For Germany's MagForce, a step back before moving forward with its nanoparticle tumor treatment

BERLIN--Two interconnected spherical buildings straight out of "The Jetsons" sit in a high-tech industrial park in southeastern Berlin, relics from the 1950s and 1960s when the East German Academy of Science conducted aerodynamics research here.

Those buildings are now on the edge of a high tech district, with blocks of media, biotech, med tech and other companies in super-modern, low-rise office buildings. Within one of them, at Max-Planck Strasse 3, MagForce AG is plotting its second coming.

The Berlin- and Munich-based company, founded in 1997 and publicly traded on the Frankfurt Stock Exchange since 2007, has a unique place in the device world with its NanoTherm Therapy--CE marked since 2010 to fry tumors from the inside out.

How it works: A neurosurgeon injects microscopic, magnetic, coated superparamagnetic nanoparticles directly into a brain tumor, where fluid agglomerates, and the particles lie dormant due to their special coating. Next, doctors use the company's NanoPlan software to develop a simulated treatment plan, taking into account tumor size and location, in addition to locations of the NanoTherm particles. And then the patient is run through the Nanoactivator, a device resembling an MRI machine, generating alternating magnetic fields changing polarity 100,000 times per second. The NanoTherm particles oscillate and generate heat and as a result, either burn the tumor away (thermoablation) or make the cells more vulnerable to radiation or chemotherapy. The process involves six treatments in the Nanoactivator after the initial particle injection, which is done only one time.

Hoda Tawfik

But the device hasn't yet found its market. And so MagForce has taken a step back to regroup and try again. Co-CEOs Dr. Hoda Tawfik and Christian von Volkmann told me during an interview at MagForce's Berlin offices that the company's plans are advancing steadily, after nearly 2 years of reorganization, fund-raising and careful planning of how to move forward. (Tawfik is also MagForce's chief operating officer, and von Volkmann its CFO.)

One major obstacle they identified: Even though NanoTherm is a device and not a drug, it is also a therapeutic. Oncologists traditionally use drugs to attack tumors, and drug approval processes are far more rigorous than devices. And so the medical community--neurosurgeons and radiation oncologists--remains cautious about turning to the ambitious device to treat glioblastoma tumors.

"Although the company got a CE mark approval as a medical device, it didn't get any acceptance in the oncology community," Tawfik said during our conversation.

One reason for this: there was limited human clinical data available involving less than 100 patients in two small trials that helped support the CE mark. To compete with drug therapeutics, it needed similar, compelling data from a wider patient sample, just as a drug might obtain. They will get that now, as MagForce is gearing up for a sizeable, 280-patient post-marketing trial set to start in September, initially in Germany but then expanded to Europe and possibly the U.S. Tawfik said the company has consulted with "key opinion leaders" to design and set up the post-marketing study, which will focus on recurring glioblastoma. And that extra data can help promote expanded adoption down the line. (Other tests are planned or under way to use the therapy to address prostate and pancreatic cancer.)

Another issue: MagForce's funding has been smaller scale since its start. Executives raised just 5.8 million euros in the early 2000s, another 5 million euros in 2010, and so on. Because the company's new leadership viewed larger scale clinical testing as helping to promote wider adoption, they needed the money to get the job done. So MagForce raised 33.3 million euros to that end, in March 2013.

Christian von Volkmann

"When I joined last year, I talked to [co-CEO Tawfik] and realized the company needed financing badly," von Volkmann told FierceMedicalDevices. "The focus in the company wasn't so much on commercialization but on research. We decided this should change." Von Volkmann noted that of the 33.3 million (euros) raised, 17.5 million involved a debt to equity swap. The investor interest helped MagForce eliminate its debt, and he said the response showed "the strategy was right."

MagForce is also now contemplating its U.S. approval strategy. The company hopes to submit its application for a pre-PMA meeting with the FDA within the next month. The agency could grant PMA approval based on data already out there. Or it may seek more data, for which the company's post-marketing study could also come in handy.

"There are a lot of options," Tawfik said. -- Mark Hollmer (email | Twitter)

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