Avantogen Receives Milestone Payment from Endocyte for GPI Vaccine Adjuvant; Company Also Receives European Patent and Commences
15 June 2005 - 10:00PM
Business Wire
Avantogen, Ltd. (ASX:ACU), formerly Australian Cancer Technology,
today announced that Endocyte, Inc. will pay its first milestone
payment to the Company for Avantogen's successful submission of a
Drug Master File (DMF) to the U.S. Food and Drug Administration
(FDA) for its proprietary vaccine adjuvant GPI-0100. Avantogen
announced the submission of the DMF on April 7, 2005 in Australia.
Endocyte is Avantogen's partner and licensee for the use of
GPI-0100 in an immunotherapy for kidney cancer. Endocyte is
currently conducting a multi-center, open-label,
baseline-controlled, dose-ranging Phase I clinical study of an
investigational targeted immunotherapy using GPI-0100. The study is
designed to evaluate the safety and pharmacokinetics of the
immunotherapy regimen. Endocyte's novel targeted immunotherapy is
comprised of GPI-0100 adjuvant and a folate-conjugated molecule
(EC17) that targets folate receptor positive tumor cells to
potentially enhance tumor cell removal by cytokine stimulated
immune cells. The over-expression of the folate receptor occurs in
a number of malignancies, including kidney and ovarian cancers.
"This is the first milestone payment that we've received for
GPI-0100, and it validates our commercialization strategy for this
exceptional adjuvant," said Leonard Firestone, MD, CEO of
Avantogen. "We expect additional milestone payments from other
licensees, including Pfizer Animal Health Division, in the near
future. We anticipate that other companies will soon adopt GPI-0100
as their preferred vaccine adjuvant." More GPI Adjuvant Progress
This key milestone follows the granting of European patent number
0996451 entitled "Triterpene Saponin Analogs having Adjuvant and
Immunostimulatory Activity". The patent provides protection around
the Company's immune-enhancing adjuvant GPI-0100 and its use as a
component in vaccines and the initiation of preclinical trials for
the use of GPI-0100 in a potential vaccine to the Herpes Simplex
Virus (HSV-2) in European Union countries. Additionally, Avantogen
recently announced that, together with the University of Alabama at
Birmingham (UAB), the Company has commenced preclinical studies
using GPI-0100 as an adjuvant to increase the immune response to a
new vaccine designed to reduce the recurrence and shorten the
duration of herpetic lesions caused by the Herpes Simplex Virus
(HSV-2). The research will be conducted at UAB under the direction
of Earl R. Kern, Ph.D., Research Professor at UAB's Department of
Pediatrics and a recognized expert in the area of Herpes viruses.
Adjuvants boost the physiologic response to a foreign substance by
stimulating the immune system. GPI-0100, which Avantogen acquired
from Galenica in 2004, is a modified, semi-synthetic saponin, a
naturally occurring plant detergent or surfactant. The saponin upon
which GPI-0100 is based occurs in the bark of a South American
tree. GPI-0100 has been shown to stimulate both the antibody and
cellular components of the immune system, and modifications made to
the molecule increase its stability and safety profile versus
naturally occurring saponins. About Avantogen Avantogen (formerly
Australian Cancer Technology) is an international biotechnology
company developing a broad oncology-related product portfolio.
Avantogen is developing RP101, an exceptionally promising
pancreatic cancer drug currently in Phase II clinical studies,
through a joint venture with Bioaccelerate of New York. Avantogen's
Pentrys(TM) anti-cancer vaccine is undergoing phase IIb clinical
trials in prostate cancer patients, and the Company is advancing a
family of immune-enhancing adjuvants which has been in three Phase
I cancer trials in the United States. The company has also marketed
Revisys(TM), a branded line of medical nutritionals specifically
developed to address special nutritional needs, such as those
following cancer treatments. Avantogen is traded on the Australian
Stock Exchange (ASX) under the symbol ACU. The Company has
established a Level 1 ADR stock program in the U.S. trading under
the symbol AUCJY and also is listed on the Xetra exchange, the
electronic trading system of the Frankfurt Stock Exchange, trading
under the symbol CBS. About Endocyte Endocyte is an innovative
biotechnology company developing a new generation of
receptor-targeted therapeutics or "smart drugs" for the treatment
of cancer and autoimmune diseases. Current non-targeted drugs are
usually toxic to normal healthy cells causing side effects, some of
which can be serious and/or fatal. These side effects can lead to
suboptimal dosing in order to minimize toxicities. The company's
initial development focus is on a receptor for the vitamin folic
acid, which is often over-expressed in cancer cells. Animal studies
have shown that drugs targeted with folic acid have less toxicity,
allowing for more frequent dosing and improved efficacy. Endocyte
currently has two compounds in clinical trials -- EC20, a targeted
diagnostic agent that has been evaluated in phase 2 studies and
EC17, a targeted immunotherapy that is currently being evaluated in
phase 1 studies. Its third targeted drug, EC145, will begin Phase I
testing early next year. Endocyte is committed to building value by
building a rich product pipeline through its own development
programs and through multiple collaborations with pharmaceutical
and biotechnology companies and universities. Forward-Looking
Statements Statements contained in this press release that are not
historical information are forward-looking statements as defined
within the Private Securities Litigation Reform Act of 1995. Such
forward-looking statements are subject to risks and uncertainties
that could cause Avantogen's ("Company") actual results to differ
materially from those projected or implied. Such potential risks
and uncertainties relate, but are not limited, to the results of
clinical trials, product demand and market acceptance, the impact
of competitive products and pricing, effectiveness and pace of
current and future product development, and regulatory approval.
More detailed information on these and additional factors that
could affect the Company's operating and financial results are
described in the Company's annual reports filed or to be filed with
the Australian Stock Exchange. The Company urges all interested
parties to read these reports to gain a better understanding of the
many business and other risks that the Company faces. The
historical results achieved by the Company are not necessarily
indicative of its future prospects. The Company undertakes no
obligation to publicly update or revise any forward-looking
statements, whether as a result of new information, future events
or otherwise.
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