Attached files
| file | filename |
|---|---|
| 8-K - CardioVascular BioTherapeutics, Inc. | v204271_8k.htm |
Las Vegas, Nevada November 30,
2010—CardioVascular BioTherapeutics Inc. (trading symbol: CVBT.PK) today
announced the successful closing of an exclusive licensing agreement with an
affiliate of Merck & Co., Inc., for clinical and scientific data
regarding the therapeutic use of human fibroblast growth factor-1 (FGF-1) for
the treatment of diabetic wounds, including Phase IIa and IIb
data. CVBT intends to use the data, in conjunction with CVBT’s own
data, to apply to the FDA to advance its FGF-1 diabetic wound healing drug
candidate, CVBT-141B, to a pivotal Phase III trial, which, if approved by the
FDA, is anticipated to commence in 2011. Further, given the major
unmet medical need to heal diabetic patients’ open wounds, which are at great
risk of infection and which once infected often lead to limb amputations, CVBT
will be applying to the FDA for “Fast Track Development Program” status for
CVBT-141B.
CVBT’s
CEO, Daniel C. Montano, stated that “the Phase II clinical data, in conjunction
with additional unpublished pre-clinical data CVBT obtained in the licensing
agreement, clearly support our belief that CVBT-141B is a promising
wound-healing drug candidate, both in efficacy and safety. While CVBT
is presently focused on seeking accelerated approval of CVBT-141B for diabetic
wounds, CVBT is also planning to expand the use of this drug candidate to other
wound healing indications including venous stasis ulcers, surgical wounds, and
burns. Advanced wound management products, those used in the clinical
management of wounds (not OTC), represents an estimated $5 billion global market
opportunity that is predicted to triple in the next ten years. This
is a large and growing medical marketplace opportunity for CVBT, which may at
the same time save many lives and lessen the suffering of millions of diabetic
patients.”
About
CardioVascular BioTherapeutics
CVBT is a
biopharmaceutical company developing drug candidates with FGF-1 as its active
pharmaceutical ingredient (API) for diseases characterized by inadequate blood
flow to a tissue or organ. The company has FDA-authorization for a Phase II
trial to treat severe Coronary Heart Disease (CVBT-141H) and a Phase I trial to
treat Peripheral Arterial Disease (CVBT-141C). A Phase III trial to treat dermal
wound healing in diabetics (CVBT-141B) is planned to begin in 2011, pending FDA
approval.
# #
#
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.
# #
#
SOURCE:
CardioVascular BioTherapeutics, Inc.
Media Contact:
Allison
Caplan
CardioVascular
BioTherapeutics, Inc.
(702)
839-7200
acaplan@cvbt.com