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CST: 22/09/2019 11:16:30   

Hemispherx Biopharma Announces First Patient Treated in Phase 2 Ovarian Cancer Clinical Trial Evaluating Ampligen in Combination with Pembrolizumab and Cisplatin

101 Days ago

OCALA, Fla., June 12, 2019 (GLOBE NEWSWIRE) -- (NYSE American: HEB) — Hemispherx Biopharma Inc. announced today that the first patient has been treated in the Phase 2 recurrent ovarian cancer program at the University of Pittsburgh Medical Center (UPMC) (See: https://clinicaltrials.gov/ct2/show/NCT03734692). On receipt of information from clinical sites, it is Hemispherx’ policy to provide periodic updates when a clinical study (1) is FDA authorized, (2) begins enrollment, (3) treats its first subject, (4) issues material interim reports and (5) releases final results. The company is pleased to announce this step in our clinical program, which constitutes steady progress toward Hemispherx’ clinical goals.

Under the leadership of principal investigator Robert Edwards, MD, this study is evaluating Hemispherx' experimental drug Ampligen in combination with pembrolizumab — an anti-PD-1 check-point blockade therapy — and cisplatin. This study is expected to treat 45 patients.

This is the second recurrent ovarian cancer clinical trial involving Ampligen at UPMC. A Phase 1 / 2 commenced approximately three years ago and is near completion of the Phase 1 portion (See: https://clinicaltrials.gov/ct2/show/NCT02432378). Dr. Edwards’ team has issued an interim report and is drafting a manuscript on the biological and clinical outcomes from the initial Phase 1 / 2 clinical trial in recurrent ovarian cancer.

"Our initial study indicates that Ampligen is generally well-tolerated via intraperitoneal administration, thus paving the way for this new Phase 2 study combining Ampligen and pembrolizumab. 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, and a world-class expert in ovarian cancer and a pioneer in Ampligen research.

"This year, world-wide, ovarian cancer is projected to kill 152,000 women. With this new large-scale study funded by an industry grant, Hemispherx and the team at Magee-Women's Hospital of the University of Pittsburgh School of Medicine are focused on developing a potentially life-saving therapy to meet this critical and unmet medical need," said Hemispherx CEO Thomas K. Equels.

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. Among other things, no assurance can be given as to whether the 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 of the Cancer Centers sponsoring these trials. 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.

Contacts:

Hemispherx Biopharma, Inc.
Phone: 800-778-4042
Email: IR@hemispherx.net

Or

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

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