13/11/2002
ReGen Therapeutics Plc (“ReGen”) reports that results from an independent long-term study of Colostrinin™ as a therapy for Alzheimer’s disease (AD) were recently published in an international scientific journal.
The study was conducted, independent of ReGen, by the team who carried out the original Polish studies of Colostrinin™ in the treatment of AD. As part of the agreement under which ReGen acquired the rights to Colostrinin™ from its inventors, the Polish team were entitled to continue to monitor the patients they had treated in their own early clinical studies. The authors of the published article include the scientists responsible for first isolating the Colostrinin™ complex from ovine colostrum and Dr Jerzy Leszek, the psychiatrist who conducted the first trials on AD sufferers at his clinic in Wrocław, Poland. Dr Jerzy Georgiades, a former director of ReGen, was also involved in the statistical analysis of the study, which was carried out at the end of the period over which the patients were observed.
The study itself was performed between 1995 and 1998 and the report of the study was published in Medical Science Monitor on 21 October 2002. Notwithstanding that the study was performed some time ago and prior to the commencement of ReGen’s recently completed clinical trial in Poland, ReGen reports that results presented in the published article describe how 33 patients were observed over a period of at least 16 months of therapy and includes data on 13 patients who joined the long-term study straight after having participated in one of Dr Leszek’s clinical trials and had therefore been treated continuously over a period of 28 months.
Quoting the results from the study, the authors reported that “Colostrinin™ induced slight but statistically significant improvement or stabilisation of the health status of the patients in the trial”. Statistical analysis was performed using only the Mini-Mental State Examination (MMSE) evaluation scale. As with Dr Leszek’s earlier clinical trials, the patients’ ADAS-cog scores were not recorded. Any adverse reactions to the therapy were reported to be “remarkably mild” and “subsided spontaneously within a short period of time (3-4 days)”, which reinforces the findings of ReGen’s own clinical trial in Poland, where no drug-related adverse events were recorded. The authors concluded that Colostrinin™ “is a very promising preparation” which can be used to “inhibit” or “retard” the development of AD.
Commenting on the Medical Science Monitor article, ReGen Chairman Percy Lomax said “We are extremely pleased that a long-term study on Colostrinin™, conducted by a group independent of ReGen, supports the findings of our own investigations into its efficacy in the treatment of Alzheimer’s disease. Whilst we were aware of the encouraging long-term effects that were being observed by Dr Leszek and his colleagues, ReGen did not participate in this study. However, we are very pleased to hear that some patients are reported to have continued to benefit from Colostrinin™ for over two years, which compares extremely favourably with the period over which existing registered drug treatments for Alzheimer’s disease are said to be most effective. Although we are not in a position to comment on the study itself, the results are very encouraging and further support our own theories that Colostrinin™ has the potential to become a truly effective, long term therapy for Alzheimer’s sufferers.”
For further information, please contact
Andrew Marshall
Marshall Robinson Roe
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