First Patient Dosed in Phase 2 Trial Evaluating Ampligen-Keytruda-Chemo Combo for Ovarian Cancer

First Patient Dosed in Phase 2 Trial Evaluating Ampligen-Keytruda-Chemo Combo for Ovarian Cancer
The first patient has been dosed with Hemispherx Biopharma's experimental treatment Ampligen (rintatolimod), in combination with Keytruda (pembrolizumab) and cisplatin, for recurrent ovarian cancer. The investigator-sponsored Phase 2 trial (NCT03734692) is expected to treat 45 ovarian cancer patients who responded to platinum-based chemotherapy for at least six months. It is taking place at the University of Pittsburgh School of Medicine in Pittsburgh, Pennsylvania, and is still recruiting participants. The trial aims to test the safety and efficacy of the triple combination. Its primary goal is to determine the number of patients achieving at least a 30% reduction in tumor size. Ampligen — approved in Argentina for severe cases of chronic fatigue syndrome — is an immune modulator that activates specific immune cells and is expected to increase the number of immune cells infiltrating the tumor. Hemispherx is testing the intraperitoneal (into the abdomen) administration of Ampligen in a Phase 1/2 trial (NCT02432378). The trial's preliminary results showed that Ampligen could reprogram the tumor's microenvironment by accumulating killer T-cells — immune cells that attack cancer cells — without increasing the number of regulatory T-cells (Tregs) that suppress the immune response. "Our initial study indicates that Ampligen is generally well-tolerated via intraperitoneal administration, thus paving the way for this new Phase 2 study combining Ampligen and [Keytruda] pembrolizumab," Robert Edwards, MD, director of the ovarian cancer program at UPMC Magee-Women's Hospital and principal investigator of the trial, said in a press release. "Ampligen has the potential to be clinically significant because a robust killer T-cell population in the tumor m
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