Stefan[a]
PRNewswire
YM BioSciences announces first patient enrolled in EGFr MAb Trial
YM BioSciences Inc., the cancer drug development company with an advanced-stage portfolio, and its majority-owned subsidiary, CIMYM Inc., today announced that their European licensee for TheraCIM hR3, Oncoscience AG, has enrolled the first patient in a 47-patient rolling Phase I/II trial in paediatric glioma, a form of brain cancer. TheraCIM hR3 is a humanized monoclonal antibody (MAb) targeting the Epidermal Growth Factor receptor (EGFr).
"This is our second anti-cancer drug to enter late-stage clinical trials, reflecting the maturation of our broad oncology portfolio," said David Allan, Chairman and CEO of YM BioSciences. "This is the first of a series of trials which, if successful, could lead to registration of TheraCIM hR3 by late 2006."
The Phase I/II study will examine the efficacy of TheraCIM hR3 monotherapy in treating recurring, highly malignant brain gliomas (astrocytomas and glioblastomas) in children. Only patients who have failed the first line of standard treatment (surgery, radiation and possibly one course of chemotherapy) will be enrolled in the study. The dosing regiment consists of one intravenous injection of TheraCIM hR3 per week for 6 weeks.
The first part of the study will include 18 patients. If 3 of the 18 patients demonstrate stable disease or better, a second stage of study, which will include an additional 29 patients, will be conducted using TheraCIM hR3 in combination with radiation therapy. Enrolment in the first stage is anticipated to be completed by September 2004. The trial is being performed in 28 hospitals of the Berlin-Frankfurt-Munich Cooperative Group in Germany and Austria, the largest of three study groups dealing with children´s cancer.
Oncoscience has applied for Orphan status in both paediatric and adult glioma. Oncoscience is proposing to initiate several additional studies for TheraCIM hR3, including enrolling 80 patients in a Phase III registration trial in adult glioma that is anticipated to start in Q4 2004.
Malignant gliomas are cancerous brain tumours that occur in approximately 40,000 patients in North American and Europe each year. The standard treatment for patients with newly diagnosed malignant gliomas is surgery, followed by radiation therapy and systemic chemotherapy.
14 June 2004