BERLIN, GERMANY - Fresh off our Puerto Rican adventure, last week FierceMedicalDevices visited the Berlin-Bradenburg area, one of Europe's top regions for biotech. Roughly 200 biotechs and 20 pharma companies conduct research there, according to BioTOP Berlin Brandenburg, which coordinates regional activities in biotechnology.
Germany's capital boasts a number of innovative biotech and medical device companies, including a promising nanomedicine firm called MagForce, which is looking to help patients with solid tumors. This past June, the company received CE marking for Nano-Cancer therapy to treat glioblastoma multiforme (GMB), a highly aggressive type of brain tumor.
FMD spoke with Stacy Wiedenmann, director of investor relations and corporate communications at MagForce, while in Berlin. She told FMD that the company is looking to establish its Nano-Cancer therapy as an additional pillar in cancer treatment beyond surgery, radiotherapy and chemotherapy.
Drug and devicemakers alike have been looking for ways to treat GBM, a very aggressive disease with an incidence of 26,000 new cases annually in the U.S., Japan, Germany, France, the U.K., Italy and Spain. There have been no significant survival improvements in the last 20 years. Recently, the NIH awarded the Case Comprehensive Cancer Center a $2.5 million grant from the National Cancer Institute to evaluate the introduction and expression of the modified MGMT gene in hematopoietic stem cells to improve efficacy of chemotherapy for GBM. And Peregrine Pharmaceuticals just completed of enrollment in the company's Phase II dose confirmation trial of Cotara in patients with recurrent GBM.
But MagForce has an intriguing approach with its Nano-Cancer therapy, which works by enabling the targeted treatment of solid tumors through the intratumoral release of heat from magnetic nanoparticles. The therapy consists of three components: the NanoTherm nanoparticles, the NanoPlan therapy planning software and the NanoActivator magnetic field applicator, where the nanoparticles are actually heated. The nanoparticles are injected into the tumor, and, because of their special coating, aggregate in place, allowing for repeated treatments. Next, Wiedenmann explained, the tumor is basically heated from the inside out. During the heating procedure, which lasts about an hour, the patient is comfortable, Wiedenmann said, and experiences only minor side effects like sweating. Patients are treated for three weeks, two times a week.
Depending on the temperature reached and length of treatment, the tumor cells are either directly destroyed or sensitized for the accompanying chemotherapy or radiation. In studies, patients treated with Nano-Cancer and accompanying radiotherapy, the median survival time following diagnosis of the first tumor recurrence was 13.4 months, compared with the 6.2-month median survival time following recurrence observed in an EORTC study.
The products used in the therapy, NanoTherm and NanoActivator, have received EU-wide regulatory approval as medical devices for the treatment of brain tumors, but MagForce hopes to eventually show the therapy is effective in any type of solid tumor. Moving forward, the company wants to establish Germany as a reference market. Not a lot of key opinion leaders know much about the therapy, Wiedenmann explained. The company hopes to change this and use data from clinical studies to gain approval for additional indications.
MagForce is anticipating to roll out the product in Germany and one additional European company next year. It also is interested in partnering and licensing agreements for eventual commercialization in the rest of the world. Wiedenmann says the company has strong financial resources and will need additional funding for any clinical studies required for regulatory approval in the U.S., where it does not yet have clearance.
MagForce was founded in 1997 and has 27 direct employees and an additional 18 at its subsidiary MT MedTech Engineering. It is listed on the Frankfurt Stock Exchange. - Liz Jones Hollis (email | twitter)