Genentech and XOMA Initiate Phase III Trial for Anti-CD11a Monoclonal Antibody in Psoriasis Patients

Genentech, a leading biotechnology company, and XOMA Ltd. have initiated a Phase III clinical trial for an investigational monoclonal antibody, anti-CD11a (hu1124), to treat moderate-to-severe plaque psoriasis. This decision follows promising Phase II trial results, which indicate the potential for anti-CD11a to prevent T-cell activation and migration, key contributors to inflammation in psoriasis. The trial aims to enroll approximately 30 sites in the United States and Canada, with a second Phase III study planned for early 2000.

Key Takeaways:

• The Phase III trial is focused on an investigational monoclonal antibody, anti-CD11a (hu1124), designed to prevent T-cell activation and migration in psoriasis patients.
• The study will target patients with moderate-to-severe plaque psoriasis, a chronic skin disorder affecting over seven million people in the U.S. and millions globally.
• The trial's primary objective is to assess the efficacy and safety of anti-CD11a in improving psoriasis symptoms, with a secondary goal of investigating its potential as a therapeutic agent.
• Psoriasis is a complex condition with unknown causes, involving increased T-cell activation, adhesion, and migration, leading to inflammation and abnormal skin cell growth.
• There is currently no cure for psoriasis, and existing treatments often focus on managing symptoms rather than addressing the underlying causes.
• Genentech and XOMA's collaborative effort aims to develop a novel therapeutic approach for psoriasis patients, who face significant unmet medical needs.
• The biotechnology companies have a long history of developing innovative treatments, with Genentech currently marketing seven products directly in the United States.
• XOMA has a proven track record in developing biopharmaceuticals, including its BPI platform targeting bacterial and fungal infections, immunologic, and inflammatory disorders.

Statistics:

• Approximately 7 million people in the U.S. and millions worldwide suffer from psoriasis, a chronic skin disorder with no cure.
• Psoriasis occurs when new skin cells grow too rapidly, resulting in inflamed, swollen, scaly patches of skin, most commonly on the scalp, knees, elbows, and trunk.
• Increased activation, adhesion, and migration of T-cells contribute to inflammation and abnormal skin cell growth in psoriasis patients.
• The primary aim of the Phase III trial is to assess the efficacy and safety of anti-CD11a in treating moderate-to-severe plaque psoriasis patients.

Sources:

• Genentech, Inc.
• XOMA Ltd.
• National Psoriasis Foundation
• Securities Act of 1933
• Securities Exchange Act of 1934