Business Editors
/Health/Medical Writers
NEWPORT BEACH, Calif.
Vaccine adjuvants are integral for use in vaccine
development as
they help determine the nature of the body's immune response and aid
in directing
the body to stimulate either the production of antibodies
or cell-mediated immunity. 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.
mcleod kittenz
Morphotek Announces Acceptance of Investigational New Drug
Application for MORAb-003 a Humanized Monoclonal Antibody for the Treatment of Advanced Ovarian Can
"
This just-published 284-page, comprehensive report includes the
very latest etiological and U
.mixon diagnosed
EXTON, Pa. epidemiological data on the most
prevalent 11 disease categories.1016/j.D. "While
the development of cancer
vaccines is promising, we believe it may be significantly strengthened
by the use of GPI-0100 to induce a stronger immune response in cancer
patients. The present study
shows that GPI-0100 appears to be safe and to stimulate a strong
immune response in man, warranting
its use in further vaccine studies. Certain saponins, naturally occurring glycosides found in
many
plants, have been shown to stimulate both a humoral and
cell-mediated immunity, but their toxicity
and instability limits
their use in vaccines.
About Australian Cancer Technology (www. 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.pancreatic ended
MORAb-003 is a monoclonal antibody that has high specificity for
a number
of different cancers, including ovarian, breast, colorectal, lung, renal, and
brain.
com.01.
Further clinical trials at Memorial Sloan-Kettering are being
planned for melanoma, neuroblastoma
, breast cancer, ovarian cancer and
chronic myeloid leukemia patients using the GPI-0100 adjuvant
.ewing memorials
The antibody targets a receptor
present at high density on cancer cells, and offers a very high
degree of
specificity for malignant tissues.morphotek. Sass, Executive Vice President and Chief Operating
Officer,
Morphotek, Inc. Disease Incidence and Prevalence.AustCancer Vaccine Adjuvant Demonstrates
Enhanced Immune Response in Prostate Cancer Patients
pancreatic neuroblastoma
In pre-clinical cancer models the antibody
has demonstrated that it
can efficiently kill chemo-refractory tumors and suppress growth in xenograft
studies.The Most Prevalent and Costly Diseases in the U.S. Detailed in a New Disease Incidence and
Prevalence Report Published by Medtech Insight
"
In the prostate cancer patients treated, all
of the vaccines
containing GPI-0100 were found to be safe.S.mixon rhabdomyosarcoma
, Morphotek, Inc.pancreatic cns
medtechinsight. This
is the first report of the
use of GPI-0100 in humans. 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.mcleod kittenz
Worldwide, more than 182,000 new patients will be diagnosed with
this
form of cancer (World Health Organization).S. The results of the study
data were reported in an electronic
publication of the journal Vaccine
(doi:10. Cohorts of five patients received vaccine
formulations
containing the same amount of conjugate but with
escalating doses (100, 300, 1,000 or 3,000ug) of
GPI-0100 to assess
safety.neuroblastoma prematurely
Morphotek is also marketing an exciting new antibody platform for
developing
high-quality, fully human therapeutic antibodies that significantly
reduces the royalty burdens associated
with current technologies.----Some of the
most prevalent and costly diseases and disorders in the
United States
include surgical and traumatic wounds, breast, prostate and colon
cancer, cardiovascular
and peripheral vascular disease, diabetes,
osteoarthritis, osteoporosis, Alzheimer's disease, depressive
disorder, cataracts, endometriosis, infertility, prostate disease,
incontinence, sleep apnea and
asthma, among others. Overall, patients
receiving GPI-0100 had significantly less pain or inflammation
at the
injection sites and fewer systemic symptoms compared to patients
receiving QS-21 who had
similar antibody titers.ovarian heroic
The Phase I clinical
study is designed as an open label single dose escalation
safety study in
patients with chemo-refractive ovarian cancer. "We are in the late stages of
development
for a second monoclonal antibody, MORAb-009, which is an antibody
that targets a high percentage
of pancreatic cancers and other difficult to
treat malignancies.
