09/05/2006
ReGen Starts Safety Studies with Industrial Scale Bovine ColostrininTM to Support its Commercialisation as a Nutraceutical
Having now achieved the production of ColostrininTM at industrial scale ReGen Therapeutics Plc (‘ReGen’), announces that it is starting formal safety studies* with ColostrininTM its proline-rich polypeptide extract of bovine colostrum**. While there have been no safety concerns associated with the use of ColostrininTM in previously conducted safety or clinical studies, this is a key milestone for ReGen as these earlier studies used ColostrininTM made with a small-scale process and using ovine rather than bovine colostrum. In parallel with the safety programme, work continues to complete the incorporation of Good Manufacturing Practise (GMP) into the production process.
Commenting, Mr. Percy Lomax ReGen’s Chairman and Chief Executive said, ‘Being able to demonstrate that the version of ColostrininTM that we are proposing to sell commercially as a nutraceutical is as safe and effective as that used in our previous experimental and clinical studies is crucial to clinching a deal with a marketing partner. We have recently shown that our bovine new process material has the same physical characteristics and potency as the original ovine material. With the imminent start of definitive safety studies and their completion in due course, the conclusion of a commercial deal and the eventual marketing of ColostrininTM moves a great deal closer’.
ReGen are currently discussing the commercial licensing of ColostrininTM for use as a human nutraceutical with separate partners in North America, Japan and other regions of the World.
For further information, please contact:
Andrew Marshall
Greycoat Communications
Tel No 020 7960 6007
* These studies are being conducted for ReGen by a well known contract research organisation based in the USA.
** ColostrininTM is being manufactured for ReGen by Sterling Technology Inc. an experienced processor of colostrum products based in Brookings, South Dakota, USA.