PHILADELPHIA, Aug. 14, 2017 (GLOBE NEWSWIRE) -- Hemispherx Biopharma (NYSE MKT:HEB) announced that it has commenced full data analysis of an intranasal human safety study of Ampligen® plus FluMist® known as AMP-600. The study was previously closed, but the initiation of full data analysis awaited the FDA’s evaluation of preliminary reports of blinded study findings. That evaluation was completed per formal notification from the FDA on August 9, 2017. Intranasal Ampligen was generally well-tolerated in the study.
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This study is the first to evaluate the human safety of nasally-administered Ampligen. Test subjects in other human studies of Ampligen, including the pancreatic cancer treatment program currently underway in The Netherlands, have been administered Ampligen intravenously (IV). All told, approximately 100,000 IV doses of Ampligen have been administered and found to be generally well-tolerated.
Hemispherx believes that the top line data from the intranasal safety study, coupled with extensive pre-clinical data, support further development of Ampligen as a broadly applicable highly selective Toll-like Receptor 3 (TLR-3) based new generation, immune enhancing adjuvant for intranasally-administered vaccines.
“We’re very encouraged by the outcome of this study, establishing a foundation for Ampligen as an intranasal adjuvant. This shows Ampligen’s potential to take us to the next step of developing Ampligen either as a strain-specific or more universal influenza intranasal vaccine immune enhancing adjuvant”, said Thomas Equels, Hemispherx’s Chief Executive Officer. “This safety study was the first milestone to our ultimate goal, which is to combine Ampligen with a non-live virus vaccine to produce stronger and broader coverage and to confer longer immunity than is possible with the vaccine alone. I firmly believe that Ampligen’s multi-faceted impact on the immune system redefines the term adjuvant.”
Ampligen is a highly selective TLR-3 agonist that induces the innate immune responses required for adaptive protective immunity. Monkeys immunized with H5N1 vaccine and Ampligen showed enhanced protection after being challenged with a homologous highly pathogenic H5N1 virus. Pre-clinical studies also showed cross-protection against H5N1 viruses using trivalent seasonal influenza vaccine in mouse models. In theory, Ampligen induced cross-protection may extend to any vaccine for viruses subject to a high mutation rate and genetic drift.
Ampligen is currently being developed as an immuno-oncology agent in solid cancer tumors and as a treatment in Chronic Fatigue Syndrome (CFS). Studies have shown that the two totally different indications both benefit from Ampligen’s foundational strength as an immuno-therapeutic. The company has completed a pivotal Phase 3 clinical trial in ME/CFS, where it is the only late-stage drug in the pipeline for this disease. The U.S. FDA has advised that potential approval for commercial sale in the U.S. for a ME/CFS indication will require the conduct and review of a follow up confirmatory clinical trial. Hemispherx is supplying the drug for use by pancreatic cancer patients in an Early Access Program sponsored by the Dutch government.
In AMP-600, Ampligen was nasally-administered as an adjuvant in conjunction with FluMist®, a seasonal live-virus flu vaccine, to healthy human volunteers at the University of Alabama at Birmingham under the auspices of Paul Goepfert, MD, Associate Professor of Medicine in the Division of Infectious Diseases and Director of the Alabama Vaccine Research Clinic. Twenty-five subjects were enrolled, twelve in Stage 1 and thirteen in Stage 2. The data from the AMP-600 safety study extends the pre-clinical results into humans. In the study, Ampligen was generally well-tolerated when administered intranasally with a live-virus influenza vaccine. Future studies with non-live virus vaccines will seek to replicate Ampligen’s efficacy as shown in the animal model results.
“Our next milestone for intranasal Ampligen is to collaborate with an established vaccine maker to administer Ampligen intranasally with a non-live virus vaccine,” said Equels, “this next milestone will allow us to determine Ampligen’s clinical efficacy as a viral vaccine adjuvant and to evaluate it as a mechanism for providing cross protection from virus mutations as well as other forms of the virus. We have every expectation of results similar to the prior animal studies.”
About Hemispherx Biopharma
Hemispherx Biopharma, Inc. is an advanced specialty pharmaceutical company engaged in the clinical development of new drug entities for treatment of seriously debilitating disorders. Hemispherx’s flagship products include Alferon N Injection® and the experimental therapeutics rintatolimod (tradenames Ampligen® or Rintamod®). Rintatolimod is an experimental RNA nucleic acid 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 potential treatment of various severely debilitating and life threatening diseases. Because rintatolimod is experimental in nature, it is not designated safe and effective by the FDA for general use and are legally available only through clinical trials. For more information about Hemispherx visit www.hemispherx.net.
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. In addition to the risk factors identified from time to time in our reports filed with the Securities and Exchange Commission, no assurance can be given that Hemispherx will be able to engage one or more partners to conduct studies to confirm that Ampligen® is effective as a universal viral vaccine adjuvant or its effectiveness when administered intranasally or that any future studies will confirm such effectiveness. Moreover, conducting such studies will require Hemispherx to obtain additional financing and no assurance can be given that such funding will be available. While we are planning possible cancer trials of Ampligen in the U.S., we will need significant additional funding to commence and conduct such studies. 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.