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All Quiet on the Development Front

All Quiet on the Development Front


Treatment research reached a fever pitch in the final months of last year. The first oral entry inhibitor, Selzentry, was approved by the Food and Drug Administration, as was Isentress, the first drug to emerge in the new integrase inhibitor class. And just days into this year, Intelence, a second-generation nonnucleoside, received the FDA's nod. But in recent months news of advancements, like those milestones, has quieted, and a close look at the development pipeline shows that the immediate future is going to be uneventful indeed. Although there are 149 different compounds being studied, none will reach the market this year. In fact, while there are 27 experimental medications in clinical trials, none are in Phase III human trials'the final stage of research before FDA approval is sought'and only seven are in full Phase II efficacy studies. The upside is that, although there will be no new anti-HIV drugs approved in the foreseeable future, the medications that are the farthest along in development offer significant benefits over existing medications by attacking the virus in new ways, being more potent than similar drugs, producing fewer side effects, or being taken less frequently. The obvious downside is that most are still years away. DRUGS IN HUMAN STUDIESEntry Inhibitors: HGS004 (CCR5 blocker antibody), Phase I/II, Human Genome Sciences INCB9471 (CCR5 blocker), Phase II, Incyte PF232798 (CCR5 blocker), Phase I, Pfizer PRO140 (CCR5 blocker antibody), Phase I/II, Progenics Suc-HSA (gp120 blocker), Phase I, Sanquin TAK220 (CCR5 blocker), Phase I, Tobira (licensed from Takeda) TAK652 (CCR5 blocker), Phase I, Tobira (licensed from Takeda) TNX355 (CD4 blocker antibody), Phase II, Tanox and Biogen Vicriviroc (CCR5 blocker), Phase II, Schering-Plough Integrase Inhibitors: Elvitegravir (GS9137) , Phase II, Gilead Sciences GSK364735, Phase I, GlaxoSmithKline/Shionogi Nonnucleoside Reverse Transcriptase Inhibitors: 70h (GW678248), Phase I, GlaxoSmithKline BILR 355/r BS, Phase I/II, Boehringer Ingelheim Rilpivirine (TMC278), Phase II, Tibotec UK435061, Phase I/II, Pfizer Nucleoside Reverse Transcriptase Inhibitors: Amdoxovir, Phase II, RFS Pharma Apricitabine (AVX754), Phase I/II, Avexa DOT (dioxolane thymidine), Phase I, University of Georgia Elvucitabine (ACH126), Phase I/II, Achillion Fosalvudine (alovudine prodrug), Phase I/II, Heidelberg Pharmaceuticals Racivir, Phase I/II, Pharmasset Protease Inhibitors: PPL100, Phase I, Merck SPI452, Phase I, Sequoia Pharmaceuticals Other Classes: Bevirimat (PA457) (maturation inhibitor), Phase II, Panacos BI201 (anti-tat antibody), Phase I, BioInvent KP1461 (viral decay accelerator), Phase I/II, Koronis PA1050040 (gag processing inhibitor), Phase 1, Panacos

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