Millennium Pharmaceuticals Inc announced the initiation of a multicenter phase II clinical trial of Velcade in patients with relapsed or refractory mantle cell lymphoma. The single-arm, open-label, three-stage study will assess time to progression, response rate, duration of response and overall survival in patients with relapsed or progressive mantle cell lymphoma following one or two prior chemotherapeutic regimens.

"This trial is a high priority at Millennium because new therapies are urgently needed for this type of lymphoma," said Barry Greene, general manager, oncology at Millennium. "Preclinical and clinical studies that were recently presented at the American Society for Clinical Oncology (ASCO) meeting provided encouraging data that contributed to our decision to move forward with a phase II trial for mantle cell lymphoma."

The clinical trial is being conducted at multiple sites in North America and U.K., and will enroll approximately 152 patients with relapsed or refractory mantle cell lymphoma who have received one or two prior lines of therapy. Response rates will be analyzed at two interim points to determine the utility of the study.

"Following the recent launch of Velcade in multiple myeloma, Millennium continues to be committed to strategically and expeditiously developing Velcade in other malignancies," added Greene. "This trial is an integral part of a broad development program for Velcade in non-Hodgkin's lymphoma."

Velcade and proteasome inhibition represent a completely new approach to treating cancer. The development of this product is based on the Company's deep understanding of cancer disease pathways and the effect of proteasome inhibition on those pathways. The proteasome is an enzyme complex that exists in all cells and plays an important role in degrading proteins that control the cell cycle and cellular processes. By blocking the proteasome, Velcade disrupts numerous biologic pathways, including those related to the growth and survival of cancer cells.