Oncoscience AG receives EU orphan drug status for the EGFR monoclonal antibody Nimotuzumab (Theraloc®) for the treatment of pancreatic cancer.
Oncoscience | April 22nd, 2008
Oncoscience AG announced that their anti-cancer drug Nimotuzumab (Theraloc®) has been designated an orphan drug by the European Medicines Agency (EMEA) for the treatment of pancreatic cancer.
OSAG has licensed nimotuzumab for Europe and 20 other countries around the European area and will market the drug under the name „Theraloc®“.
Currently a phase III trial with patients suffering from pancreatic cancer is being conducted. The placebo, double blinded, controlled study in patients with unresectable, metastatic pancreatic cancer compares Gemcitabine + Placebo versus Gemcitabine + Nimotuzumab. At the moment only patients from Germany are enrolled in the study; furthermore patients will be recruited from other parts of the Oncoscience territory.
An additional phase III trial investigating a type of brain cancer, diffuse intrinsic pontine glioma in paediatric patients, is ongoing. Patient recruitment started in April 2006 and was concluded by August 2007. Results from this study are expected to be released during the second half of 2008.
A third phase III trial is being conducted with adult glioma patients suffering grade IV tumors. Patients are randomized and receive a combination therapy of radiation+temozolomide +/- nimotuzumab. Out of the 150 patients needed for the study, 30% have already been recruited.
Oncoscience AG already hold marketing approval in the Ukraine since October 2007 and applied for marketing approval in Europe (EMEA), Switzerland and Russia.