05/02/2007
STUDAY SHOWING THAT REGEN’S COLOSTRININ(TM) INCREASES LIFE-SPAN AND NEUROLOGICAL
PERFORMANCE IN MICE TO BE PRESENTED AT ALZHEIMER’S DISEASE CONFERENCE
ReGen Therapeutics Plc (‘ReGen’ or the ‘Company’) announces that the results of
an in-vivo study showing that Colostrinin(TM) increases the lifespan and
improves the neurological performance of inbred mice predisposed to premature
ageing have been accepted for presentation at the 8th International Conference
of Alzheimer’s and Parkinson’s Diseases in Salzburg Austria March 14th-18th
2007*.
Commenting on the findings, Dr. Istvan Boldogh, Principal Investigator and
Professor at the Department of Microbiology and Immunology at UTMB**, Galveston,
Texas, USA, said:
‘In this study, we investigated the effects of oral administration of
Colostrinin(TM) on the life-span and various behaviour characteristics in mice
predisposed to premature ageing. Our results showed that Colostrinin(TM) indeed
prolongs life-span and improved age-associated locomotion, motor coordination
and learning/memory capacities. Moreover, the increase in life-span and improved
neurological performance correlates well with reduced levels of oxidative stress
markers measured in various organs including the brain and liver. These results
support the view that Colostrinin(TM) has potential utility in the management of
age-related neurodegenerative diseases and improvement in the quality of life of
elderly individuals. These in-vivo results are entirely consistent with in-vitro
results that we have previously presented*** and will soon be published in the
journal of Neuropeptides’.
Commenting on the study, Percy Lomax, Executive Chairman, said, ‘ In developing
our nutraceutical product, Colostrinin(TM), we are looking to help improve
peoples’ quality of life. This study shows that with respect to ageing and
neurological functions we may be able to do that. Together with our previously
published studies on Colostrinin(TM), in particular our clinical study in
individuals with Alzheimer’s disease, we have some positive science with which
to support the anticipated launch of Colostrinin(TM) as a nutraceutical later
this year, initially through our North American licensee, Metagenics Inc.’.
A copy of the poster will be added to the ReGen website
(www.regentherapeutics.com) once it has been presented.
* 2007 Alzheimer’s and Parkinson’s Diseases: Progress and New Perspectives.
** ReGen has a sponsored research agreement with the University of Texas Medical
Branch, Galveston, Texas, USA.
***These findings were presented as a poster at the 21st International
Conference of Alzheimer’s Disease International Istanbul, Turkey 28 September to
1 October, 2005. A press release issued on 28/9/2005 and a copy of the poster is
available via the ReGen website
For further information, please contact:
Andrew Marshall
Greycoat Communications
0207 960 6007
NOTES TO EDITORS
Background:
ReGen’s principal activity is the development of a potential therapy for
Alzheimer’s disease and also the development of nutraceutical uses for
Colostrinin(TM).
Alzheimer’s disease is a progressive, neurodegenerative and ultimately fatal
disease that slowly destroys the brain. Symptoms of Alzheimer’s disease include
progressive impairment of cognitive function including memory loss, inability to
think abstractly, loss of language function, attention deficit and associated
depression, anxiety and agitation. Eventually Alzheimer’s disease sufferers lose
the ability to take care of themselves and must be looked after either by family
or in residential care homes and hospitals. Ultimately, sufferers become less
resistant to infections and other illnesses, which often become the actual cause
of death.
Clinical Data:
In a 30 week clinical study, reported in the peer reviewed Journal of
Alzheimer’s Disease in 2004, it was shown that:
• More than 40% of patients on Colostrinin(TM) were stabilised or improved after
15 weeks of therapy, based on an Analysis of Overall Response
• 33% of patients continued to show stabilisation or improvement after 30 weeks
of treatment, and levels of benefit were slightly higher at the 15-week stage
of the trial
• Efficacy demonstrated in both mild and moderate symptom groups, with greatest
effects seen in earlier stages of the disease
• No drug-related Adverse Events or safety concerns were observed during the
trial
Oxidative Stress:
Continuous low levels of oxidative damage (induced by oxidative stress) to cells
play a pivotal role in the pathogenesis of age-associated neurodegenerative
diseases such as Alzheimer’s, Parkinson’s disease and other disorders of the
central nervous system. The sources of oxidative stress manifested by the
production of reactive oxygen species (ROS) are mitochondria and are,
themselves, targets of ROS attack. Mitochondria are key organelles involved in
energy production and the generation of secondary messenger molecules, which, in
turn, regulate cells, and also control the process of apoptosis (programmed cell
death).
Metagenics Inc:
In July 2006 ReGen announced that it had entered into an exclusive licence
agreement with Metagenics, Inc. for the commercialisation of Colostrinin(TM) as
a human nutraceutical in North America.
With headquarters in San Clemente, California, Metagenics is a leading
developer, manufacturer and marketer of science-based nutraceuticals and medical
foods sold to healthcare practitioners worldwide. It is dedicated to researching
and evaluating the effects of natural ingredients on genetic expression and
protein activity. The company has manufacturing and research facilities located
in Gig Harbor, Washington, including its MetaProteomics(R) Nutrigenomics
Research Center and its Functional Medicine Research Center for human clinical
research. Metagenics holds multiple proprietary formula patents and produces
over 400 research-based products to optimise health. Metagenics demonstrates its
commitment to purity and quality through its certifications for Good
Manufacturing Practices (GMP) from the National Nutritional Foods Association,
NSF International, and the Therapeutic Goods Administration of Australia. The
company has over 30,000 healthcare practitioners promoting its products in the
North American markets alone (www.metagenics.com).
Under the terms of the licence agreement, ReGen will produce bulk Colostrinin
for delivery to Metagenics, who will carry out the final stages of production
and will arrange for marketing, distribution and sale of the final product. Both
parties are currently working closely together to establish the best
commercialisation strategy for the North American market.
The Agreement initially provides Metagenics with the exclusive right to market
Colostrinin via healthcare professionals with an option to extend exclusivity
into the retail channels, such as drugstores and supermarkets at a later date,
within six months of the products first launch. The Agreement is conditional on,
amongst other things, satisfactory completion of toxicology testing on
Colostrinin and of due diligence by Metagenics on the Colostrinin manufacturing
facilities. The toxicology programme is ongoing. Once the results are known and
the other conditions of the licence agreement have been met, the requisite U.S.
regulatory filings will be made.
Alzheimer’s and Parkinson’s Diseases: Progress and New Perspectives:
This international conference is under the auspices of the Austrian Alzheimer
Society, the Austrian Neurological Society and the Austrian Parkinson’s Society.
This meeting follows the highly successful 7th AD/PD Conference that took place
in 2005 in Sorrento, Italy and hosted nearly 1,500 participants. The abstracts
of the conference will be published as a supplement to the Neurodegenerative
Diseases Journal (NDD) published by S Karger AG and that the proceedings will be
published as a separate volume of the Neurodegenerative Diseases Journal.