Colostrinin

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, where it has been on sale, via healthcare professionals, since the last quarter of 2007. Distribution deals have been signed in several countries and ReGen continues to look for distributors in others worldwide.

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.