A new investigator-sponsored clinical trial is recruiting women with recurrent, platinum-sensitive ovarian cancer to study a combination of Hemispherx Biopharma’s investigational product Ampligen (rintatolimod) plus chemo-immunotherapy, the company announced.
The Phase 1/2 trial (NCT03734692) is being conducted at the UPMC Hillman Cancer Center in Pittsburgh, Pennsylvania, under the supervision of Robert Edwards, MD, director of the Ovarian Cancer Program at UPMC Magee Womens Hospital.
It is expected to enroll up to 45 adult women who received one or two prior treatments, and responded to platinum-based chemotherapy for six months or longer.
“At Hemispherx we are determined to pursue a comprehensive R&D program focused on improved immune therapies for lethal malignancies such as recurrent ovarian cancer,” Thomas K. Equels, CEO of Hemispherx, said in a press release.
“We believe this clinical study at UPMC is an important step in Hemispherx’ overall clinical plan in immuno-oncology and just one of the major milestones we have recently announced,” he said.
Combination of anti-cancer agents is based on the idea that they can work together to fight cancer. Chemotherapy and immunotherapies such as Merck’s Keytruda (pembrolizumab) have shown promise in fighting ovarian cancers, but their activity can be boosted by increasing the amount of immune cells infiltrating the tumors.
Ampligen — approved in Argentina for severe cases of chronic fatigue syndrome — is an immune modulator that activates part of the immune system and is thought to facilitate immune infiltration within tumors. Adding Ampligen to chemo-immunotherapy is thought to give an additional advantage to the immune system in the fight against ovarian cancer.
In preclinical studies, Ampligen has shown synergy with other cancer treatments in animal models. Data from human tumors indicate this effect could be extended to patients.
“We believe the expected synergy with the checkpoint inhibitors in humans has the potential to position Ampligen as a medical translational breakthrough in immuno-oncology,” Equels said.
In the ongoing trial, participants will receive a combination of Keytruda, the chemotherapeutic agent Platinol (cisplatin), and 200 mg Ampligen. Treatment will be given in six three-week cycles, but approximately four weeks after the fourth treatment cycle, patients will undergo surgery to remove the residual tumor. The remaining two cycles will consolidate tumor clearance.
The trial aims to determine the number of patients achieving at least a 30% reduction in tumor size; secondary measures include the time to disease worsening or death, and changes in immune T cells in the tumor and its environment. For more information, click here.