PHILADELPHIA, Jan. 9, 2008 (PRIME NEWSWIRE) -- Hemispherx Biopharma, Inc. (AMEX:HEB) announced today that it has formally submitted to the United States Food & Drug Administration ("FDA") detailed responses to all of the 14 questions posed by the FDA concerning the Company's New Drug Application ("NDA") for Ampligen(r), an experimental therapeutic, to treat Chronic Fatigue Syndrome ("CFS"). Hemispherx received the questions from the FDA on December 5, 2007, at which point the application was deemed by the FDA as "not sufficiently complete" to permit substantive review under 21 CFR 314.101(R). Consequently, the FDA's consideration of the NDA was postponed, pending receipt of the Company's answers to the questions.
The FDA questions spanned a range of clinical and preclinical topics. With the exception of a topical product for skin cancer, no TLR type compounds have yet received full regulatory clearance. TLR is an acronym for pharma compounds which signal broad "host defense" responses against various pathogens and disease conditions. Poly I: poly C12U (Ampligen(r)), an experimental therapeutic, is the first in this class of RNA (nucleic acid) molecules now seeking commercialization.
A recent independent study enumerated three primary causes of early death in CFS populations at large (without administration of Ampligen(r)) that may be attributable to the disease: 1) cardiovascular events, 2) suicide and 3) untreatable life-threatening malignancies/tumors. In response to the FDA's questions, as well as within the body of its NDA, Hemispherx addresses how Ampligen(r), an experimental therapeutic, may address these and other high risk aspects of CFS.
Only regulatory agencies can determine whether any experimental therapeutic, including Poly I: Poly C12U (Ampligen(r)) is "safe and effective." At this time, Ampligen(r), an experimental therapeutic, is only available in specific clinical trial settings conducted under specific governmental authorizations. It has not been determined to be "safe and effective" by any governmental body. Ampligen(r) represents an entirely new class of RNA-based drug therapies. The Company's prompt response to the questions posed by the FDA was made possible by the broad-based team of clinical and scientific experts assembled during 2007, with experience in successful global development of NDAs for new molecular entities ("NMEs"), such as Ampligen(r).
About Hemispherx Biopharma
Hemispherx Biopharma, Inc. is a biopharmaceutical company engaged in the manufacture and clinical development of new drug entities for treatment of seriously debilitating disorders. Hemispherx's flagship products include Alferon N Injection(r) and the experimental therapeutics Ampligen(r), Alferon LDO and Oragens(r). Alferon N Injection(r) is approved for a category of STD infection, and Ampligen(r) and Oragens(r) represent a large portfolio of experimental RNA nucleic acids being developed for globally important viral diseases, severely debilitating disorders and biodefense applications. Hemispherx's platform technology includes large and small agent components for potential treatment of various severely debilitating and life threatening diseases. Hemispherx has in excess of 100 issued patents comprising its core intellectual property estate, a fully commercialized product (Alferon N Injection(r)) and a GMP certified manufacturing facility for its novel pharma products. The Company is actively engaged in further expansion of its intellectual property on a world wide basis to reflect the global distribution of the various disorders which its platform technology addresses. For more information please visit www.hemispherx.net.
Information contained in this news release other than historical information, should be considered forward-looking and is subject to various risk factors and uncertainties. For instance, the strategies and operations of Hemispherx involve risk of competition, changing market conditions, change in laws and regulations affecting these industries and numerous other factors discussed in this release and in the Company's filings with the Securities and Exchange Commission. Any specifically referenced investigational drugs and associated technologies of the Company (including Ampligen(r), Alferon LDO and Oragens) are experimental in nature and as such are not designated safe and effective by a regulatory authority for general use and are legally available only through clinical trials with the referenced disorders. The forward-looking statements represent the Company's judgment as of the date of this release. The Company disclaims, however, any intent or obligation to update these forward-looking statements. Clinical trials for other potential indications of the approved biologic Alferon N Injection(r) do not imply that the product will ever be specifically approved commercially for these other treatment indications.