Following more than 20 years of research and development efforts, MagForce Nanotechnologies AG (Frankfurt Stock Exchange: MF6), a majority-owned subsidiary of Nanostart AG, has received regulatory approval for medical use of its Nano-Cancer® therapy throughout the European Union. This momentous event marks the world’s first nanoparticle-based cancer treatment to come to market.
Approval was granted not just for treating one particular type of brain tumor but rather, without limitation, for the treatment of all primary brain tumors. Furthermore, the therapy was approved as a primary therapy, meaning that it – like surgical resection, chemotherapy, and radiation – may be used as a first-line treatment for patients who have been newly diagnosed with brain tumors.
This novel therapy involves the instillation directly into the tumor of a fluid containing special iron oxide nanoparticles. These magnetic nanoparticles are then subjected to a controlled magnetic field so that they oscillate and generate heat. The elevated temperature within the tumor causes the cancer cells to be damaged or destroyed.
This approval follows successful completion of the conformity evaluation procedure of the company’s NanoTherm® magnetic fluid by Medcert GmbH and of its NanoActivator® magnetic field applicator by Berlin Cert GmbH. Both of these medical certification and testing companies are officially authorized centers for the conformity evaluation of medical devices.
“With regulatory approval now received, our company has entered a new phase. MagForce is transforming itself from a medical R&D company to a commercial provider of medical technology,” said Dr. Peter Heinrich, CEO of MagForce Nanotechnologies.
MagForce founder and CSO Dr. Andreas Jordan added, “After research and development efforts spanning more than 20 years, we now have regulatory approval in hand. This is a historic moment for us.”
This regulatory approval gives the green light for the company to proceed with its planned market launch of Nano-Cancer® therapy, which will commence in the coming weeks.
Nanostart CEO Marco Beckmann underscored that “regulatory approval was granted not just for glioblastoma but for the treatment of all primary brain tumors, thus opening enormous market potential for the new therapy. We congratulate the management team and entire staff at MagForce on this tremendous success.”
The regulatory approval was received based on the results of a clinical study in patients suffering from recurrent glioblastoma, a particularly aggressive and deadly form of brain tumor. In these clinical trials, the new therapy was able to demonstrate its remarkable effectiveness, with median patient survival time increased from 6.2 months using conventional therapies to 13.4 months using Nano-Cancer® therapy in combination with radiotherapy. Median patient survival following diagnosis of the recurrence was thus more than doubled. Furthermore, compared to existing conventional treatments, the side effects and patient discomfort associated with the new therapy are minimal.