MagForce Nanotechnologies AG (Berlin , Germany) has submitted the product file for NanoTherm® to Medcert GmbH, the medical certification and testing company which serves as Notified Body for the certification of medical products. With this step, MagForce has now commenced the conformity assessment procedure for its Nano-Cancer® therapy. Following successful completion of this conformity assessment procedure and EC type testing of the magnetic field applicator, MagForce will be able to apply the CE European conformity marking and to market its Nano-Cancer® therapy throughout the European Union.
In early November, the results of a pivotal clinical trial were published demonstrating the efficacy of the new therapy in patients with recurrent glioblastoma, and it is upon these results that the application for European regulatory approval is based. The primary study objective, which was to extend the median survival time following tumor recurrence by three months compared to a historical control group, was significantly exceeded in the actual results. Following treatment with Nano-Cancer® and accompanying radiotherapy, the median survival time following diagnosis of the first tumor recurrence was 13.4 months. Compared to the 6.2-month median survival time following recurrence observed in a recently published EORTC study, the patient survival time was shown to be statistically highly significant longer (p-value < 0.01).
"With the glioblastoma study successfully concluded and the product file now submitted for review, we have attained our most important objectives for this year, which we are of course extremely pleased about," said Dr. Uwe Maschek, CEO of MagForce Nanotechnologies AG. "We are confident that we are on a solid course to complete the certification procedure for our Nano-Cancer® therapy in the first half of 2010. Over the months ahead, we will thus be able to concentrate our resources entirely on preparations for the commercialization phase."