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 (OTC:CVBT). 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. (OTC:CVBT). Thanks to Seeking Alpha for providing this opportunity to interact with investors.
Please leave your questions by using the comment box below.
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.