Hemispherx Announces New Data Showing Ampligen’s Positive Role in Reprograming Tumor Microenvironment

Study Results Suggests Ampligen Could Materially Enhance the Effectiveness of Checkpoint Blockade Technology

ORLANDO, Fla., June 05, 2018 (GLOBE NEWSWIRE) -- Hemispherx Biopharma, Inc. (NYSE American:HEB) announced today that its TLR3 agonist Ampligen outperformed two other TLR3 agonists, poly IC and natural double stranded RNA, in creating an enhanced tumor microenvironment for checkpoint blockage therapy. Hemispherx is an advanced specialty pharmaceutical company engaged in the treatment of serious and debilitating disorders.

In a head-to-head study in explant culture models, Ampligen activated the TLR3 pathway and promoted an accumulation of killer T cells but, unlike the other two TLR3 agonists, it did so without causing regulatory T cell (Treg) attraction. These findings are considered important because they show that Ampligen selectively reprograms the tumor microenvironment by inducing the beneficial aspects of tumor inflammation (attracting killer T cells), without amplifying immune suppressive elements such as regulator T cells. The study, conducted at the University of Pittsburgh and Roswell Park Comprehensive Cancer Center, as a part of the NIH-funded P01 CA132714 and Ovarian Cancer Specialized Program of Research Excellence (SPORE), was published online in the journal Cancer Research (http://cancerres.aacrjournals.org/content/early/2018/05/31/0008-5472.CAN-17-3985).

“This has the potential to be clinically significant because a robust killer T cell population in the tumor microenvironment without attraction of Treg cells is important to help optimize checkpoint blockade-induced tumor shrinkage.” said Robert P. Edwards MD, executive vice chair of gynecologic services at Magee-Womens Hospital of UPMC and Professor of Obstetrics, Gynecology & Reproductive Services, University of Pittsburgh School of Medicine.

Lead investigator Pawel Kalinski, MD, PhD, Vice Chair for Translational Research and Professor of Oncology, Department of Medicine at Roswell Park, commented that the study “provides a strong foundation for moving forward with solid tumor studies to clinically demonstrate the extent to which Ampligen reprograms the tumor microenvironment in various clinical settings, with the goal of developing more effective immune therapies with checkpoint blockers.”

“We believe this is a valuable survival-enhancing medical strategy, building on the known capability of immuno-oncology agents such as Keytruda and Opdivo and potentially giving them a significant boost in tumor killing activity” said Thomas K. Equels, Chief Executive Officer of Hemispherx.

About Hemispherx Biopharma
Hemispherx Biopharma, Inc. is an advanced specialty pharmaceutical company engaged in the clinical development of new drug entities for the treatment of serious and debilitating disorders. Hemispherx's flagship products include the FDA-approved drug Alferon N Injection® and the Argentina-approved drug rintatolimod (tradenames Ampligen® or Rintamod®). Rintatolimod is a double-stranded RNA being developed for globally important debilitating diseases and disorders of the immune system, including Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS). Hemispherx's platform technology includes components for the potential treatment of various severely debilitating and life-threatening diseases. Because rintatolimod has not been designated safe and effective by the FDA for general use, it is legally available in the United States only through clinical trials; however, Ampligen® has been approved in Argentina for severe ME/CFS. The company is working toward legal access in other countries where early access programs exist for serious diseases, such as ME/CFS, with unmet medical needs. Ampligen® is the only therapy approved anywhere in the world for ME/CFS. An Ampligen® EAP approval has also been obtained for therapeutic use in the Netherlands for pancreatic cancer.

Cautionary Statement
Some of the statements included in this press release may be forward-looking statements that involve a number of risks and uncertainties. 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.

Contact
Hemispherx Biopharma
Phone Number: 800-778-4042
Email: IR@hemispherx.net

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