Business Editors/Health/Medical
Writers
SYDNEY, Australia + SAN DIEGO----
Results from a Phase I Study Conducted at
Memorial Sloan-Kettering
Cancer Center Utilizing GPI-0100 Published in Vaccine
Australian
Cancer Technology (AustCancer) (ASX:ACU) today
announced that Phase I clinical studies utilizing
the company's lead
vaccine immunostimulant GPI-0100 demonstrated enhanced immune response
in patients
with relapsed prostate cancer.mixon ewing
Phone: 610-423-6106
kittenz roscoe
"An unmet medical need
exists for patients with advanced, chemo-refractory
ovarian cancer," stated Nicholas Nicolaides,
President and Chief Executive
Officer. Patients had no evidence of disease except for rising
PSA
levels.
GPI-0100 is AustCancer's lead compound for use in the active
immunotherapy of cancer and
some chronic infectious diseases. The company also
markets revisys(TM), a branded line of medical
nutritionals designed
for people with special needs, including those undergoing cancer
treatments
.rhabdomyosarcoma remembrances
Morphotek(R), Inc.vaccine. In addition, a
Phase I folate kidney cancer vaccine using GPI
-0100 is being studied
by Endocyte at Baylor University, Texas.Tributes in memory of the courageous
people who have lost their battle with cancer.
remembrances painful
"
Ovarian cancer ranks fourth in cancer deaths
among women, accounting for
more deaths than any other cancer of the reproductive system (American
Cancer
Society). A
semi-synthetic compound derived from saponins, GPI-0100 acts by
up-regulating
the body's immune system and stimulating both humoral
and an effective T-cell immunity with CTL production
.mixon kittenz
Sass, Executive Vice President and
Chief Operating Officer of Morphotek. These include: 1) acute
and chronic
skin wounds including illness-related wounds, pressure ulcers, and
surgical and traumatic
wounds; 2) blood disorders including anemia and
hemophilia; 3) cancer, including bladder, breast
, bronchus and lung,
cervical/uterine, colon/rectal, leukemia, lymphoma, nervous system,
oral,
ovarian, pancreatic, prostate, and skin cancer; 4)
cardiovascular diseases and disorders including
atherosclerosis,
congestive heart failure, hypercholesterolemia, hypertension, and
ischemic heart
disease; pacing disorders including arrhythmias and
sudden cardiac death, and valvular heart disease;
and 5) human
immunodeficiency virus (HIV) and acquired immune deficiency syndrome
(AIDS).
This
detailed reference source also includes 109 detailed
exhibits. For more on the company's
products
and services, please see www.
The impact of immunotherapies on biomarkers such as PSA and their
effects
on disease progression has yet to be conclusively validated. AustCancer's Pentrys(TM)
anti-cancer
vaccine is being evaluated in prostate cancer patients in
Phase IIb clinical studies and the company
is advancing immune
enhancing adjuvants in three Phase I cancer trials.mcleod sharron
S.
For further information
visit http://www., Medtech Insight is
the leading provider of business information and market intelligence
for the medical technology marketplace. The dose-escalation study sought to determine the optimal
(in terms of antibody response) and safe dose range of the adjuvant
GPI-0100 when used with a
bivalent conjugate vaccine (glycosylated
MUC-2-KLH and Globo H-KLH). AustCancer is traded on the
Australian Stock Exchange
(ASX) under the symbol ACU.sharron kittenz
In 2005, it is estimated that there will be
22,220 new cases of
ovarian cancer in the U.
CONTACT:
Dr.com
The
Phase I study, led by Susan Slovin, M.
Subsequent studies in 14 patients at doses of 1,000, 3,000
and
5,000ug were carried out using a more purified GPI-0100.
"Currently, there is no standard
of care for patients who have
rising PSA levels after primary therapy failed," said Paul Hopper,
AustCancer's chief executive officer.patty memorials
and approximately 16,000 women will die from the
disease
. is a biotechnology company focused on the generation of
proprietary organisms for product discovery
and development.medtechinsight.com/ReportA700., assistant professor
of medicine at Memorial Sloan
-Kettering Cancer Center, included
patients with progressive prostate disease after primary surgery
or
radiotherapy. Another
cohort of 9 patients was enrolled in a second trial with the same
vaccine
using the competitive saponin adjuvant QS-21 at 100ug, a dose
established in earlier trials. Patients
receiving the two GPI-0100 batches showed
comparable grade I local reaction but slightly less grade
II local
reactivity using the more purified GPI-0100.com.
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 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.
ended courageous
"In pre-clinical studies MORAb
-003 has been shown to be active
against chemo-refractory ovarian tumors."
