On the heels of FDA authorization to initiate Phase II clinical trials for severe coronary heart disease patients, CardioVascular BioTherapeutics, Inc. (OTCBB: CVBT) today announced that findings from its initial clinical protocol for its protein drug candidate will be presented by Dr. Lynne Wagoner at the American Heart Association's Scientific Session to be held Nov. 4-7 in Orlando, Florida.
Results from the Phase I trial using CVBT's human fibroblast growth factor 1 (FGF-1) indicated that the drug candidate was a safe and biologically-active treatment for patients with severe heart disease. The study was conducted at medical centers across the U.S. and confirmed results from previous human studies that FGF-1 is a safe and biologically active protein when injected directly into the heart muscle. No significant, unexpected adverse events attributable to the drug were reported in any of the patients treated, and preliminary indications of bioactivity were noted, even though the trial was not designed to demonstrate efficacy.
CVBT is focusing on developing additional formulations of FGF-1, a recombinant protein that stimulates new blood vessel growth, a process known as angiogenesis, to serve as a new and cost effective approach for a large number of cardiovascular disease indications.
"Patients who participated in the trial showed a decrease in frequency of chest pain or discomfort and an overall improvement in anginal stability and capacity for exertion," said Dr. Wagoner, Consultant, Greater Cincinnati Cardiovascular Consultants and principal investigator for the Phase I clinical trial. "We are in dire need of an effective and viable treatment for cardiovascular disease patients with no other options. Angiogenesis represents a less invasive means of increasing blood flow to the heart."
Dr. Wagoner will present her study findings during a poster session at 9 a.m. on November 5th at the AHA Scientific Session, the world's largest annual meeting for researchers and healthcare professionals treating both cardiovascular disease and stroke patients.
Dr. Jack Jacobs, CVBT's Chief Scientific Officer commented, "We are very pleased that Dr. Wagoner will be able to present our promising Phase I results at this year's AHA meeting. She was the top-enrolling investigator in our Phase I trial and we look forward to her participation in our worldwide Phase II trial, which is planned for 30 sites. The company is confidant that in the Phase II trial we will confirm and extend the excellent safety and activity profile we have seen with FGF-1 in three previous clinical studies, where this angiogenic protein was injected into the hearts of coronary heart disease patients. We are also excited that in the Phase II trial we will use a less invasive, catheter drug delivery system, distributed by Biologics Delivery Systems Group, Cordis Corporation, who has worked closely with CVBT in clinical site selection and the Phase II clinical protocol design."
About CardioVascular BioTherapeutics
CVBT is a biopharmaceutical company developing drug candidates with human FGF-1 as their active pharmaceutical ingredient (API) for diseases characterized by inadequate blood flow to a tissue or organ. The company has three clinical trials underway with drug candidates to treat the following medical indications: severe Coronary Heart Disease (CVBT-141H), dermal wound healing in diabetic and venous stasis ulcers (CVBT-141B), and Peripheral Arterial Disease (CVBT-141C).
This news release contains forward-looking statements that involve risks and uncertainties. Actual results and outcomes may differ materially from those discussed or anticipated. For example, statements regarding expectations for new research, progress with clinical trials or future business initiatives are forward looking statements. Factors that might affect actual outcomes include, but are not limited to, FDA approval of CVBT drug candidates, market acceptance of CVBT products by customers, new developments in the industry, future revenues, future expenses, future margins, cash usage and financial performance. For a more detailed discussion of these and associated risks, see the company's most recent documents filed with the Securities and Exchange Commission.
Showing posts with label CardioVascular BioTherapeutics. Show all posts
Showing posts with label CardioVascular BioTherapeutics. Show all posts
Wednesday, November 7, 2007
Sunday, November 4, 2007
Plant Which Manufactures CardioVascular BioTherapeutics' Drug Candidates Receives California State License
CardioVascular BioTherapeutics, Inc. (OTCBB: CVBT) today announced that the new manufacturing facility in San Diego where its protein-based drug candidate, human fibroblast growth factor-1 (FGF-1), is manufactured has received a California Food and Drug Board license to manufacture pharmaceuticals for clinical and commercial use. The plant is operated by CVBT's manufacturing partner, Phage Biotechnology Corporation (Phage). Phage has produced all of the FGF-1 that CVBT has utilized in its pre-clinical and clinical development programs.
