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Company Interview Excerpt
PERCY LOMAX - REGEN THERAPEUTICS PLC (RGT.L)


Full article published: 07/28/2003


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TWST: Shall we start with a brief introduction to ReGen Therapeutics, perhaps including an historical overview and then bringing us to date with how you are positioned today?
Mr. Lomax: ReGen was founded in February 1998, went to the OFEX market which is an unlisted market, in December 1998 raising £1.45 million. We then went to the Alternative Investment Market (AIM) of the London Stock Exchange in March 2000, which is a publicly listed market, raising £5 million. That's how we evolved into the public arena. We have remained on the AIM market and completed some additional fund raising since then. With regard to the business, the crucial point is that we have finished our clinical trial (RG010) in Poland and it reached the statistical end point which showed there was a 98% chance that it improved cognitive function as measured by ADAS COG which is the normal measure. The clinical trial, while conducted in Poland, was conducted under the aegis of a German clinical research organization and the statistical data was evaluated by a professor at the University of Ulm. So while it was not done according to the same box-ticking requirements of FDA or the European Medicine Evaluation Agency standard, we do have a scientifically valid trial which showed the product had efficacy in Alzheimer's Disease. The tablets used in the trial were a very low dose and there were no toxicity or safety issues, which of course is not true of any of the Alzheimer's drugs on the market. Therefore, since the trial, which ended in May 2002, we have been looking at whether we may in fact have a use in areas such as mild cognitive impairment and even a nutraceutical type usage for a slightly differently produced product. We are carrying out all the other scientific bits and pieces, the tick boxes, which the Western agencies require. This had not been done prior to this for the simple reason that I think the then Chief Executive and the Chief Scientific Officer were concentrating on the trial. They left us in the summer of last year, and I have concentrated since then on doing the further development work and tidying up. When we have completed full scale manufacturing scale up, we shall then examine the dosage again because with no toxicity or safety issues in theory we should be able to expand the dosage to increase efficacy. Finally, because we can see there is a problem with funding what you might call blue sky biotech, we have decided on an acquisitive route whereby for paper we will take over small companies with revenue streams which are not in drug discovery but in health care. This would provide a revenue base and make our investors more comfortable, who are still looking at a 2006 launch for the product and we are not going to get any deals done until I suspect 2004. On the management side we reorganized last summer; the Chief Scientist and the Chief Executive left; we shut our Polish office; we halved the size of the London office; and overheads on an MAT basis came down from £1.5 million to £800,000. The managers are now targeted on financial lines to achieve certain objectives. We have also been doing a considerable amount of work with the University of Texas Medical Branch and interesting results have been coming out of there. In particular, the mode of action study which was published at a conference in Barcelona in the autumn. That was Marian Kruzel and the team at the UTMB. We have recently published the results for the work on the action of Colostrinin in relation to apoptosis in The Journal of Molecular Neuroscience. We are now starting to validate the most promising of the potency assays. We believe that Colostrinin's mode of action suggests that it might be of benefit in medical conditions other than just Alzheimer's Disease. We are therefore in the process of commissioning a general proteomics analysis to see which proteins react when exposed to Colostrinin. We are also in discussions about entering into a collaboration with a US based colostrum processor to scale-up the manufacturing process. There is obviously further work that needs to be done there, but we are proceeding with that, and of course we are proceeding with our patenting work worldwide. So all in all, we have achieved what we set out to do, although somewhat more slowly than we thought we would. But if I had been asked five years ago whether I would settle for where I am now, I would have probably said yes.

 

Tickers included in this excerpt: RGT.L

 

For more information call (212) 952 7433. The Wall Street Transcript does not endorse any of the comments made by interviewees, and does not make stock recommendations.