"This is the first
of several antibodies in our product portfolio that the
company plans on advancing into clinical
development for cancer, inflammation
and infectious diseases," added Philip M. Most adjuvants primarily
elicit only a
humoral response and are not capable of stimulating the production of
cytotoxic
T lymphocytes (T-cells), potentially limiting their use in
protection against certain diseases such
as cancer and different viral
infections. The historical results achieved by the
company are not
necessarily indicative of its future prospects.
sarcoma ovarian
This
versatile technology has been successfully
applied to microbes, plants, and
mammals to yield genetically diverse offspring that are suitable
for
pharmaceutical and agricultural product development in the areas of antibody
and protein therapeutics
, high-titer protein manufacturing, and drug target
discovery. Medtech Insight
announces the publication
of a new Market + Technology Report
examining these and many other increasingly burdensome health
problems, including current incidence and prevalence figures for 80
separate diseases/disorders
for the years 1996-2001, 2003, and 2004
when available, titled "U. Serologic responses, flow
cytometric
analysis and the impact on PSA levels were evaluated in all
patients.memorials pancreatic
We will file an IND by the
end of this year. The Company has
a validated and patented platform technology called morphogenics
that rapidly
enhances the natural process of genetic evolution within a targeted host to
yield
variants with novel, commercially important output traits. Internally,
Morphotek employs its morphogenics
technology to develop optimized therapeutic
antibodies for the treatment of cancer, inflammatory
and infectious diseases.S.072). The company has established a Level 1 ADR
stock program in the U
. 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.patty mixon
We look forward to updating
the progress
of this antibody as it advances through clinical trials. Philip M.html
Now a
division of Windhover Information Inc.2005.au
Australian Cancer Technology (AustCancer) is an
international
biotechnology company developing a broad oncology-related product
portfolio.gastrointestinal memorials
Chapter
6 of this thoroughly researched report details metabolic
diseases and disorders including cholelithiasis
, chronic kidney
disease, diabetes mellitus, end-stage renal disease, and urolithiasis. We are very
encouraged by the results found in this study
and intend to evaluate GPI-0100 further in several
vaccine development
projects including cancer and infectious agent vaccines. AustCancer has acquired
the North American marketing rights
for RP101, a promising pancreatic cancer drug currently in Phase
II
clinical studies through a subsidiary company, Resistys Inc, a joint
venture with Bioaccelerate
of New York.rhabdomyosarcoma prematurely
today announced that
the United States Food and Drug Administration has accepted its
Investigational New Drug (IND) Application for treatment of advanced ovarian
cancer with MORAb
-003, a humanized monoclonal antibody.
Also covered is 7) musculoskeletal diseases including osteoarthritis
and rheumatoid arthritis, carpel tunnel syndrome, Duchenne's muscular
dystrophy, and osteoporosis;
8) neurologic diseases and disorders
including Alzheimer's disease, amyotrophic lateral sclerosis
(ALS),
cerebrovascular diseases including arteriovenous malformation,
cerebral aneurysm and stroke
, epilepsy, Huntington's disease,
hydrocephalus, multiple sclerosis, myasthenia gravis, and Parkinson
's
disease; psychiatric disorders including bipolar disorder, depression,
and schizophrenia; 9
) ophthalmologic diseases including cataracts and
glaucoma; 10) reproductive and genitourinary disorders
including
endometriosis, male and female infertility, benign prostatic
hyperplasia (BPH), erectile
dysfunction, and urinary incontinence; and
11) respiratory diseases and disorders including adult
respiratory
distress syndrome, apnea, asthma, chronic obstructive pulmonary
diseases such as chronic
bronchitis and emphysema, cystic fibrosis,
infectious diseases including pneumonia and tuberculosis
, pleural
disorders including empyema, pleural effusion and pneumothorax,
pulmonary embolism, respiratory
failure, and restrictive pulmonary
diseases. A full table of contents and ordering information can
be
viewed at http://www. Different from
certain immune stimulatory saponins, GPI-0100 has superior
stability
and safety profile, making it an ideal candidate for the development
of novel therapeutics
or preventive vaccines.
GPI-0100 currently is being evaluated in a Phase I study in
combination
with HER-2 vaccine for breast cancer at the University of
Alabama at Birmingham Comprehensive Cancer
Center.austcancer. Such forward-looking
statements are subject to risks and uncertainties that could
cause
Australian Cancer Technology's ("company") actual results to differ
materially from those
projected or implied.subsequent ewing
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