Hemispherx secures US composition of matter patent covering Ampligen formulations

The patent claims a novel form of rugged dsRNA. Rugged dsRNA are nucleic acids with a unique composition and physical characteristic identified with high specificity of binding to Toll-Like Receptor 3 (TLR3), thereby conveying an important range of therapeutic opportunities.

The newly discovered form of dsRNA has increased bioactivity and binding affinity to the TLR 3 receptor because of its reduced tendency to form branched dsRNA, which can inhibit receptor binding. Pharmaceutical formulations containing the newly discovered nucleic acid as active ingredients, and methods of treatment with those formulations, are also described in the issued patent.

The original U.S. composition-of-matter patent on Ampligen was issued to Johns Hopkins University in the early 1970’s, published in the Journal of Molecular Biology, and thereafter licensed to Hemispherx Biopharma, Inc. exclusively.

Upon expiration of the original patent, Hemispherx relied on a continued research program and sizable portfolio of subsequently issued patents to maintain a degree of proprietary protection for novel compositions and treatment methods based on Ampligen technology.

The issuance of U.S. Patent 8,722,874 will help ensure that Hemispherx Biopharma retains patent protection for novel formulations of Ampligen products until at least 2029. The current Ampligen formulations, as a mixture of RNA of different sizes and variable binding affinities to cell receptors affords a unique array of potential disease fighting properties through antiviral and immunomodulatory mechanisms.

The newly issued patent discusses how dsRNAs acting thru TLR3 receptor activation are potent antiviral compounds and anticancer agents and through secondary immunomodulators that can enhance the bioactivity of vaccines and treat autoimmune diseases.

The recent Hemispherx effort was started by isolating and characterizing novel specific molecular species of dsRNA which convey remarkable bioactivity previously attributed to a broad class of molecules and mixtures thereof.

The Hemispherx inventors discovered, using highly sophisticated analytical methods, that a highly specific set of molecules discovered based on Ampligen technology is responsible for a disproportionately higher percentage of one or more aspects of Ampligen(R)’s desirable biological activity.

The significant extension of proprietary longevity via the new composition-of-matter patent may favorably affect patent longevity of Ampligen(R) in approximately 20-25 countries.