MagForce USA Inc., a subsidiary of German medical device company MagForce AG, is testing the effectiveness of a nanotechnology-based therapy that is believed to safely ablate prostate cancer cells.
Left to right: Ian Thompson Jr., MD, and Ian Thompson III, MD
Current treatment methods for early stage prostate cancer are highly effective. However, they often come with lifelong side effects. For many patients, the benefits of treatment simply do not outweigh the risks.
MagForce, a leader in the field of oncology nanomedicine, hopes to alleviate some of the concern about risk by bringing its proprietary NanoTherm therapy to the mainstream as a treatment for low- to medium-risk prostate cancer.
“There is no doubt that focal therapy will play a role in the future of prostate cancer treatment, as MagForce is providing a new, alternative method for the ablation of prostate cancer. The innovative clinical trials we are starting here in San Antonio could have global implications in regards to prostate cancer care.”
— Michael Liss, MD, urologist at UT Health San Antonio and Principal Investigator for MagForce USA Inc.
The Status Quo
There are currently three primary methods of responding to prostate cancer: surgery, radiation and active surveillance. Patients with low- to medium-risk prostate cancer — defined as having a prostate-specific antigen (PSA) level of 20 ng/ml or lower, a Gleason score of 7 or lower and a tumor state of T1, T2a or T2b — have a high chance of being cured with either surgery or radiation. Unfortunately, either treatment option may result in significant side effects.
With surgery, for instance, patients may experience pain, bleeding or infection during the procedure. Afterward, the patient may experience potentially long-term urinary incontinence and erectile dysfunction. There is also the potential, albeit low, risk of death associated with prostate surgery. Radiation therapy might lead to urinary obstruction or incontinence, erectile dysfunction and bowel problems, such as diarrhea or rectal bleeding.
These side effects, in combination with the often slow-growing nature of prostate cancer, lead many patients with low- to medium-risk prostate cancer to opt for active surveillance, the close monitoring of the cancer’s growth. This choice, however, can leave patients vulnerable.
“We increasingly see patients with low-grade, low-volume prostate cancer managed with active surveillance and patients with high-grade, high-volume prostate cancer managed with multimodal therapies,” says Ian Thompson Jr., MD, a partner with Texas Urology Group and President at CHRISTUS Santa Rosa Hospital - Medical Center and Principal Investigator for MagForce USA Inc. “There is a group of medium-risk patients in between, however, for whom we really do not have an optimal therapy. On active surveillance, those patients tend to do well, but there is a 10 to 20 percent chance of mortality within 10 to 15 years. That is unacceptable.”
“Ablation therapies, such as NanoTherm therapy, reduce the risk of overtreatment and make the argument for PSA testing that much stronger. With this technology, you can effectively sort out tumors that do not need to be treated, aggressively treat high-risk tumors and potentially ablate those intermediate-risk tumors that could later lead to death.”
— Ian Thompson Jr., MD, President at CHRISTUS Santa Rosa Hospital-Medical Center and Principal Investigator for MagForce USA Inc.
Fighting Cancer With Nanotechnology
Andreas Jordan, PhD, Executive Vice President of MagForce USA Inc. and Founder of MagForce AG, invented NanoTherm therapy after years of researching the potential use of nanotechnology-based cancer treatments.
The therapy involves inserting NanoTherm, a liquid containing iron oxide nanoparticles with a special silica coating, directly into the tumor. The nanoparticles are then exposed to a rapidly alternating magnetic field inside the NanoActivator device (similar to an MRI machine). The device raises the temperature inside the target area to 55˚ C (or 131˚ F) for 60 minutes.
“To ablate the cancer cells, we have to focus heat onto the tumors so that no healthy tissue is harmed,” Jordan says. “We believe the precision of treatment is so advanced that we can protect the structures and organs in the body and have extremely low adverse effects.”
NanoTherm was first approved in the European Union in 2011 as a treatment for a type of brain cancer. Used in conjunction with radiation, it was found to increase glioblastoma multiforme patients’ life expectancy after diagnosis from between eight and 16 months to a median of 26 months.
MagForce is now seeking FDA approval for the use of this nanotechnology-based therapy as a treatment option for prostate cancer patients in the U.S.
