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Pharmaceutical Update

Pharmaceutical Update


' Dermik Laboratories, the U.S. dermatology arm of Aventis Pharmaceutical, has applied with the Food and Drug Administration for expedited premarket review of Sculptra, a lipoatrophy treatment already sold overseas as New-Fill. Sculptra, a synthetic poly-L-lactic acid, is injected under the skin to fill spaces left by loss of subdermal fat. ' The National Institutes of Health, the Centers for Disease Control and Prevention, and the Bill and Melinda Gates Foundation are funding three separate trials to determine if Viread is useful in preventing HIV infections. ' Chiron has announced it will start a two-year, 168-person test of its two-part HIV vaccine. The U.S. study will gauge the vaccine's safety and determine if it boosts the immune system's ability to recognize and fight the virus in the body. ' Researchers at Australian biotechnology company Virax have reported that data from a Phase I human trial of therapeutic HIV vaccine VIR201 show the vaccine is effective at reducing viral levels in HIV-positive people by boosting immune system responses to the virus. Study subjects who received VIR201 had viral levels six times lower than those given a placebo. No adverse side effects were reported. ' Gilead Sciences has announced it ended a licensing agreement with two U.S. universities to develop the antiretroviral amdoxivir. The company will instead focus on other anti-HIV medications in development. ' A study presented at the 11th Conference on Retroviruses and Opportunistic Infections has shown that adults coinfected with HIV and hepatitis C have a better chance of clearing HCV from their bodies through a new treatment combining Pegasys with the antiviral drug ribavirin. ' Pharmasset and Incyte have reported that preliminary results from a Phase II trial of experimental nucleoside reverse transcriptase inhibitor Reverset show that the once-daily medication reduced viral loads by 98% in study subjects taking the drug for 10 days. Earlier tests have shown Reverset to be effective in treating virus resistant to Retrovir and Epivir. ' GlaxoSmithKline has reported that a Phase I clinical trial of experimental HIV fusion inhibitor 873149 shows that the drug blocked the CCR5 receptors on the surface of CD4 cells by 95% to 100% regardless of the dosage used. The company is now enrolling patients for a Phase II trial. ' Bristol-Myers Squibb has reported data from a Phase II clinical trial of experimental fusion inhibitor BMS-488043 that show the drug lowered blood-based viral levels and led to CD4-cell increases in patients taking the medication twice daily for eight days.

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