SAN JOSE, Calif. (January 6, 2014) — Verthermia Inc. announced that the U.S. Food and Drug Administration (FDA) has approved the Company’s application to begin a Phase I clinical trial exploring the potential of whole body hyperthermia as a standalone cancer treatment for women with Stage III or IV ovarian cancer. The study is the Company’s first cancer therapy approved for clinical trials by FDA, treating late stage solid-tumor cancers.
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.
The trial design calls for 20 patients to receive one cycle of treatment monthly for six consecutive months. The trial is expected to last approximately 24 months, including enrollment, treatment, and long-term patient follow-up.
“We are very pleased with the recent news and what it could mean to women suffering from late stage ovarian cancer, a disease in which very little progress has been made.” said Verthermia President and CEO Dr. Roger Vertrees.
ClinicalTrials.gov identifier “NCT02093871”. The study is currently being conducted in San Jose, Calif.