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New ulcerative colitis drug alternative to surgery

March 12, 2012 12:00:00 AM PDT
It's embarrassing, it's painful and almost a million people suffer in silence, some too shy to even tell their doctors. Inflammation in the intestines can make people miserable. Now a new treatment is changing patients' lives.

Ulcerative colitis occurs when ulcers and inflammation form on the lining of the colon and intestine. Uncomfortable symptoms can result, with multiple trips to the restroom every day.

"It's hard to tell your friends what's wrong, and you just kind of have to withdraw from life," said Dr. William J. Sandborn, chief of gastroenterology, UC San Diego Health System.

Sandborn says patients can have surgery, but that means removing the colon and requires an ileostomy bag.

Instead, there's an experimental therapy available.

"What we think is happening with this medication is that it's promoting healing of that inflamed lining of the bowel," said Sandborn.

MDX-1100 works by blocking a protein called chemokine, clearing it from the body so inflammation can't occur. Current drugs can hinder the immune system, lead to infection and even increase the risk of cancer. MDX-1100 promotes healing.

"It seems to be really targeting the colon, so it leaves much of the rest of the body alone," said Sandborn.

But if they stop the therapy, symptoms will come back.

Patients get an infusion of the drug about every four weeks. So far, it's shown good results in a Phase One study. It's now in Phase Two of testing. One interesting fact: smoking actually protects patients from ulcerative colitis. Smokers have about half the risk of developing the disease compared to nonsmokers.

STOP SUFFERING IN SILENCE: HOPE FOR ULCERARATIVE COLITIS

ULCERATIVE COLITIS: Ulcerative colitis is a type of inflammatory bowel disease (IBD) that affects the lining of the large intestine (colon) and rectum. The cause of this disease is unknown. However, patients who have this disease generally have a weaker immune system. Stress and particular foods may trigger symptoms in those who possess this disease. The disease affects all age groups, but there have been peaks at ages 15-30 and then again at 50-70. The disease begins in the rectal area and can grow to infect the entire large intestine.

SYMPTOMS INCLUDE: The symptoms vary in intensity and could start suddenly or slowly. Half of patients experience mild symptoms while the other half gets the worse end. They include:

  • Abdominal pain and cramping
  • Weight loss
  • Blood and pus in the stools
  • Fever
  • Light or extreme diarrhea
  • Joint pain or swelling

AVALABLE TREATMENT:

  1. Diet and Nutrition: Certain types of foods may worsen diarrhea and gas symptoms. Eat small amounts of food, drink water, avoid high-fiber foods, limit milk products if you are lactose intolerant, and avoid fatty, greasy or fried foods and sauces.
  2. Stress: Stress increases when the disease is active because it results in an increase in the number of bowel movements a day and can be embarrassing.
  3. Surgery: Surgery to remove the colon will cure ulcerative colitis and removes the threat of colon cancer. Recommended for patients who have: Colitis that does not respond to complete medical therapy, changes in the lining of the colon that are thought to be precancerous, or serious complications such as rupture (perforation) of the colon, severe bleeding (hemorrhage) (Source: National Center for Biotechnology Information).

CHANGING LIVES: There are a number of medications available for patients with less severe cases. However, certain drugs can hinder the immune system, increase risk of colon cancer, or lead to infection. But, there is one new drug available that promotes healing, IP-10 or MDX-1100. It works by blocking a protein called chemokine so inflammation cannot occur. The drug has recently been filed with the FDA for approval. Preclinical studies demonstrate that antibodies targeting IP-10 neutralize the effects of IP-10 and decrease the appearance of the disease progression in animal models of ulcerative colitis and inflammatory bowel disease, as well as multiple sclerosis and rheumatoid arthritis. The Phase 2 trial is expected to enroll up to 106 patients at multiple centers internationally. Patients in the study are randomized to receive either placebo or MDX-1100 (10 mg/kg) every two weeks for a total of four doses. The primary endpoint of the study is response rate at eight weeks. (Source: Drugs.com).


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