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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.
Acusphere also reported that it has initiated over half the projected number of clinical sites in the pilot phase of the AI-700 Phase 3 program.
M0103 Phase 2 trial and the 241-patient international M0102 Phase 3 trial provide additional clinical data regarding the safety and efficacy of Ceplene that complement the results of the first 305-patient U.
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.