GNBT Generex Biotechnology Corporation Receives Approval of U.S. IND for Buccal
Morphine Follows Recent Canadian IND Approval Clinical Trials Expected to
Commence in Upcoming Months
TORONTO, May 03, 2002 (Canada NewsWire via COMTEX) -- Generex Biotechnology
Corporation (Nasdaq: GNBT), a leader in the area of buccal drug delivery, today
announced that the U.S. Food and Drug Administration (FDA) has approved an
Investigational New Drug (IND) application for human clinical trials of buccal
morphine for the treatment of pain. The U.S. IND approval follows on the earlier
approval of a Canadian IND and the completion of a successful proof of concept
study of morphine delivered systemically through the buccal cavity. The company
expects to be in a position to commence clinical trials in the upcoming months.
Generex is pursuing the development of buccal morphine through the company's
business venture with Elan Corporation, plc. ("Elan"). Earlier this year,
Generex and Elan formally expanded their business venture to include buccal
delivery of morphine for the management of pain and selected buccal morphine as
the initial product for development under the venture.
"With this approval in hand, together with our prior Canadian IND approval, we
now can move forward now with clinical development activities," said Anna
Gluskin, President and CEO of Generex. "We look forward to working with Elan to
move the product through clinical trials as quickly and efficiently as
possible."
Ivan Lieberburg, Ph.D., M.D., Elan's Chief Scientific and Medical Officer stated
that, "We are very pleased that that US and Canadian IND approvals have been
obtained. We are optimistic that the development of buccal morphine through our
business venture with Generex can provide a meaningful opportunity for both of
our companies to participate in the sizeable prescription market for treatment
of pain."
Generex is engaged in the research and development of drug delivery systems and
technology. To date, it has focused on developing a platform technology for the
buccal delivery of large molecule drugs that, historically, have been
administered only by injection. The first application for this proprietary
technology is an insulin formulation that is administered as a fine spray into
the oral cavity. In September 2000, Generex entered into an agreement with Eli
Lilly and Company to develop this product. Lilly also has the option to develop
a number of additional products based on the success of the insulin product. In
January 2001, Generex formed a business venture with Elan to pursue the
application of certain proprietary drug delivery technologies of Generex and
Elan to certain pharmaceutical products. In January 2002, Generex and Elan
formally expanded the business venture to include buccal delivery of morphine
for the management of pain and selected buccal morphine as the initial product
for development under the venture.
Generex's buccal delivery technology has application to a large number of large
molecule drugs in addition to insulin and morphine. Fentanyl and heparin are
among the compounds that are candidates for product development.
This release and oral statements made from time to time by Generex
representatives concerning the same subject matter may contain "forward- looking
statements" within the meaning of the Private Securities Litigation Reform Act
of 1995. These statements can be identified by introductory words such as
"expects," "plans," "intends," "believes," "will," "estimates," "forecasts,"
"projects" or words of similar meaning, and by the fact that they do not relate
strictly to historical or current facts. Forward-looking statements frequently
are used in discussing potential product applications, potential collaborations,
product development activities, clinical studies, regulatory submissions and
approvals, and similar operating matters. Many factors may cause actual results
to differ from forward-looking statements, including inaccurate assumptions and
a broad variety of risks and uncertainties, some of which are known and others
of which are not. Known risks and uncertainties include those identified from
time to time in the reports filed by Generex with the Securities and Exchange
Commission, which should be considered together with any forward-looking
statement. No forward- looking statement is a guarantee of future results or
events, and one should avoid placing undue reliance on such statements. Generex
claims the protection of the safe harbor for forward-looking statements that is
contained in the Private Securities Litigation Reform Act.
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VIEW ADDITIONAL COMPANY-SPECIFIC INFORMATION:
newswire.ca
CONTACT: For further information: Paul Gambin of Time Release Corpora
ion,
1-800-391-6755, or fax, +1-416-364-8782, info(at)generex.com
or Jeffrey Volk
of Wolfe Axelrod Weinberger Assoc. LLC, +1-212-370-4500, or
ax,
+1-212-370-4505, jeff(at)wolfeaxelrod.com
URL: Web site: generex.com
News release via Canada NewsWire, Toronto 416-863-9350
Copyright (C) 2002 CNW, All rights reserved
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