Results suggest new hope for patients with refractory chronic lymphocytic leukemia Data to support BLA submission
BARCELONA, SPAIN, June 12 ---ILEXTM Oncology, Inc. (NASDAQ: ILXO) and LeukoSite, Inc. (NASDAQ: LKST) today announced final results from an international, multi-center, pivotal Phase II clinical trial of CAMPATHR for the treatment of patients with B-cell chronic lymphocytic leukemia (CLL) who are refractory to fludarabine. Results of the trial were presented this weekend at the 4th Congress of the European Haematology Association (EHA) by Michael J. Keating, MB, BS, of the M.D. Anderson Cancer Center, one of the trial's principal investigators and an internationally recognized expert in CLL. The companies plan to submit a Biologics License Application (BLA) based largely on these results later this year.
"The results of this trial are encouraging," said Dr. Keating, Associate Head for Clinical Research and Professor of Medicine and internist for the Department of Leukemia at M.D. Anderson Cancer Center. "The data suggest that CAMPATH may provide an important new treatment option for fludarabine-refractory patients, a group for whom the prognosis has, to date, been extremely poor. While the treatment of patients with leukemia has relied on chemotherapeutic agents, the use of monoclonal antibodies is an innovative approach to circumventing the disease's mechanisms for resistance."
The non-comparative trial, involved 93 previously treated patients who had received prior alkylating agents and failed fludarabine therapy (median of three prior treatment regimens). For these patients, the median life expectancy is usually six to nine months.
In the trial, patients participating at the 20 clinical sites in the United
States and Europe received 30 mg of CAMPATH on an outpatient basis, as an intravenous
infusion, three times a week, for four to 12 weeks. The dose was gradually escalated over
the first week to 30 mg, in or
Contact: Deborah Sibley, ILEX Oncology