The U.S. Food and Drug Administration (FDA) approved the company’s application to conduct the study, which began in January. The trial is the company’s first cancer therapy the FDA has approved for clinical trial and it is in the safety phase of studying the treatment of late-stage solidtumor cancers. Verthermia is actively recruiting patients as the initial study is expected to last approximately two years.
According to Verthermia’s CMO and the HEATT trials Principal Investigator, Dr. James F. Lilja, the eClinicalOS platform is a perfect fit for the study, which incorporates a range of data collection and monitoring processes. "Data integrity is a top priority for a critical trial, and we saw Merge eClinical as an ideal partner in helping us complete Phase I and beyond. Our goal is to make Whole Body Hyperthermia a safe ‘fourth modality’ of cancer treatments. Safe outcomes with data to measure them are the keys to our success."
Dr. Lilja also noted the eClinicalOS platform’s unique design allowed the Verthermia team to build and launch the study in just three weeks. "That kind of start-to-go-live time means we can bring potentially life-saving treatment more quickly not only to study participants now, but also to other severely ill patients in the future if we’re successful," he said. "We are committed to improving the outcomes of Stage III and IV ovarian cancer patients and see partners like Merge eClinical as critical to our success."
Merge eClinical President Zaher El-Assi said his company is honored to be a part of Verthermia’s work. "Our goal is for eClinicalOS to be the standard clinical data management platform no matter a study’s size, phase, complexity or location," he said. "In talking with the
Verthermia research team, it was clear they needed a fully integrated, end-to-end study management platform that was also sophisticated, intuitive and cost effective. They also needed a platform that could get the study up and running in weeks, not months, as well as one that didn’t require steep upfront costs. That’s eClinicalOS in a nutshell."
The study is designed to raise a patient’s core temperature to therapeutic range via the CoreHFC™ medical device, maintaining that temperature, detoxifying the blood and returning the patient to normal body temperature. As proven by past studies, a key advantage of regional and whole body hyperthermia is that it helps other forms of cancer treatment work better because heating cancer cells to temperatures above normal makes them easier to destroy using radiation and certain chemotherapy drugs.