CROHNS PATIENTS NEEDED FOR NEW STUDY

Protein Design Labs is studying a new approach to treating Crohns disease in patients with moderate-to-severe Crohns. Known as the HARMONY study, this clinical trial will evaluate the safety and effectiveness of an investigational drug in men and women 18-70 years old. For more information on the HARMONY study or how to take part in it, please call: 1-800-772-0482 email InfoCenter@PDL.com or visit www.harmonystudy.com

Protein Design Labs, a biotechnology company based in Fremont, CA, is studying a new approach to treating Crohns disease. Twenty-five study sites in the United States, Canada, and Europe are currently enrolling patients with moderate-to-severe Crohns. Known as the HARMONY study, this clinical trial will evaluate the safety and effectiveness of an investigational drug called HuZAF.

HuZAF is a humanized monoclonal antibody--an antibody that is produced in the laboratory from a single clone. (Antibodies are proteins normally produced by our immune system to help fight off foreign substances.) HuZAF targets a specific protein called interferon gamma (IFN-g). Excess amounts of IFN-g have been found in people with Crohns disease. Researchers believe that this excess of IFN-g may be linked to intestinal inflammation and other symptoms of Crohns. By binding to the IFN-g molecule and blocking its activity, HuZAF may help to prevent inflammation.

Patients who participate in this study will be randomized (assigned by chance) to one of five treatment groups. Four of these groups will each receive a different amount of HuZAF; the fifth group will receive a placebo (a harmless substance). The initial dose of the drug will be given intravenously, injected into a vein in the arm. Four weeks later, three additional doses of the drug will be given subcutaneously (through the skin). Patients will be followed for six months after receiving their final dose.

If you are between the ages of 18 and 70, have been diagnosed for at least six months, and have received prior treatment for Crohns disease, you may be eligible to participate in this study. For further information, please call 1-800-772-0482 or e-mail InfoCenter@pdl.com or visit www.harmonystudy.com.