FDA OKs Phase 2 Trial of Ampligen Combo as Pre-surgery PC Treatment

The U.S. Food and Drug Administration (FDA) has authorized the initiation of a Phase 2 clinical trial testing Hemispherx Biopharma‘s Ampligen (rintatolimod), in combination with aspirin or aspirin plus Intron A (interferon-alpha 2b), as a treatment for prostate cancer patients before surgery.

The randomized clinical trial (NCT03899987) will be carried out at Roswell Park Comprehensive Cancer Center in Buffalo, New York. It plans to include 60 participants.

Ampligen — approved in Argentina for severe cases of chronic fatigue syndrome — is an immune modulator that activates specific immune cells that attack cancer cells and increases the number of immune cells that infiltrate the tumor, thus affecting its ability to grow and spread.

The trial will combine this therapy with aspirin, which is expected to prevent cancer from coming back after surgery, with or without Intron A. The trial will include a third group of patients who will receive surgery without any treatment beforehand.

Intron A is a lab-made version of a human interferon — small proteins naturally produced by the body in response to infections — and is expected to improve patients’ response to infections and hinder tumor growth.

The trial’s main goal is to assess the immune composition of the tumor, including immune cells and signaling molecules. Secondary measures include safety and preliminary efficacy measures.

“This positive progress in commencing a new prostate cancer clinical trial is just one more step in our focused plan for R&D success,” Thomas K. Equels, Hemispherx’s CEO, said in a press release.

“When our management team began three years ago, Hemispherx identified four significant steps we needed to take to make our company a success. First, raise the funds necessary to produce our drug candidate, Ampligen, for use in immuno-oncology clinical trials and other programs. Second, produce adequate supplies of Ampligen to conduct such trials. Third, initiate multiple immuno-oncology clinical trials. We have now accomplished each of these steps and are using Ampligen to treat cancers in clinical trials,” he said.

“Now is the time for us to seek out big [pharmaceutical] partners who share our excitement and enthusiasm for the potential of Ampligen. We believe that success in these trials will create the environment for that goal. Accomplishing success in R&D is based on such progress.”

Ampligen is also being tested in combination with various anti-cancer therapies in four Phase 1 and Phase 2 clinical trials treating people with ovarian cancer, colorectal cancer, and breast cancer.