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.
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