Fred
You might well be right. I looked around a little bit on the net and came up with the following. From the "NEJM release":
Progression of Phase III Development Program: Largest-Ever Trial in Crohn’s Disease Fully Enrolled
Four Phase III trials further evaluating the safety and efficacy of natalizumab in both Crohn’s disease and MS are underway. There are two trials in Crohn’s disease: ENACT-1 (Evaluation of Natalizumab in Active Crohn's Disease Trial - 1), the largest-ever study in Crohn’s disease conducted to date, is now fully enrolled with more than 850 patients and will evaluate clinical response and ability to induce remission; ENACT-2 (Evaluation of Natalizumab As Continuous Therapy - 2) will evaluate duration of effect. Investigators expect ENACT-2 to be fully enrolled shortly.
When the trials were initiated, Elan put out the following PR:
Elan and Biogen are also conducting two Phase III clinical trials in Crohn’s disease. The first Phase III trial, the largest to be conducted in Crohn’s disease, is a randomized, multi-center, placebo-controlled, double blind study of approximately 850 patients, which is designed to measure both the response and the ability to induce remission in patients at week 10 of administration of Antegren. The second randomized, multi-center, placebo controlled, double blind Phase III trial of approximately 300 patients is designed to evaluate the effect of Antegren on the duration of response and remission in patients with Crohn's disease
So, ENACT-1 was fully recruited at year-end and the primary endpoint is the patient's status at 10 weeks. Which for the latest enrolled patients in the study shouldn't be later than mid-March or just about now. Of course, after that Elan and Biogen will have to collect all data, unblind and do the evaluations and number-crunching. That should take a couple of months, I guess. So, perhaps there will be something early summer or so. Especially if there is any suitable conference to present data at, at that time.
As for ENACT-2. That seems to be a study taking somewhat longer to conclude.
While trawling the net I came across two currently recruiting studies.
This is interesting:
Safety and Efficacy of Natalizumab in Combination with Remicade in the Treatment of Crohn’s Disease
This study is currently recruiting patients.
Sponsored by
Elan Pharmaceuticals
Biogen
Purpose
The purpose of this study is to determine the safety, tolerability, and efficacy of natalizumab in individuals diagnosed with active Crohn’s Disease that are not in remission (CDAI greater than/equal to 150) and are currently taking Remicade. It is thought that natalizumab may stop the movement of certain cells, known as white blood cells, into bowel tissue. These cells are thought to cause damage in the bowel leading to the symptoms of Crohn’s disease
Remicade is - as I suppose you know - the standard biologic treatment for Crohn's today. Expected enrollment is 60 persons, so it is not a large study.
There is also a study looking at the agent when treating patients aged 12 - 17 years of age. More of a normal thing, I guess.
And just as a rounding off. The Prialt study seems still to be recruiting.
Erik |
