Vol. 12 No. 2 - February, 2010

New treatment shown to reduce recurrence of debilitating diarrhea

Results of phase 2 clinical trial published in the New England Journal of Medicine

A treatment developed by MassBiologics (MBL) of the UMass Medical School and Medarex, a subsidiary of Bristol-Myers Squibb Co., shows promise in treating a debilitating form of diarrhea. When given with standard antibiotics, the treatment, a fully human monoclonal antibody, was shown to reduce recurrence of the disease by 72 percent in patients enrolled in a Phase 2 clinical trial. The results of the trial are reported in the article “Treatment with Monoclonal Antibodies against Clostridium difficile Toxins” published in the Jan. 21 issue of the New England Journal of Medicine (NEJM).

The team at MBL is gratified that we have been able to discover effective antibodies,

and then translate the discovery to a product with the collaboration of our colleagues at Medarex.

Donna Ambrosino, MD, executive director of MBL

“We are pleased that this new treatment had such a significant impact for these patients,” said Donna Ambrosino, MD, executive director of MBL, professor of pediatrics and senior author of the NEJM paper. “This disease is a growing public health problem and the need for effective treatment options is quite clear. The team at MBL is gratified that we have been able to discover effective antibodies, and then translate the discovery to a product with the collaboration of our colleagues at Medarex.”

Clostridium difficile (C. difficile) is a bacterium commonly found in the human gastrointestinal tract. It is normally not harmful, but it can grow out of control under certain conditions and colonize the gastrointestinal tract. This can occur when patients are treated with antibiotics for other infections, which can kill the “good” bacteria that helps keep C. difficile in check. When C. difficile is allowed to grow unchecked in the gastrointestinal tract, it produces large amounts of toxins, which can cause severe diarrhea and damage the lining of the large intestine. The incidence of C. difficile infection (CDI) in the United States is rapidly increasing, with rates doubling from 2000 to 2005.

C. difficile infects more than 300,000 people each year in the United States and is most common among hospitalized patients and residents of long-term care facilities. Recently the emergence of an epidemic strain of C. difficile has been implicated in severe outbreaks of CDI in the United States, Canada and the United Kingdom, and has affected otherwise healthy individuals in the community. The strain appears to cause both more severe illness initially, and a subsequently higher rate of relapse.

“The trial results are impressive,” Lorraine Kyne, MD, MPH, wrote in an NEJM editorial accompanying the paper’s publication. “This novel non-antibiotic approach to secondary prevention is likely to offer hope to physicians and patients battling C. difficile infection.”