peripheral Artery Disease: The FDA has authorized a Phase I clinical trial for Peripheral Artery Disease [PAD]. The FDA has authorized the initiation of a Phase I trial for the treatment of PAD), specifically for patients with intermittent claudication. 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.

Clinical Proof-of-Concept Studies:

Disc Ischemia: Investigational study underway with the Orthopedic Education and Research Institute of Southern California to establish non-invasively the correlation of under-perfusion with disc degeneration.

(See CVBT's corporate fact sheet, corporate web site, SEC docs and July 2007 Business Week article entitled "The Search for Angiogenesis Therapy" for more background. CVBT's upcoming earnings call will take place on July 19th at 11AM. You can access the webcast here.)

CardioVascular BioTherapeutics, Inc. has sponsored this interview (for sponsor information contact us here), which works like this:

• Dan briefly introduces himself below.
• Readers and contributors can immediately start to post questions and remarks using the comment box below (Note: you need to sign up for free registration and be logged in to do so).
• Seeking Alpha editors will not filter or edit the questions and comments from readers, except to delete profane or hostile language.
• Dan will respond to the questions and remarks beginning Monday, July 16th. Readers can track his answers and respond to them during that period.

Yahoo Finance readers may join the Q&A by following this link.

Over to Dan:

• • •

My name is Dan Montano and I'm Chairman, President and CEO of CardioVascular BioTherapeutics, Inc. (CVBT.OB). Thanks to Seeking Alpha for providing this opportunity to interact with investors.

Please leave your questions by using the comment box below.

Thank you!
-- Dan

This Q&A represents the opinion of CardioVascular BioTherapeutics, Inc. management and is not intended to be a forecast of future events, a guarantee of future results nor investment advice. Except for the statements of historical fact, information presented herein may constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of the company to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Such factors include general economic and business conditions, the ability to fund operations, the ability to forge partnerships and other factors over which CardioVascular BioTherapeutics, Inc. has little or no control. CardioVascular BioTherapeutics, Inc. assumes no obligation to publicly update or revise any forward-looking statements provided in this Q&A, or to correct any erroneous information presented in any investor questions herein.

Comments

[David Zhang]

Dan,

Thanks for conducting this interview.

Can you comment on the Business Week article's conclusion that "the focus on protein could give CVBT an advantage"? Do you see that as your competitive advantage relative to others in your space?

Thanks,
David

[Daniel C. Montano, Chairman, President and CEO of CardioVascular BioTherapeutics]

Dear David:

Thank you for your question about the artcile in Business Week On-Line, Friday, July 6; "The Search for Angiogenesis Therapy," which discussed CardioVascular BioTherapeutics. Inc (CVBT). The answer is "Yes", I believe CVBT has an advantage in the development of a medical angiogenesis therapy. At the CVBT web-site (cvbt.com) you can read some papers on why we believe our protein is the correct drug to delivery medical results. Please read the past clinical trial data on the web-site, and I believe you can learn of our many years of interesting medical results. These years of successful medical results is why I believe we have an advantage over all others.

Dan Montano, CEO CVBT

[Joe Mama]

Dan: I saw that you raised money in May. Can you talk about your capital needs going forward?

[Daniel C. Montano, Chairman, President and CEO of CardioVascular BioTherapeutics]

Dear Joe:

CVBT believe's it has sufficent funds to advance the company's clinical trials into next year. We presently anticapate with positive results from our clinical trials, we will seek to rasie additional funds to fund our Phase III trial in the heart and other trials.

Dan Montano, CEO

[John]

Dan,
What is your present commercialization strategy?
--John

[Daniel C. Montano, Chairman, President and CEO of CardioVascular BioTherapeutics]

CVBT believes that the most important step in our commercialization strategy is to prove that our drug can grow new blood vessels in the heart, legs and other hypoxic tissues..

We believe the lack of blood flow to a tissue or organ is the largest un-met medical need in the developed world. More than 70 million people in the United States are suffering from cardiovascular diseases. We believe the marketplace opportunity for our drug could be measured in billions of dollars per year. In addition to Dr. Stegmann’s prior scientific & clinical work in Germany, which I personal believe is a proof of our concept; CVBT must obtain USA FDA and European Medical Agency approvals to sell our drug. If the Phase II heart trial we have just been cleared to advance upon, is successful, I believe we have many avenues available to CVBT to commercialize our drug. Those avenues would range from CVBT going alone to various kinds of partnering with larger Pharmaceutical companies. We will have greater clarity on our exact strategy after we have seen the data from this Phase II clinical heart trial.

