-- The NEW Official Alizyme Thread! --

Does anyone know what is happening regarding AZM's PIII COLAL-PRED acute trial?

Nomura stated in from March 2005 that recruitment was expected to commence during Q3 2005:

"15/3/2005:

From Nomura Morning news & Views

Alizyme has announced that it has been granted permission to start a Phase III clinical trial of COLAL-PRED in Europe by the UK Medicines and Healthcare products Regulatory Agency (MHRA). The aim of the trial is show that COLAL-PRED is noninferior to standard prednisolone but has a better side effect profile in treating ulcerative colitis. The clinical design and endpoints will be as follows:

1. The trial will involve up to 670 patients suffering from acute ulcerative colitis with a Disease Activity Index (DAI) of between 5-10 (i.e. moderate to severe patients).

2. The patients will be divided into four parallel groups, three taking doses of COLAL-PRED and one taking systemic prednisolone. The trial will be randomised and double blind.

3. The primary endpoint will be the number of patients responding with a fall in DAI of 3 or more points. A secondary variable will be the percentage of patients going into remission (i.e. achieving a DAI of 0-1). Safety will be primarily measured by looking at patient’s morning blood cortisol levels (a correlate of systemic steroid toxicity), with the agreed end point being the percentage of patients with cortisol levels falling below 150ng/ml.

• Alizyme expects to begin the trial in Q3-05. If recruitment is at the expected pace, then first data should be available by end-2006".