ReGen's Colostrinin trials continue

ReGen Therapeutics of the UK reports that its study of colostrinin fortreating Alzheimer's disease will continue to its endpoint on the recommendation of the trial's steering committee. The panel carried out an interim analysis of the data generated from the first 45 patients in the 90-patient, multicenter, placebo-controlled study and found an encouraging trend towards demonstrating the efficacy of colostrinin in treated patients compared to those on placebo, and also confirmed there were no safety issues of concern.

To increase the power of the study, the committee has recommended that 20% more patients will be enrolled, and it may convert to an open-label format. ReGen expects to complete the study, which follows five years' of initial clinical trials that demonstrated good therapeutic effects and stabilization of AD symptoms with the drug, at the end of 2001.

Colostrinin, a proline-rich polypeptide complex, is derived from ovine colostrum which has immunomodulatory functions. It has been shown to promote the scavenging of free radicals in the brain, induce interferon gamma and promote the differentiation and regeneration of human brain cells. Most treatments for AD have serious side effects, but colostrinin has been linked to only one significant adverse reaction, insomnia, which can be treated, said ReGen.