MagForce Applying to European Regulatory Body to Market its Nano-Cancer® Therapy

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."

Nano-Cancer®Therapy Effective in Treating Brain Tumors

MagForce Nanotechnologies AG, a Berlin-based medical technology company majority owned by Nanostart AG, has announced the successful completion of final trials demonstrating the efficacy of its Nano-Cancer® therapy in patients with recurrent glioblastoma, a frequent form of brain tumor which is highly malignant. The actual study results significantly exceeded the study objective.

According to a previous study among a large patient population, the median survival time following diagnosis of a glioblastoma recurrence and treatment with conventional therapy (surgery, chemotherapy and radiation) is 6.2 months. The primary objective for the Nano-Cancer® therapy study was to demonstrate an extension of the median survival time in the recruited patient group by three months compared to this historical control group.

In fact, the median survival time of the 59 patients participating in the final trials was 13.4 months following treatment with Nano-Cancer® therapy in conjunction with radiation. The median survival time was thus significantly greater, more than double that of the control population.

The results were even more remarkable in that Nano-Cancer® therapy was tested not on newly diagnosed patients with primary tumors but rather as a study involving patients who had already endured treatment with conventional therapies, as well as the unpleasant effects generally associated with these. Following regulatory approval of the new therapy, it is expected that it will also be available for use in treating other types of localized tumors, as these are generally responsive to the same principle of using warmth to destroy or degrade cancer cells.

MagForce founder and chief scientific officer Dr. Andreas Jordan commented, “The results demonstrate the potential of Nano-Cancer® therapy, which at the same time has minimal patient side effects. Our vision is to establish this new technology alongside surgery, chemotherapy and radiation as an additional pillar of cancer therapy.”

Marco Beckmann, CEO of Nanostart AG, went on to add, “We enthusiastically congratulate Dr. Jordan and his team on the superb study results. It is my belief that we may thank nanotechnology for a historical advance in medical science.”

In addition to its high efficacy of which has now been conclusively demonstrated, Nano-Cancer® therapy offers an additional and very significant advantage compared to the existing conventional therapy alternatives of surgical intervention, chemotherapy and radiation: Nano-Cancer® therapy is tolerated extremely well by patients and, despite its high efficacy, has no serious or unpleasant side effects.

The results of these clinical trials will now form the basis of application for EU regulatory approval for the new therapy, which will be submitted before the end of this year. Once EU regulatory approval has been obtained, MagForce will be able to market its Nano-Cancer® therapy throughout the European Union. The detailed study results will be published shortly in a medical journal.

Nano-Cancer® therapy represents a completely new way to fight cancer and is world’s first approach to use magnetic nanoparticles to treat tumors with virtually no side effects. This is done by injecting specially coated iron oxide nanoparticles directly and precisely into the tumor so that they remain concentrated in the tumor and do not diffuse into the surrounding healthy tissue. The nanoparticles within the tumor are then heated to an exact temperature by externally applying an external magnetic field. In this way, tumor temperatures of up to 70°C (158°F) can be precisely attained within a fraction of a degree. This heat damages the tumor or destroys it completely. During the treatment procedure, patients feel only a moderate warming sensation.

Nanostart AG has been Lead Investor in MagForce Nanotechnologies since 2004 and currently holds approx. 77% of its shares.