NNRTI

Ardea Biosciences' Lead NNRTI for HIV, RDEA806, to Enter Phase 2a Proof-of- Concept Clinical Trial

CARLSBAD, Calif., Dec. 31 /PRNewswire-FirstCall/ -- Ardea Biosciences, Inc. (Nasdaq: RDEA ) today announced that the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom has authorized a Phase 2a clinical trial evaluating RDEA806, a novel non-nucleoside reverse tra...

96-Week Safety and Efficacy Findings Presented for INTELENCE(TM) (etravirine) As Part of HIV Combination Therapy

...ant option for treatment-experienced patients with nnrti and PI resistance," said DUET clinical investigato...ion (FDA) in January 2008, INTELENCE was the first nnrti to be introduced in nearly ten years. Since then, ...ion (FDA) in January 2008, INTELENCE was the first nnrti to be introduced in nearly ten years. Since then, ...

GlaxoSmithKline and Pfizer Announce Innovative Agreement to Create a New World-Leading, Specialist HIV Company

...vir NRTI UK-453061 nnrti II Epivir/3TC NRTI GSK 2248761 nnrti II ...539 PK enhancer I Rescriptor nnrti (US only) GSK706769 CCR5 antagonist I ...

PREZISTA(R) Now Available for Pediatric Patients Six Years of Age and Older as part of HIV Combination Therapy

... median baseline CD4+ cell count was 330 cells/mm3 (range: 6 to 1505 cells/mm3). Most pediatric subjects (79 percent) had previous use of at least one nnrti and 96 percent of pediatric subjects had previously used at least one protease inhibitor PI. Pediatric subjects who were at risk of discontinuing...

Tibotec Submits Application to U.S. Food and Drug Administration Seeking Traditional Approval for INTELENCE(TM) (etravirine)

...pe 1 (HIV-1) infection in antiretroviral treatment-experienced adult patients, who have evidence of viral replication and HIV-1 strains resistant to a nnrti and other antiretroviral (ARV) agents. This indication is based on Week 24 analyses from two randomized, double-blind, placebo-controlled trials ...

Ardea Biosciences Reports Progress of Clinical Development Programs; Provides 2008 Outlook; Announces 2007 Financial Results and Provides 2008 Financial Guidance

...okinetic study and has been selected as a development candidate. In addition to the foregoing clinical programs, we are developing a second generation nnrti for HIV, as well as other drug candidates in earlier stages of preclinical development and discovery. Statements contained in this press release reg...

AAHIVM Encouraged by TMC125 Approval

...rienced adult patients with NNRTI-resistant virus. nnrti drug resistance occurs when HIV develops mutations that partially or completely stop the nnrti from binding to the reverse transcriptase enzyme, ...ncreasing concern over the cross-resistance of the nnrti class. A patient resistant to one NNRTI is general...

Tibotec Pharmaceuticals a Respectful Partner to HIV Community in Pricing of Novel New HIV NNRTI, INTELENCE

...E is an important new HIV medication that, for the first time, re-opens the nnrti class to patients with NNRTI-resistant virus," stated Donna Christian-Chist...major relief for me to have a new option as my present regimen combining an nnrti and a protease inhibitor which is both toxic and weakening. I think this is...

HIV drug resistance risk in mothers reduced by combination of common drugs

...o see if there was a difference in the presence of nnrti resistance mutations six weeks after giving birth....ven the tenofovir and emtricitabine dose developed nnrti resistance, compared to 25 percent among those who...fects. Although these additional drugs did prevent nnrti resistance, their use did not lead to substantial ...

FDA Accepts New Drug Application for Priority Review of Investigational HIV Treatment TMC125

...g the application, will be January 18, 2008. The NDA for TMC125, the first nnrti to show antiviral activity in patients with documented nnrti resistance, is based on the 24-week efficacy and safety results of two ongo...

NNRTI in Medical Technology

Idenix Pharmaceuticals and GlaxoSmithKline Sign Worldwide License Agreement for IDX899, a Novel NNRTI for the Treatment of HIV

CAMBRIDGE, Mass. and LONDON, Feb. 6 /PRNewswire-FirstCall/ -- Idenix Pharmaceuticals, Inc. (Nasdaq: IDIX ) and GlaxoSmithKline (GSK) today announced the execution of a license agreement granting GSK exclusive worldwide rights to IDX899. IDX899 is a novel non-nucleoside reverse transcriptase inh...

