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 though further clinical results will confirm just how beneficial Colostrinin™ will be in the future as a reliable treatment.

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. For further information about the availability of Colostrinin™ call 02 47349010 (Australia) or contact us via our contact us page.