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FDA Approves Clinical Trial of BioBalance Corporation's Probactrix for Possible Celiac Disease Treatment

Celiac.com 12/27/2005 - The BioBalance Corp. (BioBalance), a wholly owned subsidiary of New York Health Care (OTC BB: BBAL), announced today that it has received approval to begin a small-scale clinical trial of its proprietary biotherapeutic agent, Probactrix, in the dietary management of patients with celiac disease, a chronic disorder of the gastrointestinal (GI) tract.

The Company also announced that it has responded to the U.S. Food and Drug Administration (FDA) regarding questions received earlier this year on the Companys Investigational New Drug (IND) application for Probactrix as a prescription drug for pouchitis, a frequent complication following bowel surgery.

The pilot study for celiac will take place at Rambam Medical Center in Haifa, Israel. Dr. Rami Eliakim, the Centers Director of Gastroenterology, is the principal investigator. The study will be conducted in approximately 38 celiac patients to demonstrate the ability of a medical food formulation of Probactrix to modify the bacterial flora in the GI tract and improve quality of life. Probactrix has been proven to displace pathogenic bacteria in the GI tract and prevent their re-colonization, restoring and maintaining a healthy balance of intestinal flora without the potential negative consequences of antibiotic use.

We are very excited to have approval to initiate this celiac study and to have provided a comprehensive response to FDA questions on our pouchitis IND, said Dennis ODonnell, BioBalances President and CEO.

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Celiac disease is an inherited condition where gluten proteins found in grains trigger an immune system attack on the lining of the small intestine. While celiac disease is rarely life threatening, it is a life altering disorder with symptoms such as diarrhea, fatigue, nausea and weight loss. Celiac is also linked to other autoimmune disorders and is now believed to lead to osteoporosis, anemia, infertility and cancer if left untreated. Diagnosis is often difficult because of the range of GI symptoms. A 2001 survey found that celiac patients in the U.S. suffer for 11 years on average before they are successfully diagnosed. Estimates from the NIH indicate that as many as one in 100 Americans have celiac disease, with significantly higher levels found in Finland, Italy, Ireland and Israel.

Dr. Robert Hoerr, BioBalances Vice President of Medical & Regulatory Affairs, commented, Recent studies have identified a potential link between the overgrowth of pathogenic bacteria in the gastrointestinal tract and the symptoms of celiac disease. We are pleased to participate in this study, which will test the use of Probactrix as a means of modifying the bacterial flora in the GI tract and its impact on quality of life for these individuals.

Contacts:
Dennis ODonnell
CEO
The BioBalance Corp
Tel: (212) 679-7778
Fax: (212) 679-7774

Stanley Wunderlich
CEO
Consulting For Strategic Growth
Tel: (800) 625-2236
Fax: (212)337-8089

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1 Response:

 
Brendan Dougherty
Rating: ratingfullratingfullratingfullratingfullratingfull Unrated
said this on
24 Feb 2008 2:18:03 PM PDT
I was wondering where I could obtain information about participating in the clinical trials with the new enzyme.




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JaneWhoLovesRain, what is odder to me than that there is an older disease that Doctor's have forgotten that explains many of the same symptom's and doctor's do not even think about it today since the "War on Pellagra" was declared over a 100 years and why doctor's don't (at least in the West) think about it any more. Dr. Heaney wrote a nice online article about this topic. http://blogs.creighton.edu/heaney/2013/11/18/pellagra-and-the-four-ds/ Here is fairly recent article about how Pellagra can present in patients and the title says' it all from the International Journal of Dermatology. https://www.researchgate.net/publication/227807440_Pellagra_Dermatitis_dementia_and_diarrhea Dermatitis, dementia and Diarrhea are the 3 D's (4th D is death) of Pellagra. Typically it is only diagnosed today if you are in a subset of the population like an alcoholic for example or you have a gastric bypass. See this article from the New England Journal of Medicine http://www.nejm.org/doi/full/10.1056/NEJMicm050641 and despite all the signs of Pellagra (skin issues etc.) . . .. Pellagra in it native tongue (Italian) where it was first diagnosed was called "rough/sour skin" who knows that today??????? Very few I would venture to guess. The NEJM can only say they have "Pellagra-like dermatitis" it has been so long since any doctor's seen it they can't (with confidence) diagnose it clinically. But taking Niacinamide 3/day for 6 months can help alleviate your symptom's if indeed the DH of Celiac is the dermatitis of Pellagra being medically misdiagnosed. Here is a an article featured on celiac.com about why/how Pellagra can be confused for Celiac disease. https://www.celiac.com/articles/24658/1/A-Differential-Diagnosis-How-Pellagra-Can-be-Confused-with-Celiac-Disease/Page1.html Because they haven't seen Pellagra in 75+ years no one recognizes it anymore. ****this is not medical advice. I hope this is helpful. Knitty Kitty and I are the Niacin warriors on this board. See this thread where Knitty Kitty says Niacin helped the itching of DH. If that is so then it might help your DH (if you have it) and your GI problems too if they are caused by co-morbid Pellagra. see my blog post about where I say "I had Celiac Disease and Developed Pellagra" that talks about this in more detail. Again good luck and your continued journey and I hope this is helpful. 2 Timothy 2: 7 ?Consider what I say; and the Lord give thee understanding in all things? this included. posterboy by the grace of God,

I should say I am confused about how to interpret--- Does this mean celiac or no celiac? Thank you all---I greatly appreciate it.

KathleenH, I swear by MatteosPizza and they make National Delivery. I have been known to buy them by the dozen. https://www.matteospizza.com/ BellaMonica's is not a bad corn based crust. By not bad I mean "suprisingly good" that can be bought at most grocery stores. Here is there ZIP locator page to see if they are carried in your local area. http://glutenfreepizza.typepad.com/gluten-free-pizza/where-to-find-bella-monica.html I hope this is helpful. posterboy,

Hey all--have Hashimoto's and am being worked up for epigastric discomfort and IBS like symptoms--- My blood work had an IgA within the lower end of normal range, negative TTG, but weakly positive DGP. My endoscopy showed a "nodular" duodenum with the biopsy stating there was "reactive lymphoid hyperplasia"... I have a follow-up with the GI in 3 weeks. Wondering about any help?

DH wasn't linked to celiacs until 1967 from my research...