Study shows ulcerative colitis patients achieve remission with probiotic composition VSL#3

May 19, 2003

ORLANDO, Fla. May 19, 2003 - Researchers reported study results today that demonstrated treatment with the highly concentrated probiotic preparation, VSL#3(TM), achieved a combined induced remission and/or response rate of 86 percent in patients with active mild to moderate ulcerative colitis who were not responding to conventional therapy. "VSL#3 Probiotic Mixture Induces Remission in Patients with Active Ulcerative Colitis" was presented at the annual Digestive Disease Week (DDW) meeting.

Affecting 500,000 Americans, ulcerative colitis (UC) is a form of inflammatory bowel disease that causes the gastrointestinal tract to become red, swollen and ulcerated with sores that eventually bleed. Even if the pathogenesis of UC is not totally clear, there is good evidence to suggest that controlling the balance of the intestinal bacterial flora may be very beneficial for these patients. Numerous clinical studies have shown that the high-concentration probiotic, VSL#3, is effective in controlling and maintaining a healthy balance of the intestinal flora.

"Many ulcerative colitis patients do not respond to conventional treatments and side effects of these medications can be troublesome," said lead investigator Richard Fedorak, MD, professor of medicine and director of the division of gastroenterology at the University of Alberta in Edmonton, Canada. "These results are meaningful because they demonstrate that adding a probiotic with multiple strains and a high concentration of bacteria to the treatment regimen may have the potential to stop this disease in its tracks and avoid any treatment-related side effects."

In the multi-center (Canada, United States and Italy), open-label study, 30 patients with a recent flare-up of mild to moderate UC not responding to conventional medicines were administered four packets of VSL#3 daily (equivalent to 3,600 billion good bacteria) for six weeks. Eligible patients also remained on steady doses of standard UC therapies including mesalamine, oral corticosteroids and azathioprine.

Remission, the primary endpoint, was achieved in 63 percent of patients, and 23 percent of study participants experienced an improvement in symptoms for a combined remission/response rate of 86 percent. Four patients did not respond to VSL#3, and only one patient demonstrated worsened disease activity. No adverse biochemical or clinical effects were observed by adding VSL#3 therapy. Researchers determined the remission and response rates by using the Ulcerative Colitis Clinical Score (UCCS).

Results from the study presented today confirm earlier findings that VSL#3 is effective in the management of serious gastrointestinal disorders such as pouchitis, a major complication following a common surgical procedure in patients with UC. According to the Crohn's and Colitis Foundation of America, approximately 25 percent to 40 percent of patients with UC will require surgery to remove their colon at some time during their illness due to lack of response to treatment. Within twelve months following the surgical intervention and pouch formation, up to 37 percent of patients experience pouchitis, a syndrome characterized by increased stool frequency and fluidity, rectal bleeding, abdominal cramping, incontinence, and fever.

The lead study published in the May 2003 edition of the journal Gastroenterology reported that VSL#3 is effective in the prevention of pouchitis. According to the accompanying editorial, authored by Jeffry A. Katz, MD, associate professor of medicine, Case Western Reserve University School of Medicine, "Given the similarity between pouchitis and ulcerative colitis, probiotic therapy could also prove useful in the maintenance treatment of this condition."

"When looking at studies of probiotics in treating certain GI disorders, it's important to note that different probiotic preparations contain varying amounts of bacterial strains and strengths," said Dr. Fedorak. "We saw positive results with this particular formulation, but the results do not necessarily apply to other probiotics." These differences were noted in Dr. Katz's editorial and previously in a letter to the editor of The New England Journal of Medicine.

In addition to Dr. Fedorak's abstract, other studies on VSL#3 being featured at this year's DDW meeting include:

Additionally, "Origin, Characterization and Mechanisms of Action of the Probiotic VSL#3," was the subject of a presentation at a DDW Spring GRG Symposium entitled, "Host-Microbial Interactions in the GI Tract: Role of Commensal Bacteria and Probiotics."

A patented probiotic therapy, VSL#3 has been evaluated in more clinical trials of serious GI disorders than any probiotic on the market. VSL#3 is different from other probiotic therapies in that it contains numerous strains of bacteria at high concentrations (450 billion). The formulation is marketed by VSL Pharmaceuticals, Inc. and is only available to consumers through the VSL Web site, www.vslpharma.com, or by calling 1 (866) GET-VSL3 (438-8753).
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About Digestive Disease Week (DDW)

Digestive Disease Week (DDW) is the largest international gathering of physicians, researchers and academics in the fields of gastroenterology, hepatology, endoscopy and gastrointestinal surgery. Jointly sponsored by the American Association for the Study of Liver Diseases (AASLD), the American Gastroenterological Association (AGA), the American Society for Gastrointestinal Endoscopy (ASGE) and the Society for Surgery of the Alimentary Tract (SSAT), DDW takes place May 17-22, 2003 in Orlando, Florida. The meeting showcases approximately 5,000 abstracts and hundreds of lectures on the latest advances in GI research, medicine and technology.

About VSL Pharmaceuticals

VSL Pharmaceuticals, Inc. is a new company that has been recently established in North America to oversee the development, production, distribution and use of VSL#3, a proprietary innovative probiotic preparation.

MCS/VSL

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