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Hemispherx Announces Dutch Health Inspectorate Approval to Extend the Ampligen Pancreatic Cancer Early Access Program Until March 2020

1216 Days ago

OCALA, Fla., Feb. 28, 2019 (GLOBE NEWSWIRE) -- (NYSE American: HEB) — Hemispherx Biopharma, Inc. (NYSE American: HEB), an immuno-pharma R&D and emerging commercial growth company focused on unmet medical needs in immunology, announced today the extension of its Early Access Program (EAP) at the Erasmus Medical Center in the Netherlands using its drug Ampligen in the treatment of pancreatic cancer. The EAP is approved by the Dutch Health Inspectorate until March 9, 2020 to treat pancreatic cancer patients diagnosed with any stage of the serious disease. The patients receive Ampligen as a maintenance therapy after completing standard care.

Approximately 459,000 people globally with 55,000 in the U.S. are diagnosed each year with pancreatic cancer, and it causes approximately 430,000 deaths worldwide and 44,000 in the U.S. according to the Cancer Research Institute (https://www.cancerresearch.org/immunotherapy/cancer-types/pancreatic-cancer). The long term survival rate for the disease is 7%. The incidence of pancreatic cancer is estimated to increase to approximately 815,000 worldwide in 2040; an increase of approximately 78% (http://gco.iarc.fr/tomorrow/graphic-isotype?type=0&population=900&mode=population&sex=0&cancer=39&age_group=value&apc_male=0&apc_female=0). 

In an abstract presented at the Pancreas Club 2018 Annual Meeting [https://www.pancreasclub.com/wp-content/uploads/2018/06/Poster-Abstracts.pdf, see poster P. 66, pages 40-41], clinicians at Erasmus announced results on 26 pancreatic cancer patients treated with Ampligen maintenance therapy. The clinicians stated “According to the response evaluation criteria in solid tumors, 5 patients showed stable disease and 2 patients showed regression of metastases during Ampligen treatment.” They concluded … “Ampligen could induce an immune response and in addition a beneficial shift in the NLR and SII” (NLR = neutrophil-to-lymphocyte ratio; SII = systemic inflammation index). This program has continued to treat pancreatic cancer patients with Ampligen. Currently, 43 patients have been treated with Ampligen in this program. “We are grateful for the groundbreaking work done by the clinicians at Erasmus and are committed to the goal of helping patients with this deadly disease” says Thomas K. Equels, chief executive officer at Hemispherx.

Hemispherx is dedicated to evaluating Ampligen for the potential treatment of pancreatic cancer patients, especially in combination with checkpoint blockade therapies. An initial preclinical study of pancreatic cancer in a mouse model combining Ampligen with an anti-PD-L1 drug showed a significant synergistic increase in median survival over control (p=0.029). This experiment, which was conducted at the University of Nebraska, is now planned to be extended using larger tumors in the animal pancreatic cancer model and by studying the activity of Ampligen when combined with anti-PD-1, as well as, when combined with anti-PD-L1. Survival data from this preclinical work are expected this summer. Results from the preclinical models discussed above will be utilized to help finalize the design of a Phase 2 clinical trial in humans in advanced pancreatic cancer using checkpoint blockade plus Ampligen at the University of Nebraska Medical Center with Dr. Kelsey Klute as the principal investigator.

Hemispherx is studying the use of Ampligen as a combinational therapy for the treatment of multiple cancer types at major cancer centers throughout the United States. In fact, as recently as last month the company announced IRB approval of a clinical study in metastatic triple negative breast cancer in collaboration with the Roswell Park Comprehensive Cancer Center (RPCCC). This study is now open for recruitment of patients. Also, a study of colorectal cancer metastatic to the liver being conducted at RPCCC has enrolled six of the planned 12 patients. At the University of Pittsburgh enrollment has commenced in a 45 subject ovarian cancer study combining Ampligen with anti-PD-1 therapy.

About Hemispherx Biopharma
Hemispherx Biopharma, Inc. is an immuno-pharma R&D and emerging commercial growth company focused on unmet medical needs in immunology. 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. 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. Among other things, no assurance can be given as to whether Ampligen will prove an effective treatment for pancreatic cancer or any other cancer, significant further trials are necessary and no assurance can be given that ongoing or planned trials will be successful or yield favorable data and the trials are subject to many factors including lack of regulatory approval(s), lack of study drug, or a change in priorities at the sponsoring Universities or Cancer Centers. 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.
Phone: 800-778-4042
Email: IR@hemispherx.net


LHA Investor Relations
Miriam Weber Miller
Senior Vice President
Phone: +1-212-838-3777
Email: mmiller@lhai.com

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