11/04/2001
ReGen Therapeutics Plc reports that the International Steering Committee, which is supervising its 90 patient, multi-centre, double blind placebo-controlled study of Colostrinin™ in the treatment of Alzheimer’s disease, has recommended that the study be continued to its end-point.
Under the protocol for the study, the Committee carried out an interim analysis of the data generated by the first 45 patients to complete the initial phase of the study.
The Committee’s findings confirm that there are no Colostrinin™-related safety issues of concern in the study and that there was an encouraging trend towards demonstrating efficacy of Colostrinin™ in those patients receiving it, compared to the placebo group. Based upon these findings, the Committee recommended that the study be continued. It further recommended that up to 20% more patients should be enrolled, in order to increase the power of the study. The Company intends to follow these recommendations and anticipates completion of the study around the end of this year.
Mike Harvey, ReGen’s Chief Executive said, “the comments of the Committee are encouraging at this stage in our development. The expansion of the clinical trial, by the relatively small number of patients involved, should have no significant time or cost implications”.
Notes to editors
Colostrinin is a proline-rich polypeptide complex isolated from ovine colostrum in 1974 by a group of scientists working in Poland. Colostrum is mammals’ first milk after birth of offspring and has immunomodulatory functions that protect a newborn against a variety of diseases. Alzheimer’s disease is characterised by the accumulation of abnormal protein fibrils, including senile plaques, causing selective neuronal loss in the central nervous system. The primary components of senile plaques are insoluble aggregates of a peptide called amyloid beta. In addition, an abnormal level of iron is witnessed in the brains of Alzheimer’s disease patients. This is thought to be oxidised in the brain, giving rise to free radicals which then go on to damage cells.
In laboratory trials, Colostrinin has been shown to promote the scavenging of free radicals in brain tissue, induce IFN Gamma which inhibits amyloid beta formation and to promote the differentiation and regeneration of human brain cells. Compared to most other treatments for Alzheimer’s disease which are in most cases known to have significant serious side effects, tests to date indicate only one significant side-effect, insomnia, which can be treated
The current Polish clinical trials are being conducted at six centres. These trials follow five years of initial clinical trials which have shown a good therapeutic effect with a significant percentage of patients treated showing stabilisation, and in some cases improvement, over a period of several years. The clinical trials protocol provides for the data to be reviewed by the Steering Committee after 42 patients have completed three treatment cycles. Following a ruling by the Polish Authorities the initial study is being conducted in double blind placebo format and converting to open label format at the interim stage. The Polish Authorities reasoned that is would be unethical to deprive a substantial group of frail elderly treatment by prescribing a placebo throughout the trial, given the successful treatment history during the initial clinical trials.
The trials are being monitored by Rentschler Biotechnologie GmbH & Co.KG, an early pioneer in the research of interferon, and a substantial shareholder in ReGen. The trials, which were registered with the Polish Central Registry for Clinical Trials, in November 1999, are being conducted in six clinical centres and involve 90 patients.
Chairman of ReGen is Percy Lomax who has over 30 years experience in working in, or with the pharmaceutical industry since he joined Glaxo in 1967. Chief scientific Officer, Jerzy Georgiades was a Rockefeller Fellow of the Department of Epidemiology and Public Health at Yale University School of Medicine.
For further information please contact:
Andrew Marshall
Marshall Robinson Roe
Tel. No. 020 7489 2033