Alzheimer's disease is a progressive, neurodegenerative and ultimately fatal disease that slowly destroy 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, they become less resistant to infections and other illnesses, which are often the actual cause of death.
Alzheimer's disease is the most common form of dementia and currently affects over 13 million people worldwide. The direct and indirect cost of Alzheimer care is over $100 billion (€ 81 billion) in the US alone. The direct cost of Alzheimer care in the UK is estimated at £15 billion (€ 22 billion).
Due to the failure of drugs having any significant impact on the condition, research into the treatment for Alzheimer's has been redirected to discovering possible treatments using colostrum extracts. ReGen Therapeutics has played a major role in this development and now is in the position after many years of research to release a product onto the market place which has been trademarked under the name of Colostrinin™. It has been under development as a nutraceutical treatment for 'the prevention of cognitive decline' in both humans and animals. In particular, diseases such as such as Alzheimer's and possibly the treatment of Parkinson's Disease.
From a general terminology point of view, Colostrinin™ is a proline-rich polypeptide complex produced from colostrum (a mammal's first milk) and is being developed as a nutraceutical for use in humans and animals for the prevention of early stage cognitive decline and is in advanced development as a treatment for Alzheimer's disease. Current research has been promising with Colostrinin™ showing efficacy in a 106 patient, placebo controlled trial conducted in mild/moderate Alzheimer's sufferers over 30 weeks. Results announced in April 2005 indicate that peptides within Colostrinin may have potential as a therapy for Parkinson's disease as well.
Colostrinin™ is ReGen's lead compound, which as mentioned is a proline-rich polypeptide complex produced from colostrum (a mammals' first milk after birth). In in vitro studies Colostrinin™ has been shown to prevent the aggregation of beta-amyloid and reduce it’s toxicity to cells. Beta-amyloid is the toxic peptide that is the main constituent of the characteristic plaques’ that form in the brains of people with Alzheimer’s disease and cause loss of cognitive function. Colostrinin™ has also been shown to protect cells from oxidative stress another of the pathologies implicated in Alzheimer’s disease. In in vivo studies Colostrinin™ has been shown to improve memory performance of aged rats in the Morris water maze test. Colostrinin has shown efficacy in a 106 patient, placebo controlled trial conducted in mild/moderate Alzheimer's sufferers over 30 weeks. Furthermore, Colostrinin™ and a synthetic homologue of Colostrinin™-derived peptide show neuroprotection in a cell line model of Parkinson's disease. An in vitro study has shown that pre-treatment with Colostrinin™ and a synthetic version of a peptide shown to occur naturally in Colostrinin™ can protect cells of the kind that are depleted in Parkinson's disease from damage by a chemical known to be selectively toxic to them. The initial data from this study suggests that Colostrinin™ and peptides within it may protect dopaminergic neurones against degeneration.
An in vitro study has shown that Colostrinin™ can cause precursor nerve cells to differentiate and proliferate. These findings suggest that Colostrinin™ treatment may control the expression of genes that are involved in the development, maintenance, and regeneration of neurons in the central nervous system, and thus may also explain the improvements observed in Alzheimer's patients with mild-to-moderate dementia during treatment with Colostrinin™.
A further in vitro study has shown that Colostrinin™ increases the lifespan of cells isolated from inbred mice predisposed to premature ageing and therefore, death. This study shows the impact of Colostrinin™ on the mitochondria of cells isolated from strains of senescence-prone (SAMP1) and senescence-resistant (SAMR1) mice. The data show that cells from SAMP1 mice produce more ROS, exhibit severe mitochondrial dysfunction, and have a decreased lifespan compared to the cells from SAMR1 mice. Addition of Colostrinin™ to SAMP1 cells significantly decreased ROS levels, normalized mitochondrial function and increased the lifespan to levels similar to those in SAMR1 cells. This is an exciting finding that may go toward explaining the cognitive benefits of Colostrinin™ seen in clinical studies. In vivo experiments are now ongoing to test if these effects are evident when SAMP1 and SAMR1 mice are given Colostrinin™ over their lifetime.
Having now achieved the production of Colostrinin™ at industrial scale ReGen announces that it is starting formal safety studies with Colostrinin™. While there have been no safety concerns associated with the use of Colostrinin™ in previously conducted safety or clinical studies, this is a key milestone for ReGen as these earlier studies used Colostrinin™ made with a small-scale process and using ovine rather than bovine colostrum. In parallel with the safety program, work continues to complete the incorporation of Good Manufacturing Practise (GMP) into the production process.
Last September ReGen presented preliminary evidence of an anti-ageing effect from Colostrinin™ at the 21st International Conference of Alzheimers Disease International taking place in Istanbul. Researchers saw that the product increased the lifespan of cells isolated from mice predisposed to premature ageing and therefore, death, when they tested its impact on the mitochondria of cells isolated from strains of senescence-prone (SAMP1) and senescence-resistant (SAMR1) mice.
While cells from SAMP1 mice produce more reactive oxygen species (ROS), exhibit severe mitochondrial dysfunction, and have a decreased lifespan compared to the cells from SAMR1 mice, adding Colostrinin™ significantly decreased ROS levels, normalized mitochondrial function and increased the lifespan to levels similar to those in SAMR1 cells.
Continuous low levels of oxidative damage to cells, caused by ROS, play a key role in age-associated neurodegenerative diseases such as Alzheimer's, Parkinson's disease and other disorders of the central nervous system.
Conclusion:
Based on current research, Colostrinin™ has the potential as a treatment for Alzheimer’s disease, Parkinson's disease and other neurodegenerative disease conditions.
Future Market & Availability:
ReGen Therapeutics is poised for the first launch of its Colostrinin™ nutraceutical for early stage cognitive decline, with the signing of a licensing agreement in North America & Australia.
A spokesperson for the company confirmed that an introduction through Metagenics make Colostrinin™ available for the first time, anywhere in the world. ReGen is hoping that it will come to market in late 2007, but it is dependent on completion of toxicology testing, regulatory filings and due diligence on bulk manufacturing facilities in South Dakota.
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http://www.quantumevolution.com.au/colostrinin.htm
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