>>MINNEAPOLIS & LUGANO, Switzerland--(BUSINESS WIRE)--Jan. 16, 2002--MGI PHARMA, INC., (Nasdaq:MOGN - news) an oncology-focused pharmaceutical company based in Minneapolis, and HELSINN HEALTHCARE SA, a privately owned Swiss pharmaceutical group, today announced that patient treatment is completed and the data analysis is underway for the pivotal Phase 3 trials of their investigational agent, palonosetron. Palonosetron is a potent, highly selective 5-HT3-receptor antagonist in development in North America and Europe for the prevention of chemotherapy-induced nausea and vomiting (CINV). Submission of the New Drug Application (NDA) for palonosetron is now planned to occur in the third quarter of 2002.
The Phase 3 clinical trial program was initiated in April 2000 and was designed to compare intravenous (IV) palonosetron to currently marketed 5-HT3 antagonists. The trials were conducted at more than 130 medical centers across North America and Europe, with more than 1,800 cancer patients receiving either highly- or moderately-emetogenic chemotherapy. Based on the extended half-life of palonosetron and the results of a Phase 2 trial, the efficacy of palonosetron in the Phase 3 trial is being assessed over Day 2 through Day 5 following treatment, in addition to the primary efficacy measure of complete response during the 24-hour period after the start of chemotherapy.
``We are pleased to have completed all patient treatment and to have begun analysis of the data collected in the palonosetron Phase 3 clinical program,'' said Luigi Baroni, senior director of Scientific Affairs Division at HELSINN. ``The Phase 2 clinical trial results were promising, and we are hopeful that the Phase 3 palonosetron data will demonstrate that it can make a difference for cancer patients suffering from CINV.''
``The half-life of other available 5-HT3 receptor antagonists ranges from approximately five to nine hours, whereas palonosetron has a plasma elimination half-life of nearly 40 hours,'' notes Dr. John MacDonald, senior vice president of Research and Development at MGI. ``The activity seen with palonosetron in the Phase 2 trial, coupled with its safety profile observed to date, led to the initiation of a Phase 3 program to assess the ability of the drug to provide prolonged protection against CINV with a single dose.''
About Palonosetron
Palonosetron is a highly potent 5-HT3-receptor antagonist in Phase 3 development for the prevention of CINV, which is estimated to occur in 85 percent of cancer patients undergoing chemotherapy. If untreated, CINV can result in a delay or even discontinuation of chemotherapy treatment. Palonosetron is highly selective with a strong binding affinity for the 5-HT3 receptor, and has a long half-life.
More than 1,000 subjects have participated in Phase 1 and Phase 2 trials of palonosetron. The most frequent adverse events associated with palonosetron are similar to those seen with other 5-HT3 receptor antagonists and include headache and constipation, which are generally mild to moderate.
In April of 2001, MGI and HELSINN signed an agreement granting MGI the exclusive U.S. and Canadian licensing and distribution rights to palonosetron. Once approved, palonosetron will compete in the $1 billion North American CINV treatment market.<<
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