Hemispherx Biopharma preps for NDA filing with addition of scientists, executives

By Lisa Kerner

Erie, Pa., April 25 - Hemispherx Biopharma, Inc. retained a team of scientists and executives with experience in immunology, pharmaceutical manufacturing and regulatory compliance in preparation for the company's filing of a New Drug Application for the experimental immunostimulant Ampligen, developed for the potential treatment of Chronic Fatigue Syndrome (CFS).

There is no approved therapy for CFS, which affects nearly 1 million Americans, according to a company news release.

Michael D. Young was named senior vice president. Founder of Michael D. Young Associates, he has more than 30 years of experience in the pharmaceutical industry, including clinical research as well as toxicology, drug metabolism and product formulation.

To assist in regulatory initiatives, Hemispherx retained Alastair George Ramsay as senior vice president. Ramsay, experienced in vaccine development, founded Albamed, a consulting company.

The company named Wayne R. Godfrey to the position of associate medical director to focus on preclinical and clinical studies for development of the immunostimulant Ampligen. A former professor, Godfrey was most recently director of cellular immunology at a biotechnology company.

Hemispherx is also partnering with two consulting firms. Octagon Research Solutions, specializing in electronic transformation of clinical research and development for NDAs, will streamline the regulatory filing process.

SM&A will improve the process of responding to various federal procurement opportunities for the experimental immunotherapeutic Ampligen and the approved natural interferon product, Alferon N.

Hemispherx, based in Philadelphia, manufactures and develops products for the treatment of viral and immune-based chronic disorders.

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