MGI PHARMA Stops Phase 3 Irofulven Clinical Trial for Refractory Pancreatic Cancer Patients
MINNEAPOLIS--(BUSINESS WIRE)--April 17, 2002--MGI PHARMA, INC., (Nasdaq:MOGN - news) today announced that it has stopped its Phase 3 clinical trial of its anti-cancer drug candidate, irofulven, for gemcitabine-refractory pancreatic cancer patients.
Despite evidence of irofulven activity, preliminary analysis of the Phase 3 data by an independent Data and Safety Monitoring Board (DSMB) indicated that the comparator agent 5-fluorouracil (5-FU) demonstrated a greater than expected survival benefit, making it statistically improbable that the final study results could achieve MGI's planned objectives for the trial. For this reason, MGI will no longer pursue this specific indication for irofulven in gemcitabine-refractory pancreatic cancer. Irofulven will continue to be available to currently-enrolled pancreatic cancer patients in this trial who are experiencing clinical benefit.
``Certainly, we are disappointed with this recent development. Although irofulven appears to have provided benefit to some pancreatic cancer patients in this trial, it was surprising that 5-FU performed substantially above the trial design assumptions,'' said Chuck Blitzer, MGI's president and CEO. ``This Phase 3 trial of irofulven for the treatment of pancreatic cancer was but one trial in MGI's larger program to treat a variety of solid tumors and we will now focus our energies on other ongoing and planned clinical trials of irofulven.''
The Company plans to continue its broad irofulven development program, including the evaluation of irofulven as monotherapy as well as in combination therapy for tumor types affecting large numbers of patients. Previous and ongoing Phase 2 clinical trials have demonstrated activity of irofulven in other tumors, such as ovarian, prostate, and hepatocellular cancer. In preclinical models, irofulven has demonstrated profound anti-tumor activity when combined with other agents, leading to a series of Phase 1 clinical trials of irofulven in combination with approved agents such as irinotecan, gemcitabine, docetaxel, and cisplatin. Combination therapies represent MGI's best opportunity to develop irofulven for use in prevalent tumor types, such as breast, lung, and colon cancers.
``Refractory pancreatic cancer remains one of the most difficult cancers to treat and it is unfortunate that there currently remains no truly effective therapy for this patient population,'' said Michael Cullen, M.D., the Company's chief medical officer... |
