Tempe, Ariz.-based Gt Medical Technologies Inc. has won the U.S. FDA’s nod for an expanded indication for Gammatile therapy. With this decision, patients with newly diagnosed malignant brain tumors now are eligible to receive the FDA-cleared surgically targeted radiation therapy.
Matthew Likens, president and CEO of Gt Medical, noted that the company was excited to offer the therapy to those who are newly diagnosed with malignant brain tumors. Previously, the therapy was available for individuals with recurrent ones.
“Patients receiving Gammatile therapy immediately after the removal of a brain tumor will have the peace of mind that they are accelerating their radiation treatment and targeting residual tumor cells where treatment is most needed to help prevent recurrence,” he added.
Gammatile therapy offers an option vs. waiting several weeks for surgical wound healing before beginning treatment. It protects healthy brain tissue while delivering a targeted dose to any remaining tumor cells. In addition, it limits certain side effects, such as hair loss.
"The neurosurgeon is handed these tiles by the radiation oncologist. They're literally tiling the inner wall of the cavity and the base of the cavity and then closing the patient up," Likens told BioWorld last year. "It's a five-minute procedure right at the end of the resection process." As a result, it does not disrupt the workflow of the operating suite.
With this indication in hand, this new group of patients will not have to wait long for treatment. “Patients will be eligible to receive Gammatile therapy immediately at the 15 centers where the treatment is currently available,” Likens told BioWorld.
When asked about other markets, he noted that the U.S. remained the company’s immediate focus. “[B]ut we consider Gammatile to be a global technology, and we plan to deploy it outside the U.S. in the future.”
Looking to improve the space
The company placed the number of people in the U.S. living with some type of brain tumor each year at roughly 700,000, citing figures from the American Brain Tumor Association. It also noted that despite the attempts by surgeons, outcomes for patients with brain tumors have not improved very much over the past 30 years. The FDA has approved four drugs and cleared two devices in that time period to help these patients. Now, Gammatile looks to advance the field and is the most recent treatment cleared or approved.
“Approximately 400,000 Americans are newly diagnosed with some type of brain tumor each year, including gliomas, meningiomas and brain metastases,” Likens told BioWorld. “This expanded indication more than triples the number of patients who can benefit from Gammatile therapy.”
In a clinical study, Gammatile therapy gave the average patient about an extra 10 months without a local recurrence with extended overall survival. Clark Chen, head of the Department of Neurosurgery at the University of Minnesota Medical School, presented data from his first patients treated with Gammatile at the 2019 Society of Neuro-Oncology Annual Meeting.
Consistent with data published in a peer-reviewed article, Chen noted that local control was achieved in about 90% of patients who underwent gross total resection. This result was achieved without an increase in wound complications or length of hospital stay.
For his part, Vincent DiNapoli, neurosurgeon and director of the Brain Tumor Center at The Jewish Hospital in Cincinnati, has been treating patients with Gammatile therapy since August 2019. “Having been encouraged by the outcomes for recurrent brain tumor patients treated with Gammatile therapy in my practice, I am excited by the FDA’s decision to expand this technology to the many patients who can benefit from the treatment during their initial diagnosis,” DiNapoli said. “This could potentially create a more meaningful impact on patient outcomes, treatment compliance, and quality of life.”
Patients also have been enthusiastic, as they have not had to come back for repeated hospital visits.
Working with Isoray
Gt Medical and its collaborator Isoray Inc., of Richland, Wash., reported July 9, 2018, the receipt of FDA clearance of Gammatile therapy for the treatment of recurrent brain tumors. In January 2018, Isoray revealed the signing of an exclusive manufacturing and supply agreement with Gt Medical for Cesium-131 seeds embedded in the product’s collagen tiles. The term of the agreement was 10 years.
For its part, during its Nov. 12, 2019, first-quarter earnings call, Isoray CEO Lori Woods discussed the potential for the now-realized expanded indication for Gammatile. “We are very interested in how this effort for expanded indication proceeds with the FDA because of its implications for Cesium-131 and Isoray,” she said. She noted that the product remained in active review, with revenues for Gt Medical remaining nominal as the company continued to introduce the Gammatile centers around the U.S.
$10M series A
The news regarding the FDA’s decision comes about a year after the company reported that it had raised $10 million in a series A financing to support the commercialization of Gammatile therapy.
At the time, Likens said his company had the intellectual property for use of the therapy in extra-cranial applications, but due to its resources, it planned to concentrate totally on the brain for the immediate future.
“Gammatile therapy was specifically designed with the brain’s delicate environment in mind and our current focus is on improving the lives of patients with brain tumors,” told BioWorld in the wake of the expanded clearance. Because of its IP protection beyond the brain “we are currently collecting feedback on other potential indications for the future,” Likens concluded.