Point's Phase 3
NSCLC program consists of two randomized, double blind placebo controlled trials in up to 800 patients at approximately 100 sites in North America.
Point is currently studying it lead product candidate, talabostat, in a Phase 3
trial in NSCLC.
We expect to request an end-of-Phase 2 meeting with the FDA by the end of 2005 to prepare for initiation of the Phase 3
CF program, which we hope to begin in early 2006.
The completion of enrollment in this Phase 3
clinical trial is an important milestone in our efforts to complete the clinical development of, seek regulatory approval for and, if we are successful, make Canvaxin(TM) available to treat patients with this deadly disease," said David F.
Maxim plans to file an application for approval to market Ceplene for the treatment of Stage IV malignant melanoma in Europe in November based upon the 36-month results from the M01 Phase 3
trial with additional support provided by the final results from the M0103 trial.
announced today the initiation of its Phase 3
clinical study of AI-700(TM), an ultrasound contrast agent designed for detecting coronary artery disease in patients with ischemic heart disease.
MGI has exclusive North American marketing rights for palonosetron, which is in Phase 3
development for CINV.