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Hemispherx Biopharma Expands Manufacturing Facility for Production of Ampligen(R)

Posted on: Thursday, 1 September 2005, 15:00 CDT

Hemispherx Biopharma, Inc. (AMEX: HEB) discloses by letter to stockholders that it has increased the capacity of its facility in New Brunswick, N.J. to manufacture its experimental drug, Ampligen(R), as well as advancements in the application of Alferon LDO for the potential treatment of Avian Flu. The letter, which is being submitted as an 8-K with the SEC, highlights several key developments currently underway.

Hemispherx is implementing a three-phase strategy in its manufacturing process of Ampligen(R). The first component in this process highlighted in the stockholder letter is the establishment of production of Ampligen's raw material polymer in the Company's wholly owned New Brunswick, N.J. manufacturing facility. The creation of the polymer production capability has been initiated and Hemispherx expects to begin equipment validation in the facility in late September.

The second strategic component involves the formation of a partnership with a qualified contract manufacturer for finished product. The company is currently in the process of selecting a qualified candidate from a pool of already-identified and-pre-qualified contenders.

The third component of the manufacturing strategy is the development of the team responsible for the production of Ampligen(R) in New Brunswick, N.J. For the past 14 years, Ampligen(R) has been successfully produced for clinical trials and used for an ongoing Treatment IND program. The original management team responsible for that manufacturing remains in tact and has been augmented by the experienced GMP manufacturing team that was acquired with the Alferon-N acquisition.

The developments of the Alferon Low Dose Oral (LDO) trials are also highlighted in the stockholder letter. Clinical trials in human volunteers are underway in Philadelphia and will also shortly commence at the Princess Margaret Hospital in Hong Kong. Accordingly, there are currently more than 300,000 doses of Alferon LDO being prepared for these clinical programs.

Pending the outcome of the ongoing clinical studies, and based on existing laboratory studies, Hemispherx expects the trials may demonstrate that Alferon LDO, given orally, can activate the relevant immune defense pathways in the human body. This development would potentially make Alferon LDO the first orally active interferon drug candidate and would open an invaluable opportunity for a wide range of potential new indications. One such potential indication is for treating Avian Flu. As widely covered in the media, Avian Flu is a devastating, contagious disease. Worldwide health officials are concerned that Avian Flu could mutate to a highly contagious form transferable to humans from animals. This scenario is considered by experts in the field to be highly probable. Should this mutation occur, it will be the genesis of the next global pandemic and would render vaccines presently under development ineffective. The threat of a highly lethal pandemic has caused governments around the world to search for a treatment that they could potentially stockpile.

Consideration of Hemispherx's Alferon and Ampligen(R) therapeutics by the U.S. Department of Defense, in coordination with its Bio-defense strategy, is featured in an upcoming article in the Journal of Allergy and Clinical Immunology (JACI) as stated below:

The Department of Defense strategy will be outlined in an upcoming article entitled "Innate Immunity for Biodefense: A Strategy Whose Time Has Come" accepted for publication in the Journal of Allergy and Clinical Immunology (JACI). This article states that "Ampligen(R) has already been tested against over 25 viruses and will be used in Advanced Biosystem's proposal for inhaled IFN in conjunction with Alferon.... No evidence of inflammatory reactions has been observed in either Ampligen(R) or Alferon. Administration of over 50,000 doses of Ampligen(R) has not resulted in a cell-mediated autoimmune response. Alferon should be superior to single recombinant IFN types with regards to binding to receptors that are structurally altered by genetic polymorphisms."

Hemispherx CEO, Dr. William A. Carter concluded the stockholder letter, "With the acceleration of our manufacturing strategy for Ampligen(R) and our advancements in the development of the Low Dose Oral Interferon program, we feel that the company is poised to make considerable progress toward bringing the Hemispherx products to commercial success."

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 chronic disorders. Hemispherx's flagship products include Alferon and the experimental immunotherapeutics/antivirals Ampligen(R) and Oragens(TM). Alferon is approved for a category of STD infection, and Ampligen(R) and Oragens(TM) represent experimental nucleic acids being developed for globally important chronic viral diseases and disorders of the immune system including HPV, HIV, CFS, Hepatitis and SARS. Hemispherx's platform technology includes large and small agent components for potential treatment of various chronic viral infections. Hemispherx has in excess of 140 patents comprising its core intellectual property estate, a fully commercialized product (Alferon N) and GMP certified manufacturing facilities for its novel pharma product. 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) and Oragens(TM)) 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) do not imply that the product will ever be specifically approved commercially for these other treatment indications.

Source: Business Wire

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