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Nephropathy

April 16, 2007

Pharmacopeia announced positive results from a phase I trial of PS433540 for the treatment of hypertension and diabetic nephropathy. This randomized, placebo-controlled, dose-escalation trial enrolled healthy subjects who were placed into six groups. Each group was comprised of eight individuals, with six receiving PS433540 and two receiving placebo. Treatment was administered in doses ranging from 20 mg to 1000 mg and the doses were increased for each successive group. Treatment was well tolerated across all six doses administered. PS433540 possessed linear pharmacokinetics and a half-life consistent with once daily administration. Based on the results, Pharmacopeia plans to initiate multiple ascending dose trials later in 2007.

November 21, 2005

CuraGen reported positive results of a phase I trial of CR002, their monoclonal antibody for the treatment of kidney inflammation. Trial data indicated a positive safety profile, with no serious adverse events reported and good overall tolerability. Pharmacokinetic data indicated that meat elimination half-life was 20.1 to 34.2 days, and pharmacodynamic results indicated binding to the antibody's target molecule (platelet derived growth factor-D) for durations exceeding 20 days. This open- label placebo-controlled study enrolled 40 healthy volunteers, who received one of five single doses of the drug (0.3 mg/kg to 30 mg/kg) or placebo, with subsequent 3 month observational follow-up.

Roche issued positive results of a phase II extension study of CERA for the treatment of anemia in chronic kidney disease (CKD) patients not yet on dialysis. Weekly (11.3 g/dL), once-every-two-weeks (11.4g/dL) and once- every-three week (11.7 g/dL) doses of the drug met their primary efficacy endpoint of maintaining hemoglobin levels between 11 and 12 g/dL throughout the treatment period. The drug was generally well tolerated: the most frequently reported adverse events were urinary tract infections, gout, hypertension, peripheral edema, and insomnia. This open-label study enrolled 51CKD patients, who received treatment with subcutaneous doses of CERA once weekly, once every 2 weeks or once every 3 weeks for 54 weeks.

Speedel reported positive results of a phase IIb trial of SPP301 for the treatment of diabetic nephropathy. Study data indicated that the drug significantly reduced urinary albumin excretion rate at all trial doses compared to placebo (p<0.001), with the greatest reductions noted in the two highest trial doses. Total cholesterol scores were also significantly reduced at all doses (p<0.001). Rates of proteinuria were reduced by 30% on top of standard therapy. This randomized, placebo- controlled, double-blind, parallel design study enrolled 286 patients, who received one of 4 doses of SPP301 (5 mg, 10 mg, 25 mg or 50 mg) or placebo once daily for 12 weeks, in addition to standard therapy.