Ulcerative Colitis

In severe cases, individuals may have diarrhea 10 to 20 times a day, which may lead to dehydration, fever, hospitalization and blood transfusions.

Participants in the study, which is sponsored by PDL BioPharma, Inc., will receive visilizumab, a monoclonal antibody that is designed to target and block the action of T cells, the same cells believed to cause UC, with the aim of significantly reducing the symptoms of UC and potentially delaying the need for colectomy, or surgical removal of the colon.

“More than one million people worldwide suffer from Plevy, M.D., an associate professor of medicine in the Division of Gastroenterology, Hepatology and Nutrition at the University of Pittsburgh School of Medicine.

“An estimated 25 to 40 percent of these patients eventually fail to respond to oral and intravenous steroids, and their only treatment option is invasive surgery to remove their colon.” Dr.

Plevy also is a co-director of the Inflammatory Bowel Disease Center and a ...

The cause of pouchitis is not known, though it is believed to result from an immune response to pathogenic bacteria in the pouch flora.

There are no currently approved treatments for pouchitis.

Current management involves short-term and occasionally chronic treatment with antibiotics.

The phase I/II, randomized, placebo-controlled, multi-center study will be conducted in approximately 63 antibiotic-dependent pouchitis patients to demonstrate the ability of a prescription formulation of Probactrix to maintain symptomatic response of pouchitis symptoms after antibiotic withdrawal.

The principal investigators of the trial are Darrell S.

Pardi, MD, and William J.

Sandborn, MD, of the Division of Gastroenterology at the Mayo Clinic in Rochester, Minnesota.

"FDA approval of this clinical trial represents a major milestone for the company," said Dennis O'Donnell, BioBalance's President & CEO.

"We continue to make tremendous strides in advancing the science behind Probactrix and validating the extensive overseas clinical history of this product." Probactrix is a patented, single strain of non-pathogenic E.coli M-17 that was originally isolated from the intestinal microflora of a healthy ...

"I missed a lot of school, three months in Grade 10," plus six weeks in Grade 8 and three months at the end of Grade 9, but that didn’t affect his class standing.

By January 2004, his condition had deteriorated to the point that doctors and the family decided Justin should have an ileostomy, to remove damaged sections of his intestines, and a pouch attached to his side to catch waste.

Justin was nervous and concerned but knew this would offer a better quality of life.

"Today, I can’t picture not having it," he says with a smile.

"It took me a year to adjust to it, but now I feel great, eat anything I want, in moderation, have a girlfriend, and an active life." Last summer, he spent a week at a national camp in Alberta for young people with ostomies.

He was in Japan last April, sponsored by Manulife, to represent the IWK Health Centre at Expo 2005 in Aichi and visited a children’s hospital.

He met Alanis Morrisette at the Canadian pavilion, and had tea at the Canadian ambassador’s home in Tokyo.

"I had done a lot for the IWK while I was there," he says, "including designing a thank-you card for them." Justin loves art, one of his best school subjects.

"Drawing is a passion.

I paint in oils and acrylics and do graphics on the computer." He’s also musical, playing keyboard and guitar with a band that has yet to perform in public.

He was Grade 10 class representative on student council before colitis hit him that year...