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Biotech / Medical : Biotech failure, 2002 -- Ignore unavailable to you. Want to Upgrade?

To: nigel bates who wrote (98)	7/30/2002 10:46:49 AM
From: keokalani'nui	Read Replies (1) \| Respond to of 130

Maybe not total failure. Very disappointing that the steroid withdrawal study did not show significance. Celltech Announces Results From CDP 571 Phase III Studies in Crohn's Disease SLOUGH, England, July 30 /PRNewswire-FirstCall/ -- Celltech Group plc (NYSE: CLL; London: CCH) today announced outline results from a Phase III study undertaken to evaluate CDP 571 as a new treatment for active Crohn's disease, and also from a further Phase III study in steroid-dependent Crohn's disease patients. The principal study, involving 400 patients, assessed the efficacy and safety of CDP 571 in achieving acute clinical responses, and in maintaining responses over 28 weeks. CDP 571 was administered intravenously, at 8-weekly intervals, at a dose of 10mg/kg. Treatment-related benefit was assessed by the numbers attaining a significant reduction in Crohn's disease activity index (CDAI) or disease remission. CDP 571 treatment achieved statistically significant efficacy in respect of a range of acute and 28-week clinical endpoints, which are summarized below. The 28-week combined primary endpoint (CDAI reduction > or = 100 points and/or remission) was not reached when analyzed on an intent to treat (ITT) basis, but did achieve statistical significance on per protocol data analysis. Importantly, the product displayed an excellent safety profile, with very low immunogenicity observed on repeated dosing. Celltech has also conducted a pilot open label study in patients who are hypersensitive to infliximab, which demonstrated that CDP 571 is well tolerated in these patients. CDP 571 also demonstrated encouraging efficacy in relation to acute endpoints in this study. Celltech plans to seek guidance from US and European regulatory authorities with regard to the database likely to be required for CDP 571 marketing approval for acute treatment of active Crohn's disease, and for its ongoing clinical management on an as-needed basis. Celltech and Biogen, Inc. (Nasdaq: BGEN - News) will review their collaboration on CDP 571 following these discussions with the regulatory authorities. Further details of the results are as follows: * CDP 571 showed promising activity against a range of acute endpoints important in the management of disease flares. The number of patients attaining the combined endpoint of a CDAI reduction of > or = 100 points and/or remission was statistically significant at week 2 (p = 0.011) and week 4 (p = 0.014) on an ITT basis. * Over the 28-week study period CDP 571 achieved a series of clinical responses relevant to the longer-term management of active disease. The response across the 28-week period was significant (p = 0.02) compared to placebo, as assessed by comparing the AUCs (areas under the curves). The combined primary endpoint at 28 weeks (CDAI reduction > or = 100 points and/or attainment of remission) was not met when analyzed on an ITT basis, although there was a trend to significance (p = 0.067), but was achieved with a per protocol analysis (p = 0.048). The second study, conducted over 35 weeks, involved over 270 steroid-dependent patients, and assessed the ability of CDP 571 to enable safe withdrawal of steroids from these patients while maintaining disease remission. Whilst CDP 571 enabled 55% of patients to discontinue steroid usage at the end of the treatment period, there was no significant difference when compared with the placebo group, which displayed an unusually high response rate. Further analyses are ongoing to determine whether CDP 571 treatment demonstrated significant effectiveness in any patient sub-groups. Very importantly, CDP 571 was well tolerated in both studies, with an excellent safety profile. A very low frequency of immune response was detected in patients over the entire treatment period despite repeated dosing. The overall rates of adverse events were very similar in CDP 571-treated and placebo groups, with no significant differences, including infection rates. In total over 1,000 patients have been treated with CDP 571, with most patients having been treated for 6-12 months.