By Nuala Moran
BioWorld International Correspondent
LONDON ¿ ReGen Therapeutics plc said it conditionally placed 10.5 million new shares at 10 pence per share, raising just over #1 million (US$1.42 million) to complete clinical trials of Colostrinin, its treatment for Alzheimer¿s disease under way in Poland, and to scale up the manufacturing process.
The placing is subject to shareholder approval at a meeting Nov. 5. Chairman Percy Lomax said, ¿I am delighted that the company has managed to achieve this level of conditional commitments in the current difficult market conditions.¿
The money is needed to fund an expansion of the trial of Colostrinin, an orally available, proline-rich polypeptide complex derived from ovine colostrum. In an interim review in April, the international committee overseeing the trial said that although ¿the data showed an encouraging trend towards efficacy,¿ the difference between the Colostrinin-treated group and the placebo group was not statistically significant.
ReGen, based in London, said earlier this month that it has almost completed the enrollment of additional patients. It expects to assess the status of the trial early next year, based on access to unblinded data.
ReGen was set up in November 1998 to commercialize Colostrinin, developed over 20 years at the Institute of Immunology at the Academy of Science in Wroclaw, Poland. The compound has immunoregulatory properties and has been found to enhance the production of cytokines, such as interferon and tumor necrosis factor. Some studies have indicated these cytokines inhibit the formation of amyloid beta, a component of the abnormal protein fibrils that accumulate in the brains of Alzheimer¿s sufferers.
In double-blind trials conducted before ReGen acquired the rights, 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 three-and-a-half-year trial, and there were no side effects. However, this trial did not meet the standard required for European or U.S. approval, and ReGen also was required to carry out more preclinical work.
ReGen raised #1.45 million when it was founded in 1998, and a further #300,000 the following year. In March 2000 it moved onto London¿s Alternative Investment Market, raising #5 million in the process.