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Hemispherx Biopharma Wins AMEX Compliance Approval, Looks Ahead to Promising Pharmaceutical Line-Up

Posted on: Thursday, 27 July 2006, 12:01 CDT

Hemispherx Biopharma, Inc. (AMEX: HEB) today announced that it has resolved its outstanding regulatory issues with the American Stock Exchange (AMEX). In a letter dated July 5, 2006, Hemispherx Biopharma, a biopharmaceutical company engaged in the manufacture and clinical development of new drug entities for the treatment of viral and immune-based disorders, was informed that after duly filing Form 10-K with the Securities and Exchange Commission for the year ended December 31, 2005 and the Form 10Q for the quarter ended March 31, 2006, it is now in full compliance. The company had missed the deadline for filing Form 10-K for the fiscal year ended December 31, 2005, violating AMEX guidelines.

"We are glad to put this regulatory issue behind us," said Dr. William A. Carter, Chairman and CEO of Hemispherx Biopharma. "Overall, this is an exciting time for our company."

Just last month at the First International Conference on Avian Influenza in Humans at the Pasteur Institute, Hemispherx announced that there's new evidence Alferon LDO (Low Dose Oral), a new experimental delivery form of the anti-viral with prior regulatory approval for a category of sexually transmitted diseases, shows significant potential in resisting the spread of avian flu by stimulating genes that induce the production of natural immune compounds that are key building blocks in the body's defense system. And the most recent issue of Science News, with a cover story on Chronic Fatigue Syndrome, highlights Ampligen(R), the Company's experimental therapeutic, as the only drug potentially nearing the market for the disease.

Parallel human volunteer studies in Asia with Alferon LDO now suggest its potential to treat the "cytokine storm" which various experts feel may account for the remarkably high death rate (85%) in children infected with the avian H5N1 influenza strain.

Alferon N Injection(R), Alferon LDO(R) and Ampligen(R) are at the heart of Hemispherx Biopharma's intellectual property portfolio of more than 100 patents and its globally conducted clinical testing programs.

Alferon N Injection(R) is the company's FDA approved treatment for human papilloma viruses (HPV), one of the most widespread sexually transmitted diseases in the United States. It's the first and only natural human alfa interferon product made available to physicians in the United States.

Alferon LDO is derived from Alferon N(R) and features a new experimental oral delivery method that would make mass distribution achievable and efficient.

Ampligen(R) is an experimental therapeutic. Hemispherx Biopharma recently completed a Phase III study of Ampligen(R) and is readying an FDA New Drug Approval application for the treatment of Chronic Fatigue Syndrome (CFS) a severely debilitating chronic flu-like illness. Recent studies with Ampligen(R) have also highlighted the drug's potential as an antiviral against avian influenza and as a novel immunostimulant that, when co-administered with vaccines, greatly increases their ability to sustain efficacy across mutating strains in various animal experimental models.

About Hemispherx Biopharma

Hemispherx Biopharma, based in Philadelphia, is a biopharmaceutical company engaged in the manufacture and clinical development of new drug entities for treatment of viral and immune-based disorders. Hemispherx Biopharma's flagship products include Alferon(R) and the experimental immunotherapeutics/antivirals Ampligen(R) and Oragens(TM). Alferon(R) is approved for a category of STD infection, and Ampligen(R) and Oragens(TM) represent experimental nucleic acids being developed for globally important viral diseases and disorders of the immune system. Hemispherx's platform technology includes large and small agent components for potential treatment of various viral infections. Hemispherx has in excess of 100 patents comprising its core intellectual property estate, a fully commercialized product (Alferon(R) N) and GMP certified manufacturing facilities for its novel pharma products within the United States. 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(R) 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(R) or the experimental therapeutic Ampligen(R) do not imply that the product will ever be specifically approved commercially for these other treatment indications.

Source: Business Wire

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