Nimotuzumab, a humanized monoclonal antibody that targets the epidermal growth factor receptor (EGFR), is currently in varying stages of development in a number of trials, including colorectal cancer, adult and pediatric glioma, non-small-cell lung cancer and pancreatic cancer. During the first quarter of fiscal 2008:
- YM initiated enrollment for a Phase II colorectal cancer trial in
Canada. As of today, 30 patients have been enrolled in the first 50-
patient cohort, with recruitment of this cohort expected to be
completed by the end of calendar 2007 and data from this cohort are
expected to be reported in early calendar 2008. The endpoints of the
trial include Objective Response Rate (ORR), Progression Free
Survival (PFS), Overall Survival (OS) and the rates and durations of
Stable Disease (SD), as well as safety.
- YM USA was cleared by the US FDA to expand its second-line clinical
trial in children with DIPG into the US.
- YM reported positive preliminary results of a Phase I/II trial of
nimotuzumab in combination with radiation for the treatment of non-
small-cell lung cancer (NSCLC).
- Oncoscience AG reported completion of patient enrollment in the
Phase III, first-line, pediatric DIPG trial.
- Oncoscience AG reported initiation of late-stage trials designed to
be supportive of registration in adult glioma and pancreatic cancer.
- Subsequent to the end of the quarter:
- YM received clearance from Health Canada to extend into Canada the
188-patient multi-centre randomized, placebo controlled
Phase IIb/IIIa study in chemotherapy-naive patients with locally
advanced or metastatic pancreatic ca
|SOURCE YM BioSciences Inc.|
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