Gay Men's Health Crisis: Treatment Issues, Volume 7 no. 7 July/August, 1993
David Gold

SmithKline Beecham, a Philadelphia-based drug company, plans to file a New Drug Application (NDA) for famciclovir, a new broad spectrum anti-herpes drug similar to acyclovir, by the end of the year. The NDA will probably be for herpes zoster ("shingles") with additional indications, including herpes simplex, and European filings to follow in 1994. SmithKline claims famciclovir is more bioavailable than acyclovir and has a greater intracellular half-life. SmithKline expects that famciclovir will require less frequent dosing than acyclovir.

Dan Hoth Quits NIAID For Biotech Industry

Dan Hoth, M.D., Director of the Division of AIDS (DAIDS) of the National Institute of Allergy and Infectious Disease, left his government position to become a Senior Vice President and Chief Medical Officer of Cell Genesys, a California biotechnology firm. Cell Genesys is developing universal killer T cells which target HIV antigens. Universal killer T cells are modified to function in all individuals. Currently, transplanted immune cells must be genetically matched between donor and recipient. Clinical trials are expected to begin by early 1994. Dr. Jack Killen has been appointed Acting Director of DAIDS until a replacement is found. The Director of DAIDS is a key figure in the government's AIDS research program; we will watch closely to see if Dr. Anthony Fauci, the Director of NIAID, appoints a well-respected, high quality scientist to the position.

The Return of Thalidomide

Celgene, a biotech company, filed a series of broad patents covering AIDS-related uses of thalidomide and its analogs. Celgene's patents are based largely on the work of Dr. Gilla Kaplan of Rockefeller University. Kaplan reported in The Proceedings of the National Academy of Science (July 1) that thalidomide can reduce tumor necrosis factor (TNF) production without affecting synthesis of other proteins. TNF is a protein produced by immune cells in response to infection and cancer. Elevated TNF levels have been connected to several disease processes, including increased HIV replication. Presently, thalidomide is used to treat an immunological condition which occurs in people with leprosy. Several small studies have suggested a role for thalidomide in the treatment of oral aphthous ulcers in people with AIDS. A 40-person study is underway at Rockefeller University to elucidate thalidomide's role in HIV treatment. Thalidomide is best remembered as the the drug first used as a treatment for morning sickness in pregnant women which caused severe birth defects in their offspring. The thalidomide controversy led to the drug's market withdrawal in the United States and Europe in the early 1960s and the creation of the present mandate of the Food and Drug Administration (FDA).

Triple TB Treatment NDA

Marion Merrel Dow, a Kansas City, Missouri-based drug company, filed a New Drug Application (NDA) for Rifater, a three-in-one combination of rifampin, isoniazid, and pyrazimamide, three widely- used tuberculosis treatments. The company already markets rifampin under the brand name Rifadin. The company hopes its three- in-one product will improve patient compliance by reducing the number of pills in a TB treatment regimen.

HIVIG for Vertical Transmission Studies

North American Biologics Supplies will provide HIVIG (HIV-specific immune globulins) to the National Heart, Lung and Blood Institute of the NIH for a phase II clinical trial in HIV-positive pregnant women. The study will the test the ability of HIVIG to prevent HIV transmission from mother to fetus. Four hundred women are expected to enroll in the study, which will begin in September. The company hopes this study will provide convincing evidence of HIVIG's efficacy.

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