YM BioSciences cancer therapy achieves positive phase II results

Of the 130 nasopharyngeal cancer patients in the intent-to-treat analysis, those in the combination arm were reported to have a 90.6% complete response compared to 51.5% in the radiation-alone group. Complete response is defined as the elimination of tumor at the primary site, locoregional lymph nodes and distant metastases.

TheraCIM h-R3 (nimotuzumab) was administered intravenously at a dose of 100mg/person once a week for eight weeks beginning on the first day of radiotherapy. There was no evidence of the acneiform rash commonly associated with administration of therapeutic agents designed to block the EGF receptor system, corroborating the results of a previous study for TheraCIM h-R3 in head-and-neck cancer.

“No other product targeting the EGF receptor has demonstrated a difference in response rates of this magnitude,” said David Allan, chairman of YM BioSciences.

“This result adds further justification to YM’s approach of combining TheraCIM h-R3 with radiation or as a monotherapy in a variety of cancers including head-and-neck, metastatic pancreatic and pediatric and adult glioma, all of which conditions are currently being tested in a variety of clinical trials.”

TheraCIM h-R3 is currently in a phase I/II trial in pediatric glioma from which preliminary data are expected in January 2005 and in a trial in metastatic pancreatic cancer, for which a clinical milestone is expected in Q3, 2005. YM’s European partner, Oncoscience AG, anticipates initiating a phase III pivotal trial in adult glioma in Q1, 2005, designed as a trial leading to approval for registration.