AGM Statement
11 June 2003 - 12:08AM
UK Regulatory
RNS Number:0814M
ReGen Therapeutics PLC
10 June 2003
ReGen Therapeutics Plc
AGM STATEMENT
10th June 2003
PROGRESS ON PRODUCT AND CORPORATE DEVELOPMENT
ReGen Therapeutics Plc (the "Company") announces today, at its Annual General
Meeting, the following progress and update statement.
ColostrininTM
It is now almost a year since we announced the positive outcome of our clinical
trial of ColostrininTM in the treatment of Alzheimer's disease. 106 patients were
treated over 30 weeks and the results demonstrated efficacy in a significant
proportion of patients treated, with no safety concerns. The full findings of
the study have recently been submitted for publication in a peer reviewed
international medical journal.
At our strategy update meeting held on 10th December 2002 we stated our
intention to concentrate our immediate efforts with the ColostrininTM project on
a number of product development issues. It is our opinion that these issues need
to be resolved before we will be able to attract a development and
commercialisation partner, on terms reasonable to the Company, and move to the
next stage of clinical development. We remain on course to achieve resolution of
these issues during the second half of 2004.
Our general progress since completion of the clinical trial can be summarised as
follows:
* Mode of Action
Understanding the mode of action of a drug therapy enables several things to be
achieved. Quality control assays and laboratory models most representative of
clinical conditions can be developed, primarily for use in controlling the
manufacturing process. Just as importantly, however, a better understanding of
the mode of action may also allow the rational propososal of other medical
conditions where the therapeutic might be of use.
Ongoing work with our collaborators at the University of Texas Medical Branch,
Galveston, USA has already started to reveal at least two ways in which
ColostrininTM might achieve its clinical activity, suggesting that it may both
act as a modulator of oxidative stress and have some regulatory effect on
apoptosis.
Oxidative stress is a general term for the build-up of harmful oxidising
materials as a result of normal/abnormal cell metabolism. This build-up
gradually overwhelms the processes which normally neutralise these materials,
leading to the damage of important molecules (e.g. enzymes) and the impairment
of their function, ultimately leading to disease. Oxidative stress has recently
been implicated as a key feature in the development of neurodegenerative
diseases such as Alzheimer's disease.
Apoptosis is the mechanism of cell death in normal cells, when they reach the
end of their life expectancy. However, premature apoptosis is also triggered by
many disease processes. The work on the action of Colostrinin in relation to
apoptosis was presented at an international conference on Alzheimer's disease
last year and has recently been published in the Journal of Molecular
Neuroscience.
* Potency Assays
Developing a better understanding of how ColostrininTM might work is enabling us
to develop several new in-vitro assays, which may better represent the clinical
activity of ColostrininTM. The most advanced of these have already shown evidence
of a 'dose-response' relationship, offering the possibility that higher doses of
ColostrininTM might lead to a better clinical response.
We are now starting to validate the most promising of these assays. Once this
work is completed, the assays should be able to be used as a quick and
relatively inexpensive way to compare the potency of different ColostrininTM
preparations and its constituent peptides.
* Manufacturing
All batches of ColostrininTM used to date have been made using a relatively
inefficient, small-scale process and using non-standardised ovine colostrum as
the raw material.
We are now well advanced with the development of a more controllable and more
efficient manufacturing process, which we believe can be more easily adapted to
an industrial scale. We have shown that ColostrininTM made by the new process and
using standardised bovine colostrum is physico-chemically the same as that made
by the original process using ovine colostrum and we are currently testing the
new preparations for biological activity, using the new assays and laboratory
models. In anticipation of a positive outcome in these tests, we are about to
enter into collaboration with a US-based colostrum processor to scale-up and
industrialise this process.
* Nutraceutical potential
Following our December 2002 strategy update and an independent review of the
nutraceutical potential of ColostrininTM we have decided that ColostrininTM could
be developed as a nutraceutical in parallel with its continued development as a
pharmaceutical product. We believe that development of ColostrininTM as a
nutraceutical product offers the potential of earlier-than-planned revenues for
the Company.
* Other uses for ColostrininTM
A better understanding of Colostrinin'sTM 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
what proteins are increased or decreased in cells when exposed to ColostrininTM.
If proteins known to be associated with particular diseases are found to be
modulated by ColostrininTM, these findings may warrant further, more specific,
investigation. Based on preliminary findings from research work already
conducted, we are in discussions about beginning screening ColostrininTM for
anti-cancer activity, using a standard panel of cancer cell-lines.
Corporate Development
* Funding
We have seen a number of developments in our funding position since December
2002. Our broker, Hoodless Brennan and Partners, has placed #395,000 of new
equity with new and existing clients of their firm. We regard this as very
encouraging, as we believe it is a sign there is a renewed appetite for
biotechnology equity, which is crucial to us in the short term. We have also
realised #125,000 from the sale of shares in one of the investment trusts in
which we have a holding. We will continue to be innovative in our funding.
* Acquisitions
We continue our active search for potential corporate acquisitions that will
provide sources of revenue for the Company in the mid-term.
Conclusion
We remain confident in the potential for the success of the ColostrininTM project
and are encouraged by the support from investors in a difficult climate for the
sector. Our interest in allied areas is aimed to provide solid support for this
core activity.
On a final, personal note, I would like to thank all our employees, consultants
and advisors for the way in which they have contributed to moving the Company
forward over the last year.
Percy Lomax
Chairman
Further information:
Andrew Marshall
Marshall Robinson Roe
020 7489 2033
This information is provided by RNS
The company news service from the London Stock Exchange
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