LOS GATOS, Calif., Nov. 6, 2014 (GLOBE NEWSWIRE) -- Verthermia, Inc. has selected the Merge eClinicalOS data management platform from Merge eClinical for its clinical trial exploring the potential of whole body hyperthermia as a standalone treatment for women with Stage III or IV ovarian cancer.
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 solid-tumor 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.
To learn more about the Verthermia study, a patient or her physician may review the website (www.verthermia.com) or contact the Verthermia study research staff (below) using the ClinicalTrials.gov identifier "NCT02093871." The study is currently being conducted in San Jose, Calif.
- James F. Lilja, MD: 408.827.4274
- Heather McAvoy, LVN: 408.827.4274 ext. 5 – Heather@bayareago.com
Verthermia Inc. was formed in 2012 to further develop whole-body hyperthermia as the fourth modality in the treatment of cancer. The company received FDA clearance to begin a Phase I women's ovarian cancer safety trial that began in January of this year. The company's team of specialists in gynecologic & surgical oncology, nephrology, and perfusion serve as collaborators for the clinical trials and all subsequent clinical work. More information at www.verthermia.com.
About Merge eClinical
Merge eClinical is a division of Merge Healthcare, Inc. (Nasdaq:MRGE), a leading provider of clinical systems and innovations that seek to transform healthcare. eClinicalOS, the company's flagship product, is a single, scalable cloud-based platform researchers can configure to suit a study's precise needs. From monitoring inventory and managing randomization to endpoint adjudication and archiving results, users pay only for the options they use. Studies built within eCOS can launch in as few as 10 days, and the average deployment time from project initiation is 40 days. More information is available at www.eclinicalos.com.
Merge is a leading provider of innovative enterprise imaging, interoperability and clinical systems that seek to advance healthcare. Merge's enterprise and cloud-based technologies for image intensive specialties provide access to any image, anywhere, any time. Merge also provides clinical trials software with end-to-end study support in a single platform and other intelligent health data and analytics solutions. With solutions that have been used by providers for more than 25 years, Merge is helping to reduce costs, improve efficiencies and enhance the quality of healthcare worldwide. For more information, visit merge.com and follow us at @MergeHealthcare.
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