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Ampligen In Clinical Trial Treating HIV Patients In Texas.


PHILADELPHIA--(HealthWire)--January 13, 1996--HEMISPHERx BIOPHARMA INC inc - /ink/ increment, i.e. increase by one. Especially used by assembly programmers, as many assembly languages have an "inc" mnemonic.

Antonym: dec.
. (NASDAQ NASDAQ
 in full National Association of Securities Dealers Automated Quotations

U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on
: HEMX, HEMXW) announced today that they had begun a new Phase II clinical trial Noun 1. phase II clinical trial - a clinical trial on more persons than in phase I; intended to evaluate the efficacy of a treatment for the condition it is intended to treat; possible side effects are monitored
phase II
 in Texas treating HIV HIV (Human Immunodeficiency Virus), either of two closely related retroviruses that invade T-helper lymphocytes and are responsible for AIDS. There are two types of HIV: HIV-1 and HIV-2. HIV-1 is responsible for the vast majority of AIDS in the United States.  infected patients with the Company's proprietary drug, Ampligen(R).

The trial, recently approved by the FDA FDA
abbr.
Food and Drug Administration


FDA,
n.pr See Food and Drug Administration.

FDA,
n.pr the abbreviation for the Food and Drug Administration.
, will study the effect of Ampligen on viral load, or burden, in HIV patients with CD4 levels over 400 cells/mm3 who are not being treated with any other HIV medications.

The principal investigator in the trial, Dr. Patricia Salvato, specializes in the treatment of individuals with HIV infection. Dr. Salvato is a Clinical Associate Professor at the University of Texas Health Science Center, and has participated in prior clinical trials of Ampligen for various chronic viral diseases including HIV and Chronic Fatigue Syndrome chronic fatigue syndrome (CFS), collection of persistent, debilitating symptoms, the most notable of which is severe, lasting fatigue. In other countries it is known variously as myalgic encephalomyelitis, chronic fatigue and immune dysfunction syndrome, and  (CFS).

Recent clinical results from a previous multicenter, placebo-controlled study of Ampligen in HIV disease were published in the July, 1996 issue of the European Journal of Microbiology and Infectious Diseases. This study showed that subjects with baseline CD4 levels over 300 cells/mm3 were less likely to develop AIDS when treated with Ampligen, than were similarly treated placebo receiving subjects. The drug was also well tolerated in this study.

Ampligen is also currently undergoing Phase II clinical trials in Belgium for the treatment of CFS. It has also been found to be active in treating Hepatitis B and renal cell cancer.

HEMISPHERx is a biopharmaceutical company engaged in the manufacture and global clinical development of new drug entities in the nucleic acid (NA) class for chronic viral diseases and disorders of the immune system. To date, HEMISPHERx and its subsidiaries have received over 200 patents internationally to protect its proprietary position in NA and related drug technologies. Pharmacia/Upjohn and South African Breweries/Bioclones are the strategic partners who cooperate with HEMISPHERx in the overall drug manufacturing process.

CONTACT: HEMISPHERx BIOPHARMA, INC.

Dr. William A. Carter, (215) 988-0080

or

VMW VMW Virtual Medical Worlds
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, Inc., New York

Vicki Miles Weiner, (212) 605-3140,

VMWeiner@aol.com
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Publication:Business Wire
Date:Jan 13, 1997
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