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Discovery May Lead to First Medical Treatment for Celiac Disease

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

Celiac.com 02/26/2003 - WOODLAND HILLS, Calif., Feb. 19, 2003/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 sub fraction 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 Zengens 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.

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Zengens 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., Zengens 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 Zengens 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 dont 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. Zengens 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.

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 managements 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.

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Hi Allie and welcome First off, I know 3 years was a long wait, but at 17 you've figured out celiac way before many people do. That should make a big impact on minimising its effects and helping you with the diet, so, bizarrely enough, congratulations! A lot of good advice has been brought together in this thread: Don't worry that your symptoms are bad now. As you follow the diet your body will begin healing itself and you're still very young so hopefully this will go really smoothly. Think in terms of the next 6 months rather than weeks however, recovery will likely take a little time. Eat as healthily as you can, lots of whole foods and try to avoid the gluten free processed substitutes as your digestive system needs all the help it can get at this moment. You may want to avoid dairy as well for now and think about reintroducing it later. This site has been really helpful to me and others. I hope you find it just as useful. Best of luck! ps, your increased reaction to gluten during the challenge phase was perfectly normal. Many find that reintroducing it much worse than the initial affects and take some time to get over the challenge. That's why you'll see lots of posts here urging folks to 'stay on gluten' till their testing is complete!

Hi! My daughter is 19 was diagnosed at age 16. It took about 12-18 month s for her to fully heal from the damage and feel "normal" again. Also because of the damage done she had reactions to dairy, so you may want to try no or minimum dairy until youre fully healed. Just a suggestion. Hope you start feeling well soon!

Hi yall! New to this blog, but really glad it exists because I have lots of questions. First off, I'm Allie! I'm 17 and newly diagnosed Celiac after about 3 years of searching for answers. I initially went gluten-free on the recommendation of a friend, I felt better in about a month and then my pediatric gastroenterologist had me do the gluten challenge, and my symptoms were the worst they have ever been, and ones I barely noticed before became very present. I did the biopsy and was diagnosed, it's been about 2 weeks and my symptoms are still pretty bad, although my diet has no known sources of gluten or cross contamination. Wondering if anyone has any input on healing post gluten challenge, any tips or how long it took for you would be quite helpful! Thanks

Might want to look into a keto diet, I have UC on top of celiacs and keto is working great Yeah I have major nerve and brain issues with gluten, gluten ataxia with nerve issues and brain issues. Seems to cause my body to attack my brain and nerve system. My brain stumbles fogs, and starts looping, the confusion causes me to become really irritable, I call it going Mr Hyde. Like my mind will start looping constantly on thoughts and not move driving me literally mad, or it used to. Now days it is primary the numbness anger but the gut issues and sometimes random motor loss limit me motionless to the floor now days for the duration of the major anger effects. Used to be a lot more mental then painful gut. I did a mental trauma post on it on while back where I came out about all my mental issues with gluten.

^^^^^^ good info, tips and tricks^^^^^^^^^ yes, crumbs will make you sick. also, breathing flour/pancake mix, etc that is in the air because eventually, you're going to swallow some.