20/07/2000
ReGen Therapeutics which registered its trial for Colostrinin, the Alzheimer’s disease treatment derived from ovine colostrum, with the Central Registry of Clinical Trials in Warsaw, Poland in November last year reports continuing progress with the trials. This late stage clinical trial follows five years of using the therapy to treat Alzheimer’s patients in Poland.
The first phase of the trial involves 90 patients in double blind placebo format with plans to convert to open label format at the interim stage. The trials were originally being conducted in three clinical centres and all three centres received favourable responses from their local Bio-Ethics Committees. Around one-third of the study group have now commenced treatment. As recently announced, to speed up patient recruitment the company has extended the trial to further centres.
The clinical trial protocol provides for the data to be reviewed by the Steering Committee after 42 patients have completed three treatment cycles. The Company expects to reach this point before the end of the year. This data will enable the Committee to determine whether to complete the study on a placebo controlled or open label basis. The Company will publish the Committee’s findings subsequently.
Progress has also been made in identifying some of the steps that may allow for the commercial production of Colostrinin. Many of the key regulatory targets have now been identified and specific project work is being commissioned to address these issues.