LONDON - ReGen Therapeutics plc raised £2.1 million (US$3.5 million) from institutional and private investors to commercialize the Alzheimer's disease treatment Colostrinin, developed over the past 20 years at the Institute of Immunology at the Academy of Science in Wroclaw, Poland.

The majority of the 5 million shares, offered at £0.50 each, have been taken up. The company is valued at around £16 million.

From early this month the shares will be traded on OFEX, the unregulated trading facility via which member firms of the London Stock Exchange can deal in unlisted and unquoted stocks. A move to the Pan-European exchange, Easdaq, is planned in six to nine months.

ReGen, based in London, is acquiring rights to Colostrinin, a proline-rich polypeptide complex derived from ewe's colostrum (the first component of the milk expressed after giving birth). In double-blind clinical trials carried out in Poland over the past three and a half years, the progression of Alzheimer's disease was halted in all cases. Some patients also showed significant improvement in social functioning and short-term memory. None of the 16 patients in the treated group died during the study, and there were no side effects. Colostrinin is orally available.

The German company Rentschler Biotechnologie GmbH, of Laupheim, is taking a 20 percent holding in ReGen, and will increase its stake to 25 percent if the European Medicines Evaluation Agency (EMEA) approves the treatment. Rentschler will be responsible for developing a large-scale production facility for Colostrinin. ReGen plans to apply for registration of the drug in Poland first, and Rentschler will supervise the setting up of a production facility and will manage the registration process in Poland.

The company said Polish authorities are keen to move Colostrinin forward, and ReGen expects to license other drug candidates from the Polish Academy if it succeeds with Colostrinin.

Colostrinin was first isolated from ewe's colostrum in 1974 by a group of scientists at the Polish institute. In its prospectus, ReGen says Colostrinin has since been shown to have immunoregulatory properties, and to enhance the production of cytokines such as interferon gamma and tumor necrosis factor. Some studies have indicated that these cytokines inhibit the formation of amyloid beta, a primary component of the abnormal protein fibrils that accumulate in the brains of Alzheimer's sufferers.

However, ReGen acknowledged that the clinical trials conducted to date would not meet the standard required for European or U.S. approval, and more preclinical study is also needed.

With the funds it has raised, ReGen now intends to initiate a multicenter, open-label trial on 80 patients in Poland and Germany. The protocol will be formulated by Rentschler to ensure it meets the registration requirements of the Polish authorities and satisfies the EMEA's criteria for a dose-ranging study. The study will be completed in 18 months. *

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