Guest guest Posted December 18, 2006 Report Share Posted December 18, 2006 Genmab Announces Positive Interim Data for the HuMax-CD20 Phase II RA Study http://www.therapeuticsdaily.com/news/article.cfm?contentvalue=1170052 & contentty\ pe=sentryarticle & channelID=29 COPENHAGEN, Denmark - Genmab A/S announced today positive results from an interim analysis of the first 100 patients in the ongoing Phase II rheumatoid arthritis (RA) study. A statistically significant proportion of patients on active treatment obtained a 20% improvement of the American College of Rheumatology (ACR) response compared to patients treated with placebo. Correspondingly, in all groups treated with HuMax-CD20, a greater proportion of patients benefited from moderate or good EULAR responses compared to placebo. Rates of overall adverse events were comparable between the 3 groups of patients receiving HuMax-CD20 these were primarily infusion related and do not limit plans for continued development. Serious infections among treated patients were confined to one event of bronchopneumonia in the 300 mg dose group. With this data in hand, Genmab will start planning Phase III studies. These studies are expected to begin in 2007. " The interim data are comparable to the Phase I/II RA data trial released earlier this year and support our plan to move into Phase III with HuMax-CD20 in RA, " said N. Drakeman, Ph.D., Chief Executive Officer of Genmab. " Our fully human antibody should be suitable for treating chronically ill patients and we look forward to continued development of this potential alternative to available treatments. " There are 226 patients enrolled in the Phase II study which completed accrual in September. Genmab expects to present results for the full Phase II study during the first half of 2007. This analysis was carried out to assist in decision making and planning for the expected Phase III studies in RA. About the study The study is a double-blind, randomized, placebo controlled, multicenter Phase II trial for patients with active RA who have previously failed one or more DMARDs. Patients were randomized to one of 4 treatment groups (300 mg, 700 mg or 1000 mg of HuMax-CD20 or placebo). Patients were permitted to continue therapy with stable doses of methotrexate and low dose prednisolone was also allowed. ACR and EULAR responses were assessed in the primary intention-to-treat efficacy population at 24 weeks. Quote Link to comment Share on other sites More sharing options...
Recommended Posts
Join the conversation
You are posting as a guest. If you have an account, sign in now to post with your account.
Note: Your post will require moderator approval before it will be visible.