Biogen Idec has initiated a randomised, controlled, registration trial of an investigational anti-CD23 monoclonal antibody, lumiliximab, for patients with chronic lymphocytic leukaemia (CLL). The trial will compare treatment with lumiliximab in combination with fludaribine, cyclophosphamide and rituximab (FCR), an emerging standard of care, to FCR alone in patients with CLL that has relapsed or failed to respond to initial therapy.
Biogen Idec also announced that lumiliximab was granted Fast Track and Orphan Drug designations by the US Food and Drug Administration (FDA) for the above indication. Biogen Idec owns the worldwide rights to lumiliximab.
"We are pleased that the FDA has recognized the unmet medical need of patients with chronic lymphocytic leukemia, and we believe that this fast track designation may be an important step towards bringing lumiliximab more rapidly to the market," said David Parkinson, M.D., senior vice president, Oncology Research and Development, Biogen Idec.
Fast Track programmes are designed to facilitate the development and expedite the review of new drugs or biologics that are intended to treat serious or life-threatening conditions and that may fill an unmet medical need. Orphan drug designation is a special status given to products for rare diseases or conditions upon request of a sponsor and approval from the FDA. Orphan drug designation may qualify recipients for exclusive marketing rights in the United States for seven years if the company is first to receive marketing approval.
The newly initiated lumiliximab registration trial enrolled the first randomized U.S. patient January 17, 2007. The patient was treated on January 22, 2007, by Kelly Pendergrass, M.D., at Kansas City Cancer Center in Kansas City, Mo. The first international patient was also treated on January 22, 2007, by Dr. Paul Cannell at Royal Perth Hospital in Perth, Australia. The study will ultimately enroll approximately 276 patients worldwide at more than 90 centres.
Dr. Pendergrass, clinical investigator and medical oncologist, said, "Kansas City Cancer Center is excited to participate in the lumiliximab clinical trial because our patients rely on us for industry-leading new treatments."
"We are encouraged to continue studying this novel CD23 antibody in combination with FCR following positive data that showed the potential for improved outcomes for CLL patients," said Ian Flinn, M.D., Ph.D., director, Hematologic Malignancies Research, Sarah Cannon Research Institute and clinical director, Sarah Cannon Blood and Marrow Transplant Program, Tennessee Oncology. "The development of this antibody is significant because more targeted therapeutic options are needed for CLL patients."
Data from a Phase I/II study on lumiliximab was presented at the 48th Annual Meeting of the American Society of Hematology (ASH) in December 2006. When added to the FCR regimen, lumiliximab demonstrated a 52 percent complete response (CR) rate in patients who have CLL that was progressing after prior therapy. CR rate is a predictor of progression-free survival in CLL patients.
"Building on our history of successful development and commercialization of antibodies, we are excited at the recent initiation of this lumiliximab trial in conjunction with the initiation of a pivotal trial for our anti-CD80 monoclonal antibody, galiximab," added Dr. Parkinson. "With our strong pipeline, we hope to continue to be a leader in developing new and novel approaches to cancer treatment worldwide."
The LUCID Trial (evaLuation of lUmiliximab in Combination with FCR in patIents with relapseD CLL) is a randomized, multi-centre study (152CL201) of the anti-CD23 monoclonal antibody lumiliximab in combination with FCR, compared with FCR alone. CD23 is highly expressed on B-CLL cells. The primary study objective is to compare the clinical benefit of each treatment arm in subjects with relapsed CLL. Complete response (CR) rate is the primary study endpoint.