“NanoTherm therapy fits into the treatment paradigm if a patient diagnosed with low- to medium- risk prostate cancer is on active surveillance and his tumor begins to seem riskier. We could inject these nanoparticles and ablate the tumor,” says Ian Thompson III, MD, owner of Texas Urology, Chief Medical Officer of CHRISTUS Santa Rosa Hospital-Medical Center and Principal Investigator for MagForce USA Inc. “After treating patients with NanoTherm therapy, we would hypothetically be able to safely return them to active surveillance and avoid the long-lasting side effects that come with either surgery or radiation.”
Testing a New Treatment Path
The three-part clinical trials are currently being conducted at two clinical centers. The first is in San Antonio, and its principal investigators are Dr. Thompson Jr., Dr. Thompson III and Michael Liss, MD, urologist at UT Health San Antonio. The second center is in Seattle, and its principal investigator is Daniel Lin, MD. MagForce will add a third site, in Sarasota, Florida, in time for the later stages of the trials.
“The only way to get this technology on the market is by getting people enrolled in the studies so we can fulfill the FDA requirements,” says David Hammond, Clinical Trials Director for MagForce USA Inc. “We need more subjects to get to that stage.”
Participants in the trial must be between ages 40 and 85 and have biopsy-confirmed prostate cancer. They also must not have had previous cancer treatments involving radiation, androgen deprivation or surgery; be in a concurrent clinical trial for prostate disease; have metallic implants below the neck; have an active urinary tract infection, significant prostate systems (I-PSS score greater than 20) or a hematological abnormality; or have a known hypersensitivity to the imaging agent used to detect and localize prostate cancer.
Participants in the first phase of the clinical trials must also be planning to undergo radical prostatectomy; this surgery will be performed after the NanoTherm therapy takes place. This allows MagForce to evaluate the prostate pathologically and determine if the NanoTherm therapy was able to ablate the cancer cells without harming the surrounding tissue.
For patients who are unable to pay for surgery, MagForce provides financial coverage for the treatment.
“If we have a potential subject who does not have health insurance or is not completely covered by his insurance, he can rest assured that we will cover all of the out-of-pocket costs of the prostatectomy,” Hammond says. “That is in addition to transportation and hotel costs if they have to stay overnight.”
For the second and third phases of the clinical trials, MagForce will focus on participants who do not require a prostatectomy. Rather than having the whole prostate removed, participants will instead receive a biopsy five and 12 months after receiving NanoTherm therapy to see if the ablation was effective.
“We at MagForce USA are very pleased to have the opportunity to conduct this important clinical trial with such outstanding urologists, such as Dr. Thompson Jr. and Dr. Thompson III of the Texas Urology Group and Dr. Liss of UT Health San Antonio. Our collective goal is to focally ablate identified prostate lesions using unique nanoparticles placed within the lesion. We plan for this study to show that we effectively ablate and have minimal side effects. We expect the clinical trial will prove that NanoTherm therapy will allow men diagnosed with intermediate-risk prostate cancer to have a higher quality of life, while delaying or even avoiding definitive treatments.”
— Dr. Ben Lipps, CEO of MagForce USA Inc.
The Future of Cancer Treatment
If approved, NanoTherm therapy will offer men an active treatment that may potentially have fewer risks and side effects.
“It has the potential to significantly change the way we treat prostate cancer, because it allows for a less invasive, less aggressive treatment modality that could cure the cancer or, at a minimum, reduce a patient’s chances of needing a more aggressive treatment in the future,” Dr. Thompson III says. “About 30,000 men die of prostate cancer every year. With NanoTherm therapy, we hope we can continue to reduce those numbers while avoiding the cost of surgery or radiation for some of those men.”
While the implications of these trials are vast, Jordan says treating prostate cancer is only the first step. As evidenced by its use in the European Union as a treatment for brain cancer, NanoTherm therapy has the potential to treat other forms of cancer, as well.
“We are starting with focal ablation therapy in the U.S. from a base of years of clinical experience and studies on the effectiveness of nanotechnology-based therapy against multiple types of cancer,” Jordan says. “NanoTherm therapy can be used to treat any localized tumor regardless of its location, because the magnetic field has no limitations. As with radiation, it has the potential to be used universally.”
For more information about MagForce, call 833-287-1150 or visit magforcestudy.com.