ENDV Endovasc Completes 30-Day FDA Comment Period With 'No Comments' to Its IND
Filing
MONTGOMERY, Texas, May 14, 2002 /PRNewswire-FirstCall via COMTEX/ -- Endovasc
Ltd., Inc. (OTC Bulletin Board: ENDV; Berlin: ED7) today announced that its
Initial New Drug (IND) application submitted to FDA on April 11, 2002 completed
its required "30-day hold period" without further comment and was free to
commence its human clinical trials.
"It has been a tough and ambitious undertaking," said Endovasc Chairman Dr.
David Summers. "When we predicted this schedule back in 1999, we got a lot of
flack about being overly ambitious and optimistic. But due to the tremendous
effort of the entire regulatory team, we made it to Phase III with two approved
indications in record time!"
The Company said that FDA had given clinical trial approval for two major
diseases related to peripheral occlusive artery disease (POAD), critical limb
ischemia and chronic severe claudication. According to Company estimates, the
annual potential market is over $1 billion per year.
The Company has encapsulated Prostaglandin E-1 (PGE-1), a natural occurring
vasodilator, platelet aggregation antagonist and inhibitor of smooth muscle cell
migration, within germ-size microspheres made from the same fatty acids that
make up the body's own cells. The microspheres are called liposomes and have the
effect of stabilizing PGE-1 which when used in its raw form has several
undesirable side effects. Liposome eliminates or greatly reduces the side
effects, said the Company.
Endovasc Ltd. Inc. is a biotechnology company focused in the area of
cardiovascular disease, pioneering drug delivery technology designed to deliver
and release drugs to their intended targets in an efficient and controlled
manner. In addition to Liprostin(TM), the Company's products and processes
include: ANGIOGENIX(TM) (Nicotine Receptor Agonist), PROSTENT(TM) stent-coating
technology, and a biodegradable resorbable stent prosthesis.
The foregoing statements are made under the "Safe Harbor" Private Securities
Litigation Reform Act of 1995 and may contain forward-looking statements that
involve risks and uncertainties that may not be evident at the time of this
release. For more information about Endovasc, please visit www.endovasc.com .
(Investor questions and requests for materials can be submitted online.)
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SOURCE Endovasc Ltd., Inc.
CONTACT: Investor Relations, Endovasc Ltd., Inc., +1-936-448-2222,
or fax, +1-936-582-2250
URL: endovasc.com
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KEYWORD: Texas
INDUSTRY KEYWORD: BIO
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SUBJECT CODE: OTC
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