1:50AM Alexion Pharma present final data from Phase 2 studies of Soliris in patients with aHUS (ALXN) 45.52 : Co presents the final data from the two Phase 2 studies of Soliris as a treatment for patients with atypical hemolytic uremic syndrome. eculizumab. Consistent with previously announced data, both studies met their primary endpoints and key secondary endpoints with high levels of statistical and clinical significance. Separately, researchers presented for the first time findings from a retrospective clinical study of eculizumab in pediatric patients with aHUS. The study met its primary endpoint and key secondary endpoints with high levels of statistical and clinical significance, and findings were consistent with data reported at the 2010 American Society of Nephrology annual meeting. For the primary endpoint, platelet count increased from baseline through week 26 by a point estimate 73*109/L. Platelet count was normalized in 13 out of 15 patients (87%) who had abnormal platelets at baseline; 100% of patients who were analyzed per protocol achieved normal platelet count. With regard to secondary endpoints, 15 patients (88% of the total enrollment and 100% of those analyzed per protocol) achieved TMA event-free status, defined as at least 12 consecutive weeks of stable or increasing platelet counts, absence of plasma exchange/infusion, and no new dialysis.
1:43AM Alexion Pharma presents new data show renal impairment is strong predictor of early death in patients with PNH (ALXN) 45.52 : Co announces research that provides further insight into the clinical consequences of paroxysmal nocturnal hemoglobinuria, and positive impact of Soliris therapy on long-term outcomes. The study found that patients with PNH who have late-stage renal impairment had a significantly worse overall survival rate compared with PNH patients without renal impairment. Researchers analyzed data from 301 patients enrolled in the National Data Registry in South Korea to assess the impact of late-stage renal impairment in patients with PNH: 16% of patients had a history or presence of late-stage renal impairment, and these patients accounted for 35% of patient deaths in the registry. Patients with late-stage renal impairment had significantly worse overall survival compared with PNH patients with no impairment. A multivariate regression analysis showed that renal impairment was a strong predictor of mortality.
surf's up......crikey
