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 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.
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.
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.
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.
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.
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.
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?
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Editors
General Discussion on CVBT.OB
Is this a buy or a sell? ReplyEditors
Interactive Q&A: Daniel Montano, Chairman, President and CEO of CardioVascular BioTherapeutics Inc. (CVBT.OB) [view article]
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
Montano,
Chairman,
President
and CEO of C
ardioVascula
r
BioTherapeut
ics
Interactive Q&A: Daniel Montano, Chairman, President and CEO of CardioVascular BioTherapeutics Inc. (CVBT.OB) [view article]
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.Montano,
Chairman,
President
and CEO of C
ardioVascula
r
BioTherapeut
ics
Interactive Q&A: Daniel Montano, Chairman, President and CEO of CardioVascular BioTherapeutics Inc. (CVBT.OB) [view article]
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.Montano,
Chairman,
President
and CEO of C
ardioVascula
r
BioTherapeut
ics
Interactive Q&A: Daniel Montano, Chairman, President and CEO of CardioVascular BioTherapeutics Inc. (CVBT.OB) [view article]
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.
Montano,
Chairman,
President
and CEO of C
ardioVascula
r
BioTherapeut
ics
Interactive Q&A: Daniel Montano, Chairman, President and CEO of CardioVascular BioTherapeutics Inc. (CVBT.OB) [view article]
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.
1
Interactive Q&A: Daniel Montano, Chairman, President and CEO of CardioVascular BioTherapeutics Inc. (CVBT.OB) [view article]
It appears that the trial for Tropical Dermal Wound Healing and Peripheral Artery Disease has not started in 2007. What cause the delay?Editors
Interactive Q&A: Daniel Montano, Chairman, President and CEO of CardioVascular BioTherapeutics Inc. (CVBT.OB) [view article]
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
Interactive Q&A: Daniel Montano, Chairman, President and CEO of CardioVascular BioTherapeutics Inc. (CVBT.OB) [view article]
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
Interactive Q&A: Daniel Montano, Chairman, President and CEO of CardioVascular BioTherapeutics Inc. (CVBT.OB) [view article]
Dan,What is your present commercialization strategy?
--John
Montano,
Chairman,
President
and CEO of C
ardioVascula
r
BioTherapeut
ics
Interactive Q&A: Daniel Montano, Chairman, President and CEO of CardioVascular BioTherapeutics Inc. (CVBT.OB) [view article]
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
Montano,
Chairman,
President
and CEO of C
ardioVascula
r
BioTherapeut
ics
Interactive Q&A: Daniel Montano, Chairman, President and CEO of CardioVascular BioTherapeutics Inc. (CVBT.OB) [view article]
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
Interactive Q&A: Daniel Montano, Chairman, President and CEO of CardioVascular BioTherapeutics Inc. (CVBT.OB) [view article]
Dan: I saw that you raised money in May. Can you talk about your capital needs going forward?Interactive Q&A: Daniel Montano, Chairman, President and CEO of CardioVascular BioTherapeutics Inc. (CVBT.OB) [view article]
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