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CST: 24/05/2019 19:49:44   

Hemispherx Announces the First Participant Received Initial Dosing in Breast Cancer Clinical Trial Using Hemispherx’ Ampligen and Pembrolizumab

52 Days ago

OCALA, Fla., April 02, 2019 (GLOBE NEWSWIRE) -- (NYSE American: HEB) — Hemispherx today announced active initiation of a clinical trial sponsored by Roswell Park Comprehensive Cancer Center (Roswell Park) in Buffalo, N.Y. evaluating Hemispherx’ experimental drug Ampligen® (rintatolimod), a dsRNA TLR3 agonist, in combination with Merck’s Keytruda® (pembrolizumab), an anti-PD-1 check-point blockade therapy, in the treatment of metastatic triple-negative breast cancer. The study’s first participant received initial dosing this week. The phase I trial seeks to enroll at least six patients.  (https://clinicaltrials.gov/ct2/show/NCT03599453?term=ampligen&cond=Triple+Negative+Breast+Cancer&cntry=US&state=US%3ANY&rank=1).

Lead investigators Drs. Mateusz Opyrchal and Pawel Kalinski of Roswell Park will evaluate the impact of Ampligen-based chemokine modulation therapy when given prior to pembrolizumab in the treatment of patients with metastatic triple-negative breast cancer. Drugs used in this chemokine modulation therapy — celecoxib, recombinant interferon alfa-2b, and Ampligen — potentially work by unleashing or enhancing the cancer immune responses that already exist by either blocking inhibitory molecules or by activating stimulatory molecules. Based on past experimental and clinical data, the research team is undertaking the study to determine whether this approach can positively modify the tumor microenvironment to convert previously ‘cold’ tumors not susceptible to checkpoint blockade therapy into ‘hot’ tumors which are optimally primed for checkpoint-blockade therapies.

"We are very excited to see the first patient treated as part of this important clinical trial evaluating Ampligen in combination with pembrolizumab in patients with metastatic triple-negative breast cancer. We could not ask for better partners than the world-class team at Roswell Park Comprehensive Cancer Center, as we seek to evaluate the impact of the combined therapy on this high risk and very sick patient population,” said Hemispherx CEO Thomas K. Equels. "Our extensive work with Ampligen has led many top oncologists to conclude, including in peer reviewed medical journal articles, that Ampligen has the potential to change the tumor microenvironment. Making tumors easier targets for checkpoint blockade therapies creates an exciting new approach with the potential to significantly improve clinical outcomes for patients in multiple solid tumor cancer types."

Learn more about the Roswell Park clinical study: https://www.roswellpark.org/clinical-trials/list/3812

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 the trial at Roswell Park or other 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 Roswell Park or the Universities or Cancer Centers sponsoring other 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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