Immuron is the new name of Anadis. The new Ticker symbol for ASX is IMC. Immuron also has an American Depository Receipts (ADR) on International OTCQX, under the Ticker: IMROY
The Latest Press Releases:
April 17, 2009 Immuron to Acquire IP from Hadassah Medical Center and Collaborate in Clinical Trials (link to pdf)
NEW
YORK and MELBOURNE, April 17, 2009. Immuron (ASX: IMC), a
biopharmaceutical company, today announced an agreement to acquire a
novel Oral Immune Modulation technology from Hadasit, the
commercialization arm of Hadassah Medical Center in Israel.
The
combination of oral immune modulation with Immuron’s existing oral
protein and antibody technology could yield a convenient, all- natural,
side effect free approach to address serious diseases which have
multi-billion dollars markets, including Metabolic Syndrome, Hepatitis
C and Type II Diabetes.
Hadassah Medical Center scientists
have demonstrated that their oral immune modulation approach, used in
combination with Immuron’s own dairy derived antibodies and other
proteins, can directly affect the activity level of regulatory T
cells, a type of immune cell known to have profound effects in
controlling the inflammation in many diseases. This novel approach has
shown positive effects in several validated animal models of human
disease, including type II diabetes and metabolic syndrome.
Immuron will focus its initial clinical development effort with this platform technology on three major diseases having inadequate medical therapy now: Metabolic Syndrome, chronic Hepatitis C (HCV) and Liver Cancer (hepatoma). These conditions represent major pharmaceutical market targets in industrial and developing countries, and can have severe consequences for affected patients.
Immuron
intends to initiate clinical trials for metabolic syndrome and HCV
shortly after the acquisition. Given that the products are intended to
be marketed as a Medical Food in the United States (and under similar
classifications in other countries), it is expected that Immuron can
introduce commercial products for some indications shortly after such
trials, potentially within 2-3 years.
The
new platform technology will also provide an additional layer of patent
protection to strengthen the existing Immuron pipeline products (which
target Traveller’s Diarrhea, HIV/AIDS immune depletion, Mucositis and
Influenza).
The Metabolic
Syndrome is defined as a combination of abdominal obesity,
hyperlipidemia and insulin resistance. Insulin resistance is associated
with a constellation of common clinical conditions, including type II
diabetes, obesity, hypertension, and hypertriglyceridemia. It is
estimated that up to 25% of the western population have manifestations
of this disorder. An analysis by Medco Heath solutions claimed that the
average yearly US pharmacy cost of treating adult patients with
Metabolic Syndrome exceeds $4,000 per patient - more than four times
the average annual drug spend for all other patients. With more than
45 million Americans affected by metabolic syndrome the target market
is large.
Non-alcoholic steatohepatitis (NASH) is a condtion
which considerably overlaps Metabolic Syndrome at the immunological
level, and is one stage on the spectrum of non-alcoholic fatty liver
diseases. It is estimated that 8.6 million obese adult Americans may
have NASH and about 30.1 million may have the milder steatosis. Since
no effective medical therapy is currently available for patients with
non-alcoholic fatty liver diseases, Immuron will also address this
clinical target.
Hepatitis C
virus (HCV) infection affects about 2-3% of the world’s population (170
million people) and in the USA alone between 3-4 million people have
chronic HCV infection. Patients with chronic HCV infection are at high
risk for developing cirrhosis of the liver, end stage liver disease, or
cancer. There are emerging immunological linkages between Hepatitis C
and type II diabetes.
In addition to the acquired Intellectual
Property, Hadasit will provide discounted clinical and laboratory
services to Immuron, providing Immuron with efficiencies in its cost
structure for human clinical trials. In return, Hadasit shall be
issued 19.99% of Immuron’s equity at the time of the approval of the
transaction by Immuron’s shareholders, as well as royalty on selected
Immuron products. A special meeting of Immuron’s shareholders will be
called during May this year to approve this share allocation.
As
part of its due diligence, Immuron commissioned Biocomm Squared
(Biocomm2), to assess the scientific and economic foundation of
Hadasit’s Intellectual Property (IP). The full report prepared by
Biocomm2has been lodged at ASX in conjunction with this announcement
and is available on Immuron’s web site: http://www.immuron.com
Professor
Yaron Ilan from Hadassah Medical Center, a recognized world expert on
oral immune modulation, will become the Medical Director of Immuron.
Prof. Ilan will continue to serve simultaneously as the Director of the
Department of Medicine A and the Deputy Dean of the Hebrew
University-Hadassah Faculty of Medicine.
Dr.
Zeil Rosenberg, CEO of Immuron, noted “This transaction marks a turning
point for Immuron in its quest to lay a firm scientific foundation for
its own technology to address large unmet medical needs”
Dr.
Rafi Hofstein, CEO of Hadasit noted “ Hadasit is happy that its
discoveries can move so quickly into commercial partnership. Our world
class clinical experts are ready and able to get the high quality
clinical data needed to bring this biotechnology innovation to
patients.”
Dr. Oren Fuerst, Head of Business Development at
Immuron noted “ The Hadassit technology provides Immuron with the
ability to address several of the largest markets in the healthcare
sector- Metabolic Syndrome, Diabetes, Hepatitis C, Hepatitis B and HIV.
