• Achillion Pharmaceuticals Inc., of New Haven, Conn., announced positive safety and efficacy results from two ongoing Phase II clinical trials studying elvucitabine in HIV patients. Elvucitabine is an L-cytosine nucleoside analogue reverse transcriptase inhibitor. In the first trial, in the elvucitabine-treated group, 96 percent of patients reached undetectable viral load, defined as achieving fewer than 50 copies/ml after 24 weeks of therapy, compared to 94 percent in group getting 3TC (lamivudine). The second open-label extension phase of the second trial showed that eight of 14 patients who received elvucitabine, or 57 percent, achieved 0.5 log10 reduction or more in viral load, likely related to the fact that elvucitabine reaches steady-state levels in patients after approximately 21 days of treatment. Those data will be presented at a future scientific forum.

• Amgen Inc., of Thousand Oaks, Calif., and Wyeth Pharmaceuticals, of Collegeville, Pa., said findings from a retrospective analysis demonstrated that Enbrel reduced C-reactive protein (CRP), a marker of inflammation, in patients with moderate to severe plaque psoriasis following 12 weeks of treatment. Median reduction in CRP levels was 10 times greater in the Enbrel-treated group compared to the placebo group. Those results were to be presented at the American Academy of Dermatology Scientific Meeting in San Antonio, Texas. In other news, Amgen said positive data from two Phase III studies of Nplate (romiplostim) on increasing and sustaining platelet counts in both splenectomized (spleen removed) and nonsplenectomized patients with chronic immune thrombocytopenic purpura (ITP). The durable response rate was significantly greater in patients treated with Nplate compared to those in the placebo group in both studies (difference in proportion of splenectomized patients responding 38 percent (95 percent CI [23.4-52.8 percent; p>0.0001]); difference in proportion of nonsplenectomized patients responding 56 percent (95 percent CI [38.7-73.7 percent; p>0.0001]). In the placebo groups, no splenectomized patients and only one nonsplenectomized patient achieved a durable platelet response. The overall platelet response was 88 percent in nonsplenectomized patients compared to 14 percent in the placebo group; and 79 percent in splenectomized patients given Nplate compared to no splenectomized patients given placebo (p>0.0001). The data were published in the Feb. 2, 2008, issue of The Lancet.

• ImmunoGen Inc., of Cambridge, Mass., said partner Biogen Idec Inc., also of Cambridge, has submitted an investigational new drug application for BIIB015, triggering a $1.5 million milestone payment to ImmunoGen. BIIB015 comprises ImmunoGen's cell-killing agent, DM4, linked to Biogen Idec's Cripto-targeting antibody, and is in development by Biogen Idec for the treatment of solid tumors that express the Cripto antigen.

• MediciNova Inc., of San Diego, said data from a double-blind analysis of the first year of treatment from its two-year Phase II clinical trial of MN-166 in multiple sclerosis decreased the formation of black holes (permanent brain lesions believed to indicate the death of nerves in the brain) on magnetic resonance imaging. Data demonstrated that a 60-mg/day dosing regimen significantly reduced the proportion of new T1 gadolinium-enhancing or new T2 lesions identified at month 2 of the study that evolved into persistent black holes at month 10 compared to placebo (RR 0.63, p=0.011). Treatment with a 30-mg/day dosing regimen of MN-166 showed a trend toward reduced risk of new lesion evolution to persistent black holes compared to placebo (RR 0.735, p=0.074). Further results are expected in April.