• Cobalis Corp., of Irvine, Calif., reported inconclusive results from preliminary top-line results from two Phase III trials for PreHistin in patients with moderate to moderately severe seasonal allergic rhinitis, commonly known as hay fever. The trials showed very low symptom levels in both placebo and PreHistin-treated patient groups, leaving no room to demonstrate a meaningful drug effect. In the randomized, six-week, placebo-controlled trials involving a total of 1,551 subjects, PreHistin did not achieve statistically significant differences from placebo in the primary measure of efficacy, the reduction in total nasal symptom score. However, the TNSS data for placebo-treated patients was far lower than would be expected for the moderate to moderately severe patient population called for in the protocol.

• Tibotec Pharmaceuticals Ltd., of Cork, Ireland, said results from a Phase III head-to-head study showed that a greater percent (77 percent) of treatment-experienced HIV-1 infected adults taking Prezista (darunavir)/ritonavir, with an optimized background regimen (OBR) of antiretroviral agents, reached a viral load of less than 400 copies/mL at week 48, compared to 68 percent of patients taking the widely prescribed medication lopinavir/ritonavir, with OBR, in a per-protocol analysis. In addition, significantly more patients receiving darunavir/ritonavir reached an undetectable viral load (<50 copies/mL) compared to patients taking lopinavir/ritonavir (71 percent vs. 60 percent). The company also reported that its investigational non-nucleoside reverse transcriptase inhibitor TMC125 demonstrated significant efficacy in patients with NNRTI resistance, according to the 24-week primary endpoint analysis from two ongoing, Phase III studies. The studies, known as DUET-1 and DUET-2, examined the use of TMC125 in treatment-experienced HIV-1 patients with documented resistance to NNRTIs. TMC125 is the first NNRTI to show significant efficacy in patients with NNRTI resistance. Data on both studies were published in the July 7, 2007 issue of The Lancet and will be presented at the 4th International AIDS Society Conference on HIV Pathogenesis, Treatment and Prevention July 25 in Sydney, Australia.