Hemispherx Biopharma Inc. (NYSEAMERICAN:HEB) announced Monday that federal regulators will allow the company to proceed with a Phase 2 study of combining aspirin and its flagship drug ampligen to treat prostate cancer.
The study authorized by the US Food and Drug Administration will be carried out at the Roswell Park Comprehensive Cancer Center in Buffalo, New York, involving up to 60 patients, the company said in a statement.
“This positive progress in commencing a new prostate cancer clinical trial is just one more step in our focused plan for R&D success," said CEO Thomas Equels.
READ: Hemispherx sees potential commercialization of flagship drug ampligen for Chronic Fatigue Syndrome
Hemispherx says the study will investigate the effectiveness and safety of aspirin and ampligen with or without drug interferon-alpha 2b (used to treat hepatitis and cancer) compared to no drug treatments in a randomized, three-arm study of patients with prostate cancer before they undergo radical prostatectomy.
The Orlando, Florida-based biotech said aspirin may help to keep the prostate cancer from recurring, while ampligen may stimulate the immune system and interfere with the ability of tumor cells to proliferate. Interferon-alpha 2b may improve the body’s natural response to infections and may slow tumor growth.
It is not yet known how well ampligen, aspirin, and interferon-alpha 2b will work in treating patients with prostate cancer undergoing surgery, the company added.
Hemispherx is studying ampligen to treat ovarian cancer and whether the drug is effective in treating breast cancer in combination with Merck’s (NYSE:MRK) cancer drug keytruda.
Equels said the amount of clinical trials showing progress with ampligen gives the company confidence that “now is the time for us to seek out big pharma partners who share our excitement and enthusiasm for the potential of ampligen.”
Hemispherx's stocks recently trade up 3% to $0.15 a share.
Contact the author: [email protected]
Follow him on Twitter @PatrickMGraham