16/10/2000
Alzheimer’s disease drug developer, ReGen Therapeutics plc, has strengthened its management team and organisation pending the results of its clinical trial currently being carried out in Poland, where the treatment, Colostrinin, was developed.
A subsidiary company is being opened in Poland to aid liaison with the scientific and medical community in Poland, the Polish Regulatory Authorities and to plan for drug distribution in Poland subject to the treatment being approved. The subsidiary company will be managed by Pawel Lupinski, formerly a senior executive in Poland with international drug group Eli Lilley, where he had product marketing and government relationship roles.
Progress is also being made in developing a commercial scale manufacturing process for Colostrinin and the Company has signed a Development Agreement with AEA Technology PLC, aimed at determining the steps required to achieve a larger scale manufacturing process. Work is anticipated to be completed during 2001. AEA Technology is a £360 million turnover innovation group listed on the London Stock Exchange techMARK 100 index. As part of is broad technology base it provides specialist expertise to assist pharmaceutical companies in bringing products to market.
In parallel with these developments, the Company has also identified and appointed experienced Regulatory and clinical Consultants in the UK, broadening the skills and expertise available to the in-house management team.
The Company has also appointed Ernst and Young as Nominated Adviser in accordance with the rules of the Alternative Investment Market (AIM).
NOTES
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 trial follows 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. All six trial centres have received a favourable response from their local Bio-Ethics Committees, and around one third of the study group have started treatment. 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 last year, are being conducted in six clinical centres and will involve 90 patients. Interim results of the trial are anticipated early in 2001.
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.
Prior to the Company being admitted to the Alternative Investment Market earlier this year Mike Harvey, formerly director of UK manufacturing of Medeva Pharma Ltd, a subsidiary of Medeva Plc, was appointed Managing Director. Prior to Medeva he worked in senior roles at Celltech and Glaxo. Around the same time David Gration, deputy chairman of Protherics, joined the board. He had previously held senior position with The Boots Company, Wyeth Laboratories and Celltech.