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GSK and Vertex Pharmaceuticals Announce Presentation of Data Supporting Development of Investigational HIV Protease Inhibitor Brecanavir
GSK and Vertex Pharmaceuticals Announce Presentation of Data Supporting Development of Investigational HIV Protease Inhibitor Brecanavir.
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[{"type":"text","content":"\n\n\n\n\n -- Positive Data Presented at 45th Annual ICAAC --\n\nCAMBRIDGE, Mass., Dec. 16 /CNW/ -- GlaxoSmithKline (GSK)\nand Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) presented positive\nresults today from a study evaluating the safety, tolerability and antiviral\nactivity of the investigational HIV-1 protease inhibitor (PI), brecanavir\n(formerly known as GW640385 or VX-385)(1). These data were presented at the\n45th Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC)\nheld in Washington DC. Interim findings following 24 weeks of dosing\ndemonstrated potent antiviral activity for brecanavir in both PI-sensitive and\nPI-resistant HIV-infected adults.\n\"These results support the ongoing development program for brecanavir,\nwhich is anticipated to enter Phase III development in 2006,\" said Lynn Marks,\nMD, Senior Vice President of the Infectious Disease Medicines Development\nCentre at GSK. \"If approved, brecanavir may be useful in treating patients\ninfected with strains of HIV that have become resistant to multiple protease\ninhibitors, and its clinical advancement underscores GSK's commitment to\ndeveloping new anti-HIV drugs.\"\n\nClinical Data on Brecanavir\nBrecanavir is an HIV protease inhibitor in Phase IIb clinical development.\nBrecanavir has received fast track designation from the U.S. Food and Drug\nAdministration and is being developed by GSK as part of a collaboration with\nVertex Pharmaceuticals.\nData presented were from a planned, 24-week analysis of an open-label\nstudy (HPR10006) of 48 weeks' duration evaluating the safety, tolerability,\nantiviral activity and pharmacokinetics of ritonavir-boosted brecanavir.\nThirty-one HIV-1 infected adults received 300mg of brecanavir twice-daily\nboosted with 100mg of ritonavir in combination with two nucleoside reverse\ntranscriptase inhibitors based on patient medical history and viral genotype.\nOut of 31 patients, 81 percent had plasma HIV-1 RNA below the level of\ndetection of standard assays (\n","length":5345,"tagName":"div"}]