[Ian]

Dan,

Thanks for your time.

Two questions:

Where are you in the patent process?
Can you discuss leading drug candidates at CVBT?

All the best,
Ian

[Daniel C. Montano, Chairman, President and CEO of CardioVascular BioTherapeutics]

On Patents, CVBT has been issued a series of different patents. I believe the two most important our patents are:
(1) The USA patent which addresses the injection of our drug (the angiogenic protein) into the human heart. That patent was issued & allowed by the US patent Office in 2007. Since we believe the only way the drug works is in direct contact with the up-regulated hypoxic tissue, therefore this patent, we believe is extremely important, since we believe only by injecting the drug into the muscle of the heart it can work properly and effectively.
(2) The world wide patent to a biomanufacturing process (the Phage Process) which we believe is very strong. We believe because this biomanufacturing process is so unique, that any potential competitor attempting to utilize the different Plasmid method of biomanufacturing would have to treat their drug as a completely new drug and undertake all of the drug approval processes. Since it has taken us 8 years to get this far, we believe any potential competitor would also take at least 8 to 10 years to get regulatory approval. We believe if we are the only drug which can treat the largest unmet medical need in the world for 8 to 10 years that, that is good.

Please, also go to our web site cvbt.com where there is a list of our patents

On drug candidates:

Please visit our web site cvbt.com as there is much greater detail on our leading drug candidates. CVBT is focused upon three drug candidates for treatment of:

Coronary Heart Disease. This is the number one cause of death in the United States and Europe. This is the area where we have just obtained our Phase II USA FDA clearance. We believe this is the most important area.

Wound Healing Disorders. Many wounds, especially on the legs and in diabetics, are unable to heal because of lack of blood flow and chronic hypoxia. We believe this is a major medical need, and we are now in the final stages of completing our Phase I wound healing trial. We believe this is a major drug candidate.

Peripheral Artery Disease (PAD) This is a major disease when the arteries in the legs become blocked. Reports claim about 8 million Americans suffer from this disease. We are preparing to start our Phase I trial to test for safety.

These are the three main drug candidates.

[SeekingAlpha Editors]

Dan,

I notice that the Phase II protocol is using a catheter versus the previous injection method. What's the reason behind the change?

Regards,
Saul

[Daniel C. Montano, Chairman, President and CEO of CardioVascular BioTherapeutics]

Dr. Stegmann and our medical management team have felt for years that the best way to delivery our drug is via the least invasive method for the patient. We have debated and pondered this for many years. After our successful Phase I, clinical heart trial was completed, our team started to prepare the Phase II. With their desire for catheter delivery and guidance from other scientists, it was decided now was the time to make this change. With the support and guidance of the Cordis Company ( a Johnson and Johnson company), we were able to develop a Protocol which the USA FDA has now allowed. So we are very happy. We believe this change allows us to recruit patents quicker, lower the cost of the treatment, make the treatment easier for the patents, doctors and provides for a control group in this trial. We also believe that if the drug is approved the best method to deliver the drug is via a catheter and so we made this move also in anticipation of the commercialization of our drug and the therapy.

[albertcheung1]

It appears that the trial for Tropical Dermal Wound Healing and Peripheral Artery Disease has not started in 2007. What cause the delay?

[Daniel C. Montano, Chairman, President and CEO of CardioVascular BioTherapeutics]

The tropical Phase I Wound Healing trial is in progress and I believe should completed soon. I believe we should be able to start the Phase II on wound healing this year. As regards the PAD trial, we are fine tuning our imaging and measurement methods. CVBT has taken the business position, since we started the company, that since from Dr. Stegmann’s original work, we believe that our drug can grow blood vessels and therefore address the largest unmet medical need in the developed world; that we should always move very cautiously and deliberately towards our objective of getting the drug approved. That to do anything in haste that could challenge what we believe works is not good business. The PAD trial we believe is very important to our company, and we want to be able to prove that we succeeded in our objectives. We have gone to great lengths to be able to measure and image what we believe we need to demonstrate that point. We have clearance to start from the USA FDA; we however are fine turning some points to enhance what we believe is our odds to succeed in proving our point in a PAD trial.

[SeekingAlpha Editors]

This Seeking Alpha interactive Q & A is now closed for further questions. Thank you very much to Daniel Montano, and to all of our readers who participated.

~ The Seeking Alpha Team