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Discovery May Lead to First Medical Treatment for Celiac Disease
Wednesday February 19, 11:00 am ET

- Genetic Digestive Disorder Affects an Estimated One in 250 Americans -

WOODLAND HILLS, Calif., Feb. 19 /PRNewswire/ -- Results from a new study may
lead to the first medical treatment for celiac disease, a hereditary
digestive disease that can damage the small intestine and interfere with the
absorption of nutrients from food. Celiac disease sufferers cannot tolerate
gluten, a protein that is found in wheat, barley and rye. Celiac disease
affects an estimated one in 250 Americans, mostly those of European descent,
and there is no known medical treatment or cure.


Zengen, Inc. researchers discovered that a synthetic form of
alpha-Melanocyte-Stimulating Hormone (alpha-MSH) has an anti-inflammatory
effect in celiac mucosa, the inside lining of the intestinal tract that
absorbs food into the body. A naturally occurring molecule, alpha-MSH
modulates inflammatory and immune responses. Data confirming the presence of
alpha-MSH in celiac mucosa suggests the presence of a local reaction of the
molecule to control the inflammatory response elicited by gliadin. Gliadin
is the subfraction of gluten that acts as a toxin or poison in people with
celiac disease; it causes an immune reaction, resulting in damage to the
small intestine and an inability to digest and absorb nutrients necessary
for health and growth (malabsorption).

The findings, "Anti-Inflammatory Effects of alpha-Melanocyte-Stimulating
Hormone in Celiac Intestinal Mucosa," appear in the February 20, 2003 issue
of NeuroImmunoModulation, the official journal of the International Society
for Neuroimmunomodulation.

"Our research suggests that locally-produced alpha-MSH modulates
inflammation and perhaps limits epithelial damage in patients with celiac
disease," stated James M. Lipton, Ph.D, study investigator, chief scientific
officer and director of Zengen. "We are particularly excited by these
findings as these data, coupled with abundant evidence of the
anti-inflammatory and anti-infective activity of Zengen's novel molecules
based on alpha-MSH, further validate our research and development efforts in
numerous areas including celiac disease. These positive results will be used
to guide further advancements toward clinical use of the molecules."

The study used human celiac mucosa cells in culture. Researchers collected
duodenal biopsy pairs from 53 adult celiac patients (34 untreated patients
and 19 celiac patients on a gluten-free diet) and 14 normal subjects and
conducted three series of experiments in order to determine: (1) mucosal
immunoreactivity for alpha-MSH and melanocortin receptors (MCRs), and gene
expression of alpha-MSH precursor pro-opiomelanocortin and MCRs; (2)
alpha-MSH and inflammatory cytokine production by duodenal specimens in
vitro, and the influence of synthetic alpha-MSH on such cytokine production,
and; (3) the influence of stimulation with gliadin on alpha-MSH and cytokine
production in vitro and the effect of alpha-MSH on gliadin-stimulated
cytokine production.

Results suggest a localized anti-inflammatory influence based on alpha-MSH
and its receptors: duodenal mucosa showed evidence of alpha-MSH and two of
its receptor subtypes, MC1R and MC5R. Further, alpha-MSH and MC1R
immunoreactivity was more intense in cell specimens from celiac patients and
release of interleukin 6 (a lymphokine that stimulates the inflammatory
response) from gliadin-stimulated duodenal mucosa was inhibited by synthetic
alpha-MSH.

"Patients suffering from celiac disease currently have no medical options
beyond a lifetime adherence to a strict, gluten-free diet," added Dr.
Lipton. "Clearly, if we can control the inflammatory responses that are a
major part of celiac disease and limit the immunosuppression, this could
lead to the first medical treatment to help the millions worldwide suffering
from this genetic disease."

Zengen's novel molecules were developed from more than 25 years of original
research in the US, Europe and Asia on peptide molecules derived from
alpha-Melanocyte-Stimulating Hormone (alpha-MSH). James Lipton, Ph.D.,
Zengen's chief scientific officer, chairman of the scientific advisory board
and director, and his collaborators first demonstrated that alpha-MSH
possesses anti-inflammatory properties and uncovered the specific activity
of the carboxy-terminal tripeptide region (C-terminal peptide) of the
alpha-MSH peptide. These discoveries led to the development of Zengen's
proprietary peptide molecules, including CZEN 002, a synthetic octapeptide.
Zengen is currently conducting phase I/II clinical trials with CZEN 002 in
vaginitis.

About Celiac Disease

According to the National Institute of Diabetes and Digestive and Kidney
Diseases (NIDDK) of the National Institutes of Health (NIH), celiac disease
(CD), also known as gluten intolerance, celiac sprue or gluten sensitive
enteropathy, affects an estimated one in 250 Americans. Celiac disease is a
condition in which there is a chronic reaction to proteins called glutens
which causes destruction of the villi in the small intestine, with resulting
malabsorption of nutrients. A genetic disease, it may appear at any time in
the life of a person with a hereditary predisposition.

Celiac disease is often misdiagnosed, symptoms are varied and there is no
current medical treatment or cure. Patients who suffer from celiac disease
currently have only one alternative -- adherence to a lifetime, gluten-free
diet. If left untreated, celiac disease can lead to malabsorption, which, in
turn, can lead to malnutrition. Celiac disease is especially serious in
children and adolescents, who need adequate nutrition to develop properly.
Further, people with celiac disease who don't maintain a strict, gluten-free
diet have a greater chance of developing one of several forms of cancer,
particularly intestinal lymphoma. Other long-term complications include
anemia, diabetes mellitus, hypothyroidism, osteoporosis, seizures and
peripheral neuropathy.

About Zengen, Inc

Zengen, Inc. is a biopharmaceutical company focused on discovering,
developing and commercializing innovative products to treat and prevent
infection and inflammation through application of its proprietary peptide
technologies. Zengen's novel molecules offer broad-based anti-infective and
anti-inflammatory solutions for multiple diseases and disorders, ranging
from yeast infection to transplantation, and have the potential to
significantly alter the way these diseases are treated. For more information
about Zengen, please visit www.zengen.com <http://www.zengen.com>.

Zengen, Inc. Forward-Looking Statement Disclaimer

This announcement may contain, in addition to historical information,
certain forward-looking statements that involve risks and uncertainties.
Such statements reflect management's current views and are based on certain
assumptions. Actual results could differ materially from those currently
anticipated as a result of a number of factors. The company is developing
several products for potential future marketing. There can be no assurance
that such development efforts will succeed, that such products will receive
required regulatory clearance or that, even if such regulatory clearance
were received, such products would ultimately achieve commercial success.


  _____

Source: Zengen, Inc.

Disclaimer: I have no connection or financial interest in this company.

Michael Thorn
CeliACTIONetwork
http://groups.yahoo.com/group/CeliACTIONetwork/
email: [log in to unmask]

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