Seattle Genetics, Inc. announced that it has initiated a phase II clinical trial of SGN-30, a monoclonal antibody for the treatment of hematologic malignancies. The study is designed to evaluate the antitumour activity and safety of SGN-30 in patients with Hodgkin's disease or anaplastic large cell lymphoma.

"SGN-30 represents a targeted approach to cancer therapy and may offer a much needed option for patients with advanced hematologic malignancies, where currently available treatments are limited and can cause toxic side effects," stated Clay Siegall, PhD, president and CEO of Seattle Genetics. "Initiating the phase II clinical trial is an important step toward our goal of developing antibody-based therapeutics for patients with cancer."

The single-agent, open label study will accrue up to a total of 80 patients, 40 per disease indication. The trial, which is being conducted at over 10 sites in the United States, is designed to assess the tolerability and antitumour activity of SGN-30 in patients who have relapsed or are refractory to prior therapies.

Seattle Genetics reported data from the phase I multi-dose clinical trial of SGN-30 at the American Society of Hematology annual meeting in December 2003. In the phase I study, 24 patients, in six-patient cohorts, received weekly infusions of SGN-30 at doses ranging from two to twelve milligrams per kilogram. SGN-30 was well tolerated and antitumour activity was observed. One patient with anaplastic large cell lymphoma demonstrated a complete response lasting at least four months and six of the 24 patients had stable disease.

SGN-30 is a genetically engineered monoclonal antibody that targets CD30-positive hematologic malignancies, including Hodgkin's disease and certain types of lymphomas and leukemias. In July 2003, the company received orphan drug designation from the FDA for SGN-30 in Hodgkin's disease. Additionally, Seattle Genetics is conducting preclinical studies to evaluate the potential of SGN-30 for the treatment of immunologic diseases.