ENDV - FDA Recommends Endovasc Revise Phase III Plans for NRA and Simplify
Liprostin Phase III Trial; Study Revisions Could Mean a Solid Future for the
Company
MONTGOMERY, Texas, Nov 8, 2001 (BW HealthWire) -- Endovasc Ltd. Inc.
(OTCBB:ENDV)(Berlin:ED7) today announced very encouraging results of meetings
with the Food and Drug Administration (FDA) regarding Liprostin(TM) and Nicotine
Receptor Agonist (NRA). FDA agreed to the company's simplifying Liprostin(TM)'s
Phase III protocol for the treatment of critical limb ischemia (CLI) and to
proceed from NRA animal studies to Phase III clinical trials for treatment of
chronic coronary ischemia which provides the company opportunities to escalate
its timeline to market. Based on the results of these meetings, Endovasc is now
proceeding with development of Phase III protocol, bypassing Phase I/II for the
NRA product and revisions to its Phase III protocol for Liprostin(TM), which
includes revised end points and extended patient enrollment.
"We were extremely encouraged by these meetings," stated Dr. David Summers,
chairman and CEO. "In light of our FDA meetings, changes to the protocols for
both products are being initiated, which means that both Phase III trials could
be in full swing during the first quarter, 2002. As we progress, we will keep
everyone informed. This is great news to present at our annual meeting on
Friday, Nov. 9. We have two potential "home run" products that are now in the
final stage of regulatory approval. This is simply remarkable for a small
company such as ours."
The company stated that a revised Liprostin(TM) Phase III protocol will be
submitted to the FDA by the end of this month, allowing the first patient to be
treated sometime in early January 2002.
The company's other product, NRA-angiogenic agent, intra-coronary injection
protocol plan for chronic coronary ischemia, which calls for a single episode of
injections into the blood-deficient area of the heart, is designed to stimulate
growth of new blood vessels in the heart to relieve intractable anginal pain and
improve the patient quality of life. Results from the company's large animal
studies on dogs and pigs indicate that a single series of injections of the
nicotine receptor agonist, all done during a single hospital procedure could
stimulate a significant growth of new blood vessels. The company expects that
this new blood supply will provide relief from chronic chest pain and estimates
there are a minimum of 400,000 patients that could benefit from this new
procedure. The company will meet with the FDA prior to the formal submission of
the new Phase III protocol before the end of the year and anticipates Phase III
NRA clinical trials could start in the first quarter of 2002.
About the company:
Endovasc Ltd. Inc. is a biopharmaceutical/biotech company pioneering liposomal
drug delivery technology. In addition to Liprostin(TM) and NRA, the company is
developing a stent-coating technology that has shown encouraging results in
recently concluded pig studies and, a biodegradable, resorbable stent, all
covered by patents, licenses and trade secrets for competing in a multi-billion
dollar market.
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 Ltd. Inc., contact:
CONTACT: Endovasc Ltd. Inc., Montgomery
New Business Development and Investor Relations:
John (Jack) T. Sorbi Jr., 936/448-2222
Jack@endovasc.com
or
Clinical Research:
Barbara J. Richardson, 936/448-2222
bjr@endovasc.com
Fax: 936/582-2250
Web: www.endovasc.com |
