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Tobira's Next-Generation Once-Daily CCR5 Receptor Antagonist Demonstrates Efficacy, Safety and Tolerability in Treatment-Experienced Patients With HIV
Date:2/17/2010

SAN FRANCISCO, Feb. 17 /PRNewswire/ -- The first-ever-reported Phase II data for TBR-652, which is being developed by Tobira Therapeutics for the treatment of HIV infection, demonstrate that the CCR5 receptor antagonist provides potent antiviral activity and is generally safe and well-tolerated in its proof of concept trial. The data were released here today in an oral presentation at the 17th Conference on Retroviruses and Opportunistic Infections (CROI).

In a Phase IIa trial involving 54 treatment-experienced HIV infected patients, a 10-day course of once-daily, TBR-652 monotherapy produced a median nadir decline from baseline in HIV viral load of up to 1.8 log10 copies/mL. There were no serious adverse events, deaths or study drug-related discontinuations in the study.  Dose dependent changes in MCP-1 concentrations were also observed, demonstrating TBR-652's dual CCR5/CCR2 mechanism of action and potential anti-inflammatory benefits.  

"These data demonstrate that TBR-652 offers potent viral suppression and excellent safety and tolerability in this short-term study," observed Calvin J. Cohen, M.D., M.Sc., of the Community Research Initiative of New England. "This compound provides the potential for once-daily dosing, without the need for a pharmacologic boosting agent, an important benefit for simplified dosing and ease of administration in early stage disease."

Dr. Cohen presented data from Study 652-2-201, a double-blind, placebo-controlled, dose-escalation trial in which patients were randomized four-to-one to receive doses of TBR-652 of 25mg, 50mg, 75mg, 100mg, 150mg and placebo.  

All patients were HIV treatment-experienced, though none had previously been treated with a CCR5 antagonist. Most adverse events in the study were mild in severity (Grade 1). There were no clin
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SOURCE Tobira Therapeutics, Inc.
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