To obtain a California State Manufacturing License, Phage, with CVBT's support, went through an intensive on-site inspection of the new manufacturing plant in San Diego. The clinical lot of FGF-1 which will be utilized in CVBT's upcoming Phase II trial in no-option heart patients was the focus of the inspection. Over 400 documents relating to the GMP (good manufacturing practices) production of the FGF-1 lot were inspected, as well as the plant's manufacturing equipment, and its air and water systems.
Dr. Jack Jacobs, CVBT's Chief Operating and Scientific Officer, commented "We are very pleased that our clinical lots of FGF-1 are being produced to GMP standards. California is one of only three states in the U.S. that requires manufacturing facilities to be inspected and licensed for products used in clinical trials, which occurs well before a drug is approved for sale. The California State inspection is similar to the FDA inspection required for drug registration and sale."
Dr. Jacobs also noted that the recent fires in the San Diego region did not adversely affect the manufacturing plant or CVBT's R&D lab situated adjacent to the manufacturing plant. Neither facility suffered damage and both are fully operational.
About CardioVascular BioTherapeutics
CVBT is a biopharmaceutical company developing drug candidates with FGF-1 as their active pharmaceutical ingredient (API) for diseases characterized by inadequate blood flow to a tissue or organ. The company has FDA-authorized clinical trials in three distinct medical indications with its drug candidates including: an ongoing Phase II trial in severe Coronary Heart Disease (CVBT-141H); a Phase Ib or Phase II dermal wound healing in diabetics (CVBT-141B) estimated to begin in Q1, 2008; and a Phase I study in Peripheral Arterial Disease (CVBT-141C).
This news release contains forward-looking statements that involve risks and uncertainties. Actual results and outcomes may differ materially from those discussed or anticipated. For example, statements regarding expectations for new research, progress with clinical trials or future business initiatives are forward looking statements. Factors that might affect actual outcomes include, but are not limited to, FDA approval of CVBT drug candidates, market acceptance of CVBT products by customers, new developments in the industry, future revenues, future expenses, future margins, cash usage and financial performance. For a more detailed discussion of these and associated risks, see the company's most recent documents filed with the Securities and Exchange Commission.
To obtain a California State Manufacturing License, Phage, with CVBT's support, went through an intensive on-site inspection of the new manufacturing plant in San Diego. The clinical lot of FGF-1 which will be utilized in CVBT's upcoming Phase II trial in no-option heart patients was the focus of the inspection. Over 400 documents relating to the GMP (good manufacturing practices) production of the FGF-1 lot were inspected, as well as the plant's manufacturing equipment, and its air and water systems.
Dr. Jack Jacobs, CVBT's Chief Operating and Scientific Officer, commented "We are very pleased that our clinical lots of FGF-1 are being produced to GMP standards. California is one of only three states in the U.S. that requires manufacturing facilities to be inspected and licensed for products used in clinical trials, which occurs well before a drug is approved for sale. The California State inspection is similar to the FDA inspection required for drug registration and sale."
Dr. Jacobs also noted that the recent fires in the San Diego region did not adversely affect the manufacturing plant or CVBT's R&D lab situated adjacent to the manufacturing plant. Neither facility suffered damage and both are fully operational.
About CardioVascular BioTherapeutics
CVBT is a biopharmaceutical company developing drug candidates with FGF-1 as their active pharmaceutical ingredient (API) for diseases characterized by inadequate blood flow to a tissue or organ. The company has FDA-authorized clinical trials in three distinct medical indications with its drug candidates including: an ongoing Phase II trial in severe Coronary Heart Disease (CVBT-141H); a Phase Ib or Phase II dermal wound healing in diabetics (CVBT-141B) estimated to begin in Q1, 2008; and a Phase I study in Peripheral Arterial Disease (CVBT-141C).
This news release contains forward-looking statements that involve risks and uncertainties. Actual results and outcomes may differ materially from those discussed or anticipated. For example, statements regarding expectations for new research, progress with clinical trials or future business initiatives are forward looking statements. Factors that might affect actual outcomes include, but are not limited to, FDA approval of CVBT drug candidates, market acceptance of CVBT products by customers, new developments in the industry, future revenues, future expenses, future margins, cash usage and financial performance. For a more detailed discussion of these and associated risks, see the company's most recent documents filed with the Securities and Exchange Commission.
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