Proxima Therapeutics announces FDA approval of new radiation therapy system
New Hope for the Thousands of Americans Diagnosed With Brain Tumors Each Year
Proxima Therapeutics Inc., a developer and marketer of site-specific cancer treatments, today announced that its GliaSite Radiation Therapy System (RTS) treatment for brain tumors has received marketing clearance from the United States Food and Drug Administration (FDA), its first product to receive FDA approval.
The GliaSite RTS delivers site-specific, internal radiation, treating the target area while minimizing exposure to healthy tissue. The device is a balloon catheter that is inserted into the cavity created by surgical removal of the malignant brain tumor and filled with Iotrex, a proprietary liquid radiation source. Over a course of three to seven days, GliaSite delivers radiation directly to the tissue surrounding the cavity, where the tumors are most likely to recur.
The American Cancer Society estimates that 16,500 U.S. patients will be diagnosed this year with malignant primary brain tumors and nearly all will experience tumor regrowth after initial treatment. In addition, research suggests approximately 170,000 patients will be diagnosed with metastatic tumors that originate elsewhere in the body and migrate to the brain. Traditionally, patients are first treated with external beam radiation therapy, in which the radiation travels from outside the body to the tumor site, passing through healthy brain tissue. While this treatment is proven to suppress tumor regrowth, a second course of external beam radiation is rarely an option due to the high risk of damage to healthy tissue.
Until now, treatment for patients with recurrent tumors has been extremely limited. The GliaSite RTS will enable these patients to receive additional radiation, while minimizing the risks associated with external beam delivery. Additionally, GliaSite can be used in combination with external beam radiation when treating newly diagnosed tumors, and there is substantial interest in using the device in combination with surgical removal of metastatic brain tumors.
"GliaSite represents an important new treatment option for malignant brain tumors," said Stephen Tatter, MD, PhD, assistant professor of neurosurgery at Wake Forest University and lead investigator of the GliaSite study. "Radiation combined with surgery is the single most effective treatment, and GliaSite is now the best way to deliver additional radiation. The information we currently have suggests that the survival rate of the GliaSite study participants is significantly longer than the next best secondary treatment, which is chemotherapy wafers."
Safety and performance of the device were demonstrated in a National Cancer Institute (NCI)-sponsored, multi-center study, which involved patients with recurrent brain tumors. All of the patients had undergone previous surgery and radiation therapy, and just more than half of the patients had received chemotherapy. The median survival rate of the patients is currently more than 14 months, with patients still being followed, a substantial improvement over the results historically seen with other treatments.
"It's a significant advancement to be able to offer an improved therapy that delivers radiation directly to the site of the cancer, while maintaining the quality of life for patients by completing the treatment in just one week," said Dr. Tatter. "My patients and all of the other patients in the study completed treatment, and the incidence of side effects was low in comparison to other treatment options, such as chemotherapy."
"We have high expectations for GliaSite, our first product on the market," said Timothy Patrick, president and CEO of Proxima Therapeutics. "We are very encouraged by the results of the clinical trial and the response from our doctors, and we believe that GliaSite will quickly become a preferred method for treating malignant brain tumors."
GliaSite is expected to be available at licensed hospitals beginning in June. In addition to GliaSite, Proxima has developed the MammoSite RTS, a site-specific radiation treatment for breast cancer that is currently in clinical trials. Proxima's technology for breast and brain tumors also may have applications for treating other solid tumors.
About Proxima Therapeutics
Based in Alpharetta, Ga., Proxima Therapeutics, Inc. is a privately held medical device company established in 1995 to develop site-specific cancer treatment systems for breast and brain tumors. Products include GliaSite RTS for brain cancer and MammoSite RTS for early-stage breast cancer. Additional information is available on the company's website at www.gliasite.com .
Source: Proxima Therapeutics Inc.
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