Oncoscience AG announces completion of patient enrollment in phase III trial of NIMOTUZUMAB, in first line treatment of children with inoperable brain cancer
Oncoscience | September 12th, 2007
Clearance Received for Two Additional Late-Stage Trials in Adult Glioma and Pancreatic Cancer
Today Oncoscience AG (Wedel, Germany) announced, about the development of the humanized EGFR-targeting monoclonal antibody, nimotuzumab, has recruited the 40th and final patient in its trial combining nimotuzumab with radiation for the treatment of children and adolescents suffering from diffuse intrinsic pontine glioma (DIPG), an inoperable form of cancer for which treatment options are severely limited.
The Phase III trial was conducted by an international group of paediatric oncologists under the lead of principal investigator Professor Udo Bode from University of Bonn, Germany. The primary end-point of the trial is progression-free survival; secondary endpoints are survival, response rate and improvement of neurological symptoms. Results are expected end of first half 2008.
In addition, Oncoscience has advised that two additional late-stage trials have been cleared to commence in Europe:
A randomized multi-centre study in which nimotuzumab and the current standard of care (radiotherapy with concomitant and adjuvant temozolamid) will be compared to the current standard of care in patients with glioblastoma multiforme (GBM). The study is expected to recruit 190 patients within 24 months. The primary end-point for this trial is Progression-Free Survival, with Response Rate and Symptom Control among the secondary endpoints.
Nimotuzumab has received Orphan Drug designation from EMEA.
A randomized multi-centre study in chemotherapy-naive patients suffering from locally advanced or metastatic pancreatic cancer who will be treated with either gemcitabine plus nimotuzumab or gemcitabine plus placebo is expected to recruit 188 patients within 24 months. The primary end-point for this trial is Response Rate with Overall Survival among the secondary endpoints.
YM BioSciences, the licensor of nimotuzumab, anticipates that it will extend the European trial in pancreatic cancer into Canada by submitting the protocol to Canadian health regulatory authorities to add Canadian site to accelerate recruitment