Ardea Biosciences, Inc. Presents Results of Phase 1 Studies of RDEA806, a Novel NNRTI for HIV, at 47th ICAAC

- RDEA806 safe and well tolerated in single-dose and multiple-dose studies up to 14 days - No evidence of CNS disturbances, rash or elevations in lipids, side effects observed with other NNRTIs - Pharmacokinetics support further investigation with ...

TMC125 Showed Significant Virologic Response at Week 24 in Treatment-Experienced HIV Patients With NNRTI Resistance in Phase 3 Trials

Data Published in The Lancet on TMC125, an Investigational NNRTI from Tibotec YARDLEY, Pa., July 05, 2007 /PRNewswire/ -- Data from two ongoing Phase 3 studies (DUET-1 and DUET-2) showed significantly more HIV-1 adult patients with documented non-nucleoside reverse transcriptase inhibitor (NNRTI) ...

Ardea Biosciences Presents Preclinical Anti-Inflammatory Data on its Lead MEK Inhibitor, RDEA119, at the ACG 2008 Annual Meeting

...e inhibitor (NNRTI), which has successfully completed a Phase 2a study for the treatment of patients with HIV. We have evaluated our second-generation nnrti for the treatment of HIV, RDEA427, in a human micro-dose pharmacokinetic study and have selected it for clinical development. RDEA594, our lead produc...

Ardea Biosciences to Present Data on Lead MEK Inhibitor, RDEA119, at American College of Gastroenterology Annual Scientific Meeting

...e inhibitor (NNRTI), which has successfully completed a Phase 2a study for the treatment of patients with HIV. We have evaluated our second-generation nnrti for the treatment of HIV, RDEA427, in a human micro-dose pharmacokinetic study and have selected it for clinical development. RDEA594, our lead produc...

Ardea Biosciences Advances Lead Product Candidate for the Treatment of Gout, RDEA594, Into Phase 1 Clinical Trial

...t, exposure-dependent, decreases in serum uric acid of 35% to 50% observed during multiple dosing out to 14 days. About RDEA806 RDEA806 is a novel nnrti for the potential treatment of HIV infection. Based on preclinical and clinical studies to date, we believe that RDEA806 may have important competitiv...

Ardea Biosciences Reports Additional Positive Phase 2a Results for Lead HIV Candidate, RDEA806, Demonstrating Up to 1.9 Log Reduction in Plasma Viral Load with Once-Daily Dosing

...eoside reverse transcriptase inhibitor (NNRTI), which has completed a Phase 2a study for the treatment of HIV. We have evaluated our second-generation nnrti for the treatment of HIV, RDEA427, in a human micro-dose pharmacokinetic study and have selected it as a development candidate. RDEA594, our lead deve...

Ardea Announces Progress with HIV Non-Nucleoside Reverse Transcriptase Inhibitor Program

... These results are in contrast to the fetal malformations reported in other nnrti animal reproductive toxicity studies. Exploratory human testing (Phase 0)... 2a study for the treatment of HIV. We have evaluated our second-generation nnrti for the treatment of HIV, RDEA427, in a human micro-dose pharmacokinetic st...

Ardea Biosciences Presents Preclinical Data on RDEA119 Demonstrating Favorable Anti-Inflammatory Profile for Potential Use in Ulcerative Colitis

...non-nucleoside reverse transcriptase inhibitor (NNRTI), which is in a Phase 2a study for the treatment of HIV. We have evaluated our second-generation nnrti for the treatment of HIV, RDEA427, in a human micro-dose pharmacokinetic study and have selected it as a development candidate. RDEA594, our lead deve...

Ardea Biosciences Identifies Lead Development Candidate for Gout, RDEA594

...non-nucleoside reverse transcriptase inhibitor (NNRTI), which is in a Phase 2a study for the treatment of HIV. We have evaluated our second-generation nnrti for the treatment of HIV, RDEA427, in a human micro-dose pharmacokinetic study and have selected it as a development candidate. RDEA594, our lead deve...

NNRTI in Biological News

Resistant HIV quickly hides in infants' cells

... especially in light of the high rates of antiretroviral drug resistance occurring in infants in low-income countries who received a single dose of an nnrti for prevention of mother-to-child transmission, and for whom treatment options are few." In an accompanying editorial, Paul A. Krogstad, MD, of t...

