YM BioSciences was advised by its European partner, Oncoscience AG, that a phase II trial in children with brain cancer (glioma) utilizing the EGF receptor monoclonal antibody (h-R3) as a monotherapy achieved the clinical milestone that permits conversion of the trial into a pivotal trial in this population.
The new study will be a randomized phase III trial comparing radiation (the standard-of-care) to radiation plus h-R3 as a first-line therapy following surgery. YM has been advised that the trial is expected to enroll 100 patients and is targeted for completion in the second quarter of 2006.
“Although the results are preliminary in nature, we have been advised that at least three patients responded to the treatment, allowing the early conversion of the trial into a more significant pivotal trial. This is a welcome and unanticipated result,” said David Allan, chairman of YM BioSciences.
The study is being conducted in Germany by YM’s partner in Europe, Oncoscience AG, and is the first trial of this antibody as a monotherapy and its first trial in children.
In previous clinical trials in adult glioma, head and neck cancer and nasopharyngeal cancer, TheraCIM h-R3/Theraloc has been shown to significantly improve the therapeutic effects of radiation.
A parallel monotherapy trial, also being conducted in Germany in metastatic pancreatic cancer has enrolled 14 patients to date and is targeted to complete its first clinical assessment in mid-2005 following the review of the first 30 patients in that trial. Application has been made for a randomized trial in adults with glioma and the trial in children could be supportive of that application.
Theraloc/TheraCIM has been awarded orphan drug designation by both the European health regulatory authority – EMEA – and by the FDA in the US for treatment of glioma.