This transaction can generate large value for shareholders and helps
position the company for profitable commercial partnerships with large
pharmaceutical and consumer health companies .”
April 17, 2009 Immuron Self-affirm its Hyper Immuned Colostrum as GRAS
According to the FDA, self-affirmed GRAS status is awarded to any substance that is generally recognized among qualified experts as having been adequately shown to be safe under conditions of its intended use. The expert panel was composed of recognized physician experts in pediatric immunology, infectious disease, nutrition and clinical trials. They assessed published safety data from a large number of clinical and toxicology studies in reaching their conclusion.
Dr. Zeil Rosenberg, Immuron CEO, noted “With GRAS safety affirmation by such a distinguished panel , and multiple ongoing clinical studies being developed in the US, Israel and Australia, we have initiated partnership discussions with major consumer nutrition focused companies interested in HIV/AIDS, influenza and metabolic syndrome. These are important areas where our antibodies can have major health benefit .”
Dr. Oren Fuerst, the Head of Business Development, noted: “ In addition to the impact on our greatly enhanced ability to market medical food for specific indications, the GRAS affirmation would now allow us to address new markets such as partnerships with major food manufacturers for the creation of unique and patented functional foods as well as opening up to us the entire emerging segment of pet animal health.”
March 24, 2009 Initiation of U.S. sales by Alaven
Alaven Consumer Healthcare, Inc. (ACH) is a privately held consumer health products company located in Marietta, Georgia, and is a sister company to Alaven Pharmaceutical LLC, which develops and markets prescription products treating gastroenterological, women’s health and anemia conditions.
Travelan addresses travelers’ diarrhea (TD), a clinical syndrome resulting from microbial contamination of food and water, due usually to gaps in local sanitation. It is most frequently caused by E.coli toxins. According to the US Center for Disease Control (CDC) in 2008, on average, 30%-50% of all travelers to high-risk areas (about 50 millions persons per year) will develop TD during a 1- to 2-week stay, with each case lasting 3-4 days.
Travelan contains antibodies against 16 strains of E.coli, including those most frequently seen in tourist destinations and has been shown as effective in providing protection from infection with E.coli in numerous double blind placebo controlled clinical studies.
Dr. Oren Fuerst, Head of Business Development of Immuron states: “ Alaven Consumer Healthcare had shown its ability to market products online, and their expertise in doing so should further expedite the market penetration plan they had suggested to us last year when we signed the distribution agreement. ”
“Travelan is an effective solution to one of the most common annoyances in international travel. We are thrilled with the opportunity to offer this product to U.S. and Canadian international travelers,” says David Swenson, General Manager of Alaven Consumer Healthcare, Inc.
January 14, 2009 U.S. Phase II of Biogard announced; Research Grant for HIV antibody Research
San
Francisco and Melbourne -- Jaunuary 14, 2009 -- San Francisco and
Melbourne, Australia---Immuron Ltd. (ASX: IMC ), a biopharmaceutical
company specializing in oral immunotherapy development and antibody
manufacturing, announced today approval for a Phase II human clinical
study in HIV/AIDS patients at a prestigious U.S. AIDS research center,
and the award of a prestigious research grant for an HIV antibody. The
announcement was made during the 27th Annual J.P. Morgan Healthcare
Conference in San Francisco.
The study is being conducted by the
Center for AIDS Research, a prominent NIH funded research program, at
Case Western Reserve University. University Hospitals in Cleveland
Ohio. The study is led by Professors Gopal Yadavalli, Benigno Rodriguez
and Michael Lederman, Associate Director of the Center. The study aims
to document the ability of Immuron’s BioGard ™ hyperimmune bovine
colostrum powder formulation to decrease translocation of gut-derived
microbial products and decrease immune activation in patients with
early stage HIV infection. BioGard contains a mixture of anti-LPS and
other antibodies active at the mucosal surface. The study will begin in
calendar Q1 2009 and positive results could open a window to expanded
trials of BioGard as part of routine HIV/AIDS therapy regimens.
The
study complements a recently announced multi-site clinical trial
sponsored by the Australian National Center in HIV Epidemiology and
Clinical Research (NCHECR) examining the product’s efficacy in HIV/AIDS
patients undergoing intensified therapy for persistent immune
activation.
Dr. Zeil Rosenberg, Immuron CEO, stated, “We are
thrilled with the interest that the Center for AIDS Research has in
initiating this study so rapidly. We are even more hopeful now that our
oral antibodies can create a new paradigm for addressing an emerging
need in HIV patient care.”
Separately, Immuron announces that
Associate Professor Damian Purcell, Head of the Molecular Virology
Laboratory at the University of Melbourne, working with the Australian
Centers for HIV and Hepatitis Virology, has been awarded a research
grant by the Australian Department of Health and Aging to develop and
test an Immuron produced hyperimmune colostrum powder formulation
containing antibodies against HIV envelope antigens.
Dr. Oren
Fuerst, VP Business development of Immuron stated: “Our unique
technology platform allows for the rapid development of targeted
antibodies. In addition to targeting HIV related inflammation, we are
now developing antibodies against the virus causing AIDS itself.”
You can find all the press releases and financial reports under the Australian Stock Exchange website: