Hemispherx BioPharma (HEB)

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Significant_Progress_in_its_Ampligen_Ovarian_Cancer_Program_Hemispherx (AMEX:HEB)

Today : Tuesday 30 April 2019

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(NYSE American: HEB) — Hemispherx Biopharma Inc., an immuno-pharma company focused on the research and development of therapeutics to treat multiple types of cancers, announced today significant progress in its Ampligen recurrent ovarian cancer program at the University of Pittsburgh Medical Center (UPMC) under the leadership of the principal investigator, Robert Edwards, MD. The ovarian cancer program is being funded in part by an Ovarian Cancer Specialized Program of Research Excellence (SPORE) from the National Institutes of Health (NIH), which is supporting a Phase 1/2 study of intraperitoneal chemo-immunotherapy in recurrent ovarian cancer.
Recently, an interim report was received by Hemispherx that summarizes results related to some of the laboratory objectives of this study which include characterization of the local immune responses during chemo-induced cell death as measured by serial assessment of peritoneal fluid cellular phenotypes and chemokine patterns.

"Ampligen has the potential to be clinically significant because a robust killer T-cell population in the tumor microenvironment without attracting Treg cells is important to help optimize checkpoint blockade induced tumor shrinkage," said Dr. Edwards, chair of gynecologic services at Magee-Women’s Hospital of the University of Pittsburgh School of Medicine (UPMC), Professor of Obstetrics, Gynecology & Reproductive Services at UPMC, a world-class expert in ovarian cancer and a pioneer in Ampligen research.

Currently, a second ovarian cancer clinical trial at UPMC is beginning to accrue patients. This is a Phase 2 investigator-sponsored trial fully funded by an industry grant that will evaluate Ampligen in combination with the checkpoint blockade drug, pembrolizumab. This much larger trial will test the combination of Ampligen and pembrolizumab in subjects with advanced recurrent ovarian carcinoma. For more details regarding the collaboration and protocol, please go to the NIH-sponsored website, https://clinicaltrials.gov/ct2/show/NCT03734692.

“Ovarian cancer is projected to kill 152,000 this year worldwide. Recurrent ovarian cancer is a dire unmet medical need. Working with the University of Pittsburgh, we are able to team up and focus world-class science on developing a meaningful combination therapy with the potential to save the lives of women who may be out of therapeutic options,” declared Thomas K. Equels, CEO of Hemispherx.

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.

Cautionary Statement

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.

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Miriam Weber Miller
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