New Study for the treatment of Crohn's Disease

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.

The HARMONY Study

The purpose of the HARMONY study is to assess the safety and efficacy of an investigational drug called HuZAF, in patients with moderate to severe CD. HuZAF is a humanized anti-Interferon-gamma (anti-IFN-ã) monoclonal antibody, which binds and blocks IFN-ã, a protein in the immune system that is involved in inflammation. Antibodies are proteins normally produced by our immune system to help fight off foreign substances. Scientists have been able to make therapeutic humanized monoclonal antibodies, similar to the antibodies in our bodies, to target diseases.

Participants will be randomized, assigned by chance, to one of five treatment groups consisting of: four groups differing in the amount of study drug given and one placebo group. The initial dose of study drug will be given intravenously, injected into a vein in the arm. Four weeks later, three subsequent doses of study drug will be given subcutaneously, through the skin, every four weeks for three doses. Patients will be followed for approximately six months after receiving their final dose.

Eligible patients include:
• Patients 18-70 years old
• Patients with moderate to severe Crohns disease
• Patients who have had Crohns disease for at least 6 months
• Patients who have previously been treated for Crohns disease

The HARMONY study is an international study enrolling up to 175 patients with research sites in the United States, Canada and Europe. This study is currently enrolling patients.

For more information on the HARMONY study or how to take part in it, call 1-800-772-0482 or email InfoCenter@PDL.com or visit our website at www.harmonystudy.com.