|May 08, 2003
|Hemispherx Biopharma: New NIH Sponsored Data on Ampligen presented with West Nile Virus
|Ampligen effective in reducing morbidity and mortality in two different animal studies New FDA Regulations may permit accelerated commercialization
Philadelphia, PA, Thursday, May 08, 2003: Hemispherx Biopharma, Inc. (AMEX: HEB) announced today that at the 16th International Conference on Antiviral Research, scientists of the Institute for Antiviral Research of Utah State University presented data, funded by the National Institutes of Health (NIH) and National Institutes of Allergy and Infectious Diseases (NIAID), which evaluated the Company’s experimental agent Ampligen® against West Nile Virus (WNV) in two animal models.
New FDA Regulations and Accelerated Approval based on Animal Studies
On May 31, 2002, FDA published a final regulation in the Federal Register to allow appropriate studies in animals to provide substantial evidence of effectiveness of new drug products when intended for use in reducing or preventing toxicity of chemical, biological, radiological, or nuclear substances (67 Fed. Reg. 37988). The scope of the regulation includes drugs intended to ameliorate or prevent serious or life-threatening conditions caused by exposure to lethal or permanently disabling toxic biological substances. The main criteria for accepting animal studies as the sole evidence of a drug’s efficacy is the evidence that the drug’s effect is demonstrated in more than one animal species expected to react with a response predictive for humans.
About West Nile Virus
The West Nile virus appears to be firmly established in the United States, and researchers expect its continued spread and entrenchment in wildlife and human populations. Since 1999, WNV has been detected in horses, birds, mosquitoes and humans in 44 States. As of 5 February 2003 the Centers for Disease Control and Prevention have verified 4008 human cases of West Nile virus for 2002-2003, resulting in 263 deaths.
WNV is spread by the bite of an infected mosquito and West Nile virus infection can result in severe and fatal illnesses.
About the Animal Models predictive of “Substantial Evidence of Efficacy”
The NIH sponsored testing consisted of two different animal studies, BALB/c mouse studies and Golden Hamster studies. These animal models closely resemble the West Nile Virus in humans as far as disease characteristics. The new data shows evidence that Ampligen®, a double stranded RNA experimental drug acting potentially as an immunomodulator and antiviral, is effective in reducing morbidity and mortality. The researchers reported that a single dose of Ampligen® (13 mg/kg), up to 1 day before challenge, administered intraperitoneally every other day prevents or reduces morbidity and mortality of WNV infections.
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 chronic disorders. Its flagship products include Alferon, Ampligen and Oragens. These novel proteins and nucleic acids are being developed for globally important chronic viral diseases and disorders of the immune system including HPV, HIV, CFS and Hepatitis. Its platform technology includes large and small agent components for potential treatment of various chronic viral infections. Hemispherx has approximately 400 patents comprising its core intellectual property estate, a fully commercialized product (Alferon N) and GMP certified manufacturing facilities for its novel pharma products. For more information please visit www.hemispherx.net
Hemispherx Biopharma, Inc.
Dianne Will, Investor Relations
(518) 398-6222, Fax: (518) 398-6223
HEB's Web Site: 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 AmpligenÒ and Oragensä) 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 AlferonÒ do not imply that the product will be specifically approved commercially for these other treatment indications.