PHARMACY

Study: Experimental vaccine may prevent IBD, colon cancer

BY Allison Cerra

NEW YORK An experimental vaccine against an abnormal protein found in some tumors has the potential to delay the onset of inflammatory bowel disease and in turn prevent progression to colon cancer, according to researchers at the University of Pittsburgh School of Medicine.

People with such chronic inflammatory disorders as IBD are at greater risk for developing cancer at the inflamed site, said senior author Olivera Finn, Ph.D., professor and chair, Department of Immunology, Pitt School of Medicine. The vaccine made by Finn’s team is directed against an abnormal variant of a self-made cell protein called MUC1, which is altered and produced in excess in both IBD and colon cancer.

“Our experiments indicate that boosting the immune response against this protein early in the disease can delay IBD development, control inflammation and thereby reduce the risk of future cancers,” Finn said. “These findings suggest also that the early stages of chronic inflammation might be considered a premalignant condition.”

This study suggested that in the future the vaccine might be considered as part of the therapeutic regimen for IBD as well. The experimental vaccine has been studied in patients with colon and pancreatic cancer and currently is being tested as a prevention measure in patients who have a high risk for developing colon cancer.

Their findings are reported in Cancer Prevention Research, a journal of the American Association for Cancer Research.

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FDA approves expanded use of Xifaxan

BY Alaric DeArment

SILVER SPRING, Md. The Food and Drug Administration has approved a new use for a drug made by Salix Pharmaceuticals, the FDA announced Wednesday.

The agency approved Salix’s Xifaxan (rifaximin) for treating hepatic encephalopathy, a deterioration in brain functioning in patients with liver disease that results from the liver’s no longer being able to clear toxins from the body.

The drug already had approval for treating traveler’s diarrhea.

“The approval of Xifaxan for this new indication provides an additional treatment optin for patients with liver disease,” FDA Division of Gastroenterology Products deputy director Joyce Korvick said in a statement. “Hepatic encephalopathy occurs commonly in patients with liver disease, and there are few effective treatments for this serious condition.”

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Teva gets tentative approval for argatroban

BY Alaric DeArment

JERUSALEM The Food and Drug Administration has given tentative approval to a generic anticoagulant by Teva Pharmaceutical Industries, Teva announced Thursday.

The FDA gave the authorization to the injected drug argatroban, a generic version of a GlaxoSmithKline drug for treating heparin-induced thrombocytopenia that is branded with the same name. The branded version of the drug has annual sales of around $137 million, according to IMS Health.

A tentative approval means that the generic version of the drug meets the conditions for full approval by the FDA, but it can’t be marketed yet because the patent has not expired.

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