Corporate Profile: THE MIRACLE WORKER

Alzheimer's, as anyone who has cared for an elderly sufferer knows, is a cruel disease that robs its victims of their memory, their language and their personality. It strikes without warning and apparently without reason, and those affected become confused, agitated and eventually incapable of caring for themselves as their brain cells deteriorate.

It is also a disturbingly random condition, more common among older people but affecting men and women in roughly equal proportion. There is no obvious genetic predisposition to senile dementia and no compelling evidence that it is encouraged by lifestyle choices such as smoking or drinking. In any given year, a study shows, around 1 per cent of the population will develop a disease for which scientists have searched in vain for a possible cure.

But last month an AIM-quoted company called ReGen Therapeutics quietly confirmed that initial clinical trials of a product called Colostrinin have proved that it might be possible to arrest, and even reverse, the symptoms of Alzheimer's disease without significant side- effects. The treatment, produced from colostrum or the first milk produced by mammals after giving birth, is thought to stimulate the immune system and protect human brain cells by dissolving the abnormal proteins that build, in the central nervous systems of Alzheimer's patients.

"The data is very encouraging," says ReGen's chief executive, Mike Harvey, who joined the company shortly after the trials of Colostrinin against a placebo began in November 1999. "We know there are no safety issues and there are clear differences between the two groups of patients. We are looking at the relative rates of deterioration and we are seeing a trend where those receiving Colostrinin are deteriorating significantly less than those who are not. In some cases the progress of the disease appears to have stopped." One person taking Colostrinin, administered as a pill, is understood to have improved so markedly he is back at work.

The trials, which involve testing patients on their ability to recognise and remember colours, shapes and everyday objects, also indicate Colostrinin could deliver bigger and more sustainable improvements than other drugs. Pfizer's Aricept, the market leader with annual sales of pounds 750m, produces comparatively modest improvements. Tacrine, made by Warner-Lambert, has been linked with potentially toxic side-effects on the liver. Colostrinin, essentially a natural substance derived from sheep's colostrum, appears to be effective and safe. "In some of our earlier trials there were some indications that some patients suffered from insomnia but the symptoms didn't persist," Mr Harvey says.

ReGen's results will not be conclusive until the end of the year, but since the trial's interim results were released last month the company's share price has climbed about 50 per cent to 21p as investors eye the potential market for an effective Alzheimer's treatment. An estimated 10 million people in Europe, the United States and Japan suffer from it and by the middle of the century the worldwide figure might be closer to 100 million, some projections show. At present, Colostrinin could generate global sales of up to $5bn (pounds 3.5bn) a year, which could grow substantially as the population ages. This week ReGen is valued at about pounds 15m on the stock market, but some analysts believe that could rise to pounds 150m if Colostrinin's final trials prove successful.

ReGen has already made significant progress since the company was launched four years ago by Jerzy Georgiades, a Polish immunologist, with a lawyer and investor Malcolm Beveridge and adviser Martin Small, all of whom are still with the business. The same year, ReGen acquired the intellectual property rights to Colostrinin from the Ludwik Hirszfeld Institute of Immunology, a research centre that had been investigating the properties of Colostrin for nearly 25 years. The company has raised more than pounds 6.3m through share placings and brought in a handful of experienced directors including Mr Harvey, a former new development director with the pharmaceuticals group Medeva, and Percy Lomax, the executive chairman, who worked for Glaxo and Fisons before becoming a City analyst and corporate adviser. Rentschler, a German pharmaceutical company, owns nearly 20 per cent of the company and Jupiter Asset Management holds an 8 per cent stake. What swayed Rentschler, Jupiter and the others is that ReGen's treatment acts in a way that is very different to rival drugs engineered in a laboratory. "We think the product has multiple actions, and the designer molecules that drug companies produce are by their nature targeted at a single point of intervention in the disease," says Mr Harvey. "Our product is a naturally occurring mixture of peptides with different properties. We know some intervene in the immune response, and we know some have anti- oxidant properties." Some of the symptoms of Alzheimer's are thought to be caused by abnormal proteins deposited in the brain, which prevent its receptors working properly. "When you do a post- mortem on a sufferer the brain is absolutely clogged with beta-amyloid protein," Mr Harvey says. "We believe some of Colostinin's peptides will combine with it to inhibit its growth."