Monday, September 29, 2008

Prochymal Article - News Gazette

It can make you miserable. It's expensive to treat, and it involves an area of the body nobody wants to discuss in polite conversation. But if you're one of the unlucky people to have Crohn's disease, a type of inflammatory bowel disorder, help may be in sight.

A Carle Clinic doctor sees some potential in a new drug composed of adult stem cells for the more severe cases of Crohn's, and is now enrolling patients to try it at Carle.
"Basically, this is rescue therapy," said Dr. Eugene Greenberg, a gastroenterologist running the local trial of the drug Prochymal.

Crohn's disease is a chronic, lifelong inflammation of the digestive tract lining and bowels that affects about 500,000 people in the U.S., according to the drug maker, Osiris Therapeutics.
Symptoms include severe abdominal pain, cramping and diarrhea.

People who have it in its mild form live a fairly normal life with some modifications and treatments, Greenberg said. But in its more severe form, he adds, "it's pretty miserable. It's pain, it interferes with the quality of life, it interferes with holding a job."

And at a time when millions of people can't afford health insurance, Crohn's is one pricey disease to treat. The medications per single patient run about $23,000 a year, Greenberg said.
Traditional treatments for Crohn's include steroids, immunosuppressant drugs and biologic drugs.

Prochymal is composed of stem cells that have been obtained from the bone marrow of normal, healthy adult volunteers. Studies have shown the cells don't require matching between the donor and recipient, and they may have both immunosuppressive and healing benefits for people with Crohn's, according to the drug company.

Carle, one of 55 study sites in the U.S., is entering the trial in its third phase.

Greenberg said there is reason to think Prochymal will work. And since there haven't been any serious adverse reactions in earlier phases of the trial, Prochymal appears to be safe, he said – though, he qualifies, time and wider use will tell.

Patients entering this trial will receive the drug in infusion form, and some will receive a placebo.
The third phase of the study is intended to establish the drug's safety and how long remission lasts in patients with moderate to severe symptoms of Crohn's.

To qualify, patients must have confirmed Crohn's disease of the ileum (part of the small intestine) or the colon or both, and either have not improved with or can't tolerate at least one steroid, one immunosuppressant and one biologic therapy.

Qualified patients must also be between age 18 and 70, in general good health and able to go to
Carle Clinic for up to 10 visits over three months.

Patients must not be pregnant or nursing; allergic to X-ray dye, pork or beef; or in any other research studies.

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