5th Conference on Retroviruses and Opportunistic Infections
February 1-5, 1998, Chicago



POTENT ANTIRETROVIRAL EFFICACY OF LOW-DOSE FTC: INITIAL RESULTS FROM A PHASE I / II CLINICAL TRIAL


February 1997


Media Contacts: Sarah Goodwin, 404/727-3366 - sgoodwi@emory.edu
Kathi Ovnic, 404/727-9371 - covnic@emory.edu
http://www.emory.edu/WHSC/





FTC, a new drug developed by scientists at Emory University for use against the AIDS virus and the Hepatitis B virus, has been shown to significantly reduce the viral load of HIV-1 in plasma at the first two dose levels in an ongoing Phase I / II trial in a small group of patients. FTC is an antiviral nucleoside analog in the same series as the drug 3TC. Preclinical results have shown that FTC's in vitro activity against HIV-1 is consistently greater than 3TC and that it possesses potent in vitro activity against hepatitis B (HBV).

In the Phase I / II trial FTC reduced the viral load of HIV-1 in plasma at the first dose level (25 mg twice a day) by an average of 96% over a 14-day period and at the second dose level (200 mg once a day) by an average of 99% over 14 days. The dose groups consisted of five HIV-infected volunteers each. The degree of viral suppression was very consistent among patients within each dose level, and the drug was very well tolerated. FTC was developed by Emory University researcher Dr. Dennis Liotta and Dr. Woo-Baeg Choi, in collaboration with Dr. Raymond Schinazi and licensed to Triangle Pharmaceuticals, based in Durham, N.C., in 1996. Franck Rousseau, Ph.D., Triangle's research director, will present results of the trial at the 5th Conference on Retroviruses and Opportunistic Infections in Chicago on February 5.

While FTC is not a cure for AIDS, it appears to shut down the virus's ability to reproduce itself and thus might postpone the progression of the disease. Nucleoside analogs target the reverse transcriptase enzyme inside the virus which is essential to HIV replication. FTC blocks viral replication without harming healthy cells.

NUCLEOSIDES WITH DUAL ANTI-HIV AND HBV ACTIVITY
Dr. Raymond Schinazi will present an abstract that outlines pre-clinical research with the nucleoside D-D4FC. In in vitro studies, D-D4FC demonstrated favorable virological and pharmacologic properties against HIV-1 and Hepatitis B virus (HBV). The molecule showed no in vitro toxicity and was not cross-resistant with AZT, DDC, DDI, D4T, 3TC FTC, L-D4FC, DXG, and various protease and non-nucleoside RT inhibitors.

Dr. Schinazi can be contacted at the Sheraton Hotel in Chicago next week during the conference. His telephone number here in Atlanta at the Veterans Affairs Medical Center is 404-728-7711.

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