OCALA, Fla., May 13, 2019 (GLOBE NEWSWIRE) -- Hemispherx Biopharma Inc., (NYSE American: HEB), an immuno-pharma company focused on the research and development of therapeutics to treat multiple types of cancers and immune-deficiency diseases, announced progress toward the opening of Roswell Park Comprehensive Cancer Center’s clinical study incorporating Ampligen as part of a treatment combination for prostate cancer. Roswell Park now has FDA authorization to proceed with its Phase 2 study investigating the effectiveness and safety of aspirin and Ampligen with or without interferon-alpha 2b (Intron A) compared to no drug treatments in a randomized three-arm study of patients with prostate cancer before undergoing radical prostatectomy.
See full details of the study at ClinicalTrials.gov.
In January of this year, Roswell Park’s Institutional Review Board approved the protocol, designed by two Roswell Park faculty members, Gurkamal Chatta, MD, and Pawel Kalinski, MD, PhD, for treatment of up to 60 patients.
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. This FDA authorization to proceed sets the stage for opening enrollment in the study.
“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 Hemispherx CEO Thomas K. Equels. “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. Now is the time for us to seek out big pharma 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."
Our ongoing clinical trials:
- Phase 1 / 2 study of intraperitoneal chemo-immunotherapy in recurrent ovarian cancer at University of Pittsburgh Medical Center. Dr. R. Edwards, PI. Eleven of 12 planned patients enrolled in Stage I. See full details of the study at ClinicalTrials.gov.
- Phase 2a study of Ampligen as component of chemokine modulatory regimen on colorectal cancer metastatic to liver at Roswell Park Comprehensive Cancer Center. Dr. P. Boland, PI. Six of 12 planned patients enrolled. See full details of the study at ClinicalTrials.gov.
- Phase 2 study of metastatic triple-negative breast cancer using chemokine modulation therapy, including Ampligen and pembrolizumab at Roswell Park Comprehensive Cancer Center. Dr. M. Opyrchal, PI. See full details of the study at ClinicalTrials.gov.
- Phase 2 study of advanced ovarian cancer using cisplatin, pembrolizumab, plus Ampligen at University of Pittsburgh Medical Center. Dr. R. Edwards, PI. Up to 45 patients to be enrolled. See full details of the study at ClinicalTrials.gov.
- FDA-authorized Expanded Access Program (AMP-511) to treat ME/CFS patients.
About Hemispherx Biopharma
Hemispherx Biopharma, Inc. is an immuno-pharma company focused on the research and development of therapeutics to treat multiple types of cancers. Hemispherx's flagship products include the Argentina-approved drug rintatolimod (trade names Ampligen® or Rintamod®) and the FDA-approved drug Alferon N Injection®. Based on results of published, peer-reviewed pre-clinical studies and clinical trials, Hemispherx believes that Ampligen® may have broad-spectrum anti-viral and anti-cancer properties. Clinical trials of Ampligen® already conducted include studies of the potential treatment of cancer patients with renal cell carcinoma and malignant melanoma. These and other potential uses will require additional clinical trials to generate the safety and effectiveness data necessary to support regulatory approval and additional funding. Rintatolimod is a double-stranded RNA being developed for globally important debilitating diseases and disorders of the immune system.
Some of the statements included in this press release may be forward-looking statements that involve a number of risks and uncertainties. Among other things, for those statements, we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. Any forward-looking statements set forth in this press release speak only as of the date of this press release. We do not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. This press release and prior releases are available at www.hemispherx.net. The information found on our website is not incorporated by reference into this press release and is included for reference purposes only.
Hemispherx Biopharma, Inc.
LHA Investor Relations
Miriam Weber Miller
Senior Vice President