Viral 'fitness' explains different resistance patterns to aids drugs

...a single mutation is required to create high-level nnrti resistance and these mutations have little impact ... of drug. Overall, study findings showed that nnrti resistance was found less often than PI resistance...rd combination therapy usually includes either one nnrti or protease inhibitor (non-boosted or boosted with...

NNRTI in Biological Technology

Idenix Pharmaceuticals Reports First Quarter Financial Results

...urities totaled $64.5 million. Business Highlights In the first quarter of 2009, the company announced that it had licensed its nnrti program for the treatment of HIV/AIDS, including IDX899, to GlaxoSmithKline (GSK) and received a $34 million payment, $17 million of which was a cash ...

Idenix Pharmaceuticals Reports Fourth Quarter and Year End Financial Results

...or (NNRTI) for the treatment of human immunodeficiency virus (HIV) in September 2008. In February 2009, the company announced that it had licensed its nnrti program, including IDX899, to GlaxoSmithKline (GSK) and, subject to closing conditions, will receive a $34 million payment, $17 million of which will ...

Ardea Biosciences to Present at the UBS Global Life Sciences Conference and the Third Annual JMP Securities Healthcare Focus Conference

...e inhibitor (NNRTI), which has successfully completed a Phase 2a study for the treatment of patients with HIV. We have evaluated our second-generation nnrti for the treatment of HIV, RDEA427, in a human micro-dose pharmacokinetic study and have selected it for clinical development. RDEA594, our lead produc...

Ardea Biosciences to Present Data on Gout and Inflammation Programs at the 2008 ACR/ARHP Annual Scientific Meeting

...e inhibitor (NNRTI), which has successfully completed a Phase 2a study for the treatment of patients with HIV. We have evaluated our second-generation nnrti for the treatment of HIV, RDEA427, in a human micro-dose pharmacokinetic study and have selected it for clinical development. RDEA594, our lead produc...

Ardea Biosciences to Present Data on Lead MEK inhibitor, RDEA119, at EORTC-NCI-AACR Symposium

...e inhibitor (NNRTI), which has successfully completed a Phase 2a study for the treatment of patients with HIV. We have evaluated our second-generation nnrti for the treatment of HIV, RDEA427, in a human micro-dose pharmacokinetic study and have selected it for clinical development. RDEA594, our lead produc...

Craig Johnson Joins Ardea Biosciences' Board of Directors

...non-nucleoside reverse transcriptase inhibitor (NNRTI), which is in a Phase 2a study for the treatment of HIV. We have evaluated our second-generation nnrti for the treatment of HIV, RDEA427, in a human micro-dose pharmacokinetic study and have selected it as a development candidate. RDEA594, our lead deve...

Ardea Biosciences Presents Inflammation Program Data for Arthritis and Gout at 2008 Annual European Congress of Rheumatology

...non-nucleoside reverse transcriptase inhibitor (NNRTI), which is in a Phase 2a study for the treatment of HIV. We have evaluated our second-generation nnrti for the treatment of HIV, RDEA427, in a human micro-dose pharmacokinetic study and have selected it as a development candidate. RDEA594, our lead deve...

Ardea Presents Preclinical Data on Novel Next Generation Non-Nucleoside Reverse Transcriptase Inhibitors Demonstrating Potent Anti-HIV Activity Against Resistant Viruses

... -- Lead nnrti RDEA806 to begin Phase 2b trial in the second quar...ttp://www.ardeabio.com ) under the title, "A Novel nnrti Class with Potent Anti-HIV Activity against NNRTI-...seases. Ardea also is developing a next-generation nnrti for HIV and a next-generation MEK inhibitor for bo...

Ardea to Present Data on HIV Non-Nucleoside Reverse Transcriptase Inhibitor and Two MEK Inhibitors at Upcoming Medical Conferences

...e: Monday, April 14, 2008 at 4:00 p.m. Eastern Time Title: A Novel nnrti Class with Potent Anti-HIV Activity against NNRTI-Resistant Virus...n to the foregoing clinical programs, we are developing a second generation nnrti for HIV, as well as other drug candidates in earlier stages of preclinical ...

Ardea to Present at Cowen and Company's 28th Annual Health Care Conference

...e 1 study in advanced cancer patients and is being investigated for the treatment of inflammatory diseases. Ardea also is developing a next-generation nnrti for HIV and a next-generation MEK inhibitor for both cancer and inflammatory diseases. Statements contained in this press release regarding matters ...