22/03/2002
ReGen Therapeutics Plc announces that further interim data from the first phase of its current clinical trial of Colostrinin™, a potential therapy for Alzheimer’s disease, continues to show an encouraging trend towards efficacy.
The trial involved 106 patients at six clinical centres in Poland. The first phase of the trial was double-blind, placebo-controlled, where half of the patients received Colostrinin™ for 15 weeks and the other half received a placebo. Neither the patients nor the clinicians treating them were aware of whether the active material or the placebo was being administered. Following completion of the first phase, a final phase is now ongoing where all remaining patients are receiving “open-label” Colostrinin™ for a further 15 week period.
The averages of the results now analysed show that a beneficial effect was seen in patients receiving Colostrinin™ to the extent that their rate of deterioration due to Alzheimer’s disease was slower than the rate in the placebo group. Whilst the findings did not achieve statistical significance at this interim stage, they were consistent across all seven of the variables measured and the greatest effects were seen in the ADAS-cog and IADL measurement scales. ADAS-cog measures cognitive function, whereas IADL measures the ability of older people to perform normal everyday activities. These are two of the more significant measurement scales in the assessment of Alzheimer’s disease. The data further confirms that there are no current concerns over the safety, toxicity or side effects of Colostrinin™.
Scientific research conducted by ReGen and its contractors suggests that Colostrinin™ may be acting to modify the Alzheimer’s disease process. The Company’s scientific team have postulated that Colostrinin™ may act as an anti-oxidant, may prevent the formation of or dissolve Amyloid β plaques and may modulate the immune system. Oxidative stress is thought to be a major factor contributing to the steady decline seen in Alzheimer’s disease sufferers and the presence of plaques is a strong post-mortem indicator of the disease.
The Company is continuing to analyse the full data from the first phase of the trial and will then progress to the analysis of data from the final phase, following the completion of the last patient’s treatment in mid-May. A further announcement following that analysis will be made in due course. Assuming a positive outcome to this trial, further clinical trials and other studies will be required before any application for regulatory approval can be submitted.
Mike Harvey, ReGen’s Chief Executive said “We are extremely encouraged by these clinically interesting results. If the safety and efficacy profile, shown in the first phase of this trial is maintained in its final phase, then Colostrinin™ has the potential to be one of the first therapies for Alzheimer’s disease that will offer long term benefits, as opposed to the symptomatic relief which is currently offered by the majority of drugs on the market for this disease. We continue to evaluate our options for further clinical development.”
For further information, please contact:
Lisa Baderoon
Mobile No: 07721 413 496
Buchanan Communications
Telephone No: 020-7466-5000