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Ampligen Owner Completes Stock Offering, Faces Court Trials

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By By: Katie Ferren • www.ProHealth.com • March 1, 1996


The company which recently developed Ampligen has changed names and has put forth an initial public offering of common stocks and warrants.

Public shares were originally sold six months ago in November for Hemispherx BioPharma, Inc. (formerly HEM Pharmaceuticals Corp.). The initial public offering raised around $16 million, which will be used primarily to complete previous research, as well as develop some new trials. The company is currently traded on the NASDAQ exchange under the symbol HEMXU. The offering price was S3.50 and the units have since traded from $3.00 to above $8.00.

Hemispherx BioPharma hopes to win approval to use Ampligen for use against HIV, chronic hepatitis B virus, and CFIDS (Chronic Fatigue Syndrome). Currently, the company is conducting trials regarding its effectiveness on several diseases.

For example, the company received approval from the Canadian HPB (Health Protection Board) to conduct an open- label clinical trial in Canada of ampligen group to 200 patients suffering from CFIDS.

Another trial is currently underway in Belgium, authorized by the Belgian Minister of Health.

In addition, Hemispherx BioPharma has licensed SAB-Bioclones of South Africa to be the exclusive manufacturer of Ampligen for Africa. They will be specifically researching the use of Ampligen as a possible treatment for Hepatitis C.

Finally, the company is evaluating the results of the second phase of a clinical trial for HIV patients, and a Phase 1111 trial for _HBC patients. It appears the company may wish to gain regulatory approval for HIV first, then pursue approval for HBC and CFIDS in the future.

Unfortunately, the company has been involved in several lawsuits recently, and it is possible that public offering funds will only keep the company funded for the next two years. Further financing may be needed once the company reaches the stage of approval as well as commercialization of Ampligen.

Temple University is seeking to terminate a license agreement related to the development of Oragen compounds (Oragen the second generation of Ampligen, administered orally instead of intravenously).

Vanderbilt University is also contesting one of the company's patents for the use of Ampligen with HIV For now, the future of the company producing Ampligen is uncertain.



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