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( BW)(NV-CARDIOVASCULAR-BIO)(CVBT) Plant Which Manufactures
CardioVascular BioTherapeutics' Drug Candidates Receives California
State License
Business Editors/Health Editors
LAS VEGAS--(BUSINESS WIRE)--Nov. 1, 2007--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.
CONTACT: CardioVascular BioTherapeutics, Inc.
Investor Relations, 702-839-7220
investorrelations@cvbt.com
or
For CardioVascular BioTherapeutics, Inc.
Schwartz Communications
Erin Walsh, 781-684-6532
cvbt@schwartz-pr.com
KEYWORD: NEVADA INTERNATIONAL ASIA PACIFIC EUROPE
INDUSTRY KEYWORD: PHARMACEUTICAL MEDICAL DEVICES BIOTECHNOLOGY
PRODUCT
SOURCE: CardioVascular BioTherapeutics, Inc.
Copyright Business Wire 2007
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