Seattle Genetics Inc has initiated a phase II clinical trial of SGN-30 for the treatment of primary cutaneous anaplastic large cell lymphoma (ALCL). Primary cutaneous ALCL, which is a type of non-Hodgkin's lymphoma that involves the skin, is the company's third clinical indication for SGN-30.
The phase II study is designed to evaluate the anti-tumour activity and tolerability of SGN-30 in up to 40 patients who have relapsed or are resistant to prior therapies.
According to the release, Seattle Genetics is conducting additional phase II studies of SGN-30 in Hodgkin's disease and systemic ALCL. The company has reported data from the first five systemic ALCL patients treated with SGN-30, noting that objective responses were observed in two patients. Seattle Genetics plans to report additional preliminary data from these ongoing phase II studies at the American Society for Hematology (ASH) Annual Meeting in December 2004.
"We are optimistic about the therapeutic potential of SGN-30 in ALCL and believe it may offer a rapid path to regulatory approval," stated Dr. Michael McDonald, Chief Medical Officer of Seattle Genetics. "We are also conducting clinical trials of SGN-30 in Hodgkin's disease as a single agent and are planning future studies in combination with chemotherapy," he added.
SGN-30 is a genetically engineered monoclonal antibody that targets CD30-positive hematologic malignancies, including Hodgkin's disease and certain types of lymphomas and leukaemia. The company has received orphan drug designations from the FDA for SGN-30 in both Hodgkin's disease and T-cell lymphomas, a category that includes ALCL. Seattle Genetics is also conducting preclinical studies to evaluate the potential of SGN-30 in the treatment of immunologic diseases.
Anaplastic large cell lymphoma (ALCL) is a type of T-cell non-Hodgkin's lymphoma.