ReGen Therapeutics was formed in February 1998 to develop Colostrinin™, a proline-rich polypeptide complex derived from mammalian colostrum. The complex and the peptides within it are viewed as having potential utility in neurodegenerative illnesses such as Alzheimer’s disease, Parkinson’s Disease, Multiple Sclerosis and Amyotrophic Lateral Sclerosis.
Colostrinin™ was originally identified by scientists working in Poland, where early clinical studies, dating back to 1995, had indicated a significant potential benefit to Alzheimer’s disease sufferers. ReGen therefore conducted a placebo-controlled clinical trial of it’s own on Alzheimer’s sufferers in Poland, which completed in mid-2002. Results from the trial showed 33% of patients achieved stabilisation or improvement in their disease condition after 30 weeks of treatment, with efficacy demonstrated in both mild and moderate symptom groups. A good safety profile and no Serious Adverse Events or other safety concerns were observed. An article reviewing the results of this trial was published in the February 2004 issue of the Journal of Alzheimer’s Disease.
The natural origin and nature of Colostrinin™ means that it conforms to the general criteria for non-pharmaceutical health supplements. Thus, since 2003 ReGen has been developing a nutraceutical version of Colostrinin™. In July 2006, the Company announced it had signed its first deal to commercialise Colostrinin™ with Metagenics Inc., a leading developer, manufacturer and marketer of nutraceuticals based in San Clemente, California. Metagenics markets Colostrinin™ as a nutraceutical under the brand name CogniSure™ in North America and Australasia, where it has been on sale, via healthcare professionals, since the last quarter of 2007.
In March 2008, the Company announced that it had signed the first European distribution agreement for Colostrinin™ with Golgi Pharmaceuticals Ltd of Cyprus. The product is approved for sale as a nutritional supplement through the professional and retail channels, which allows distribution in all health food stores and pharmacies. Cyprus is a member of the European Union which, with the US and Japan, is one of the three key target areas for Colostrinin™.
Since the beginning of 2008, additional agreements have been signed with distributors in Greece, Turkey, the Balkans, Poland and the United Kingdom. In July 2010, ReGen announced it had signed a supply agreement with USV Limited, a leading Indian company based in Mumbai, providing entry into the second most heavily populated market in the world, which has significant potential for long term profitability. Two announcements were made in December 2010; firstly, that an agreement with LG Life Sciences Ltd had been signed for exclusive distribution in South Korea and, secondly, that a Material Transfer Agreement had been concluded with Framingham Pharma, which we hope might lead to Colostrinin™ being distributed in Argentina, Uruguay and Paraguay. Discussions with potential licensing partners in other areas of the world are ongoing.
ReGen has also investigated the possibility for a nutraceutical targeted at domestic dogs and cats, and to this end conducted a study in 2007 at a UK-based veterinary practice. The results of the study showed that Colostrinin™ could significantly reduce the symptoms of cognitive dysfunction in aged cats and dogs. That Colostrinin™ was effective was reinforced by the fact that when animals were assessed one month after completion of the study, and having had no Colostrinin™ for one month, most animals showed a worsened condition.
ReGen believes that the results show a potential benefit for ageing cats and dogs and is seeking industry partners to continue the development of this project.
The Company has continued to develop the pharmaceutical potential of Colostrinin™ by carrying out pre-clinical studies at the University of Texas Medical Branch (UTMB) on the constituent peptides of the Colostrinin™ complex. Peptide activity in genes connected with the regulation of Alzheimer’s disease, obesity, hypertension and asthma has been discovered. ReGen is seeking industry partners to continue the development of this project.
As a result of its significant scientific development work ReGen has filed a substantial number of patent applications with various patent authorities throughout the World. These patents are targeted at protecting both discoveries in the field of the treatment of Alzheimer’s disease, at wider applications for Colostrinin™ and its constituent peptides.
