Released: Thursday 15th May 2014

RNS & Investor News

15 May 2014

Excellagen®enters new clinical trial

Collagen Solutions plc (AIM: COS), the developer and manufacturer of medical grade collagen components for use in regenerative medicine, medical devices and in-vitro diagnostics, announces that Excellagen®, a product based on Collagen Solutions' medical grade bovine collagen, has been selected as part of a clinical evaluation in a Phase 1b safety study for the potential treatment of chronic diabetic wounds to be funded via project "REDDSTAR" which has received more than Euro 5 million from the European Union under EU Framework 7 (FP7).

Excellagen® flowable dermal matrix, manufactured by Taxus Cardium Pharmaceuticals Group Inc ("Cardium"), is a pharmaceutically formulated fibrillar Type I bovine collagen gel for wound care management which is based on the medical grade collagen supplied by Collagen Solutions and has been cleared by the FDA for the treatment of chronic non-healing dermal wounds. In this trial, Excellagen® is being used in combination with the mesenchymal stromal stem cell therapy Cyndacel-M™ manufactured by Orbsen Therapeutics. This means that the Company's medical grade collagen is now embedded in Cardium's value chain. This clinical evaluation Phase 1b safety study is being coordinated at Ireland's Regenerative Medicine Institute at the National University of Ireland Galway (NUI).

50 million diabetic EU citizens are using approved anti-diabetic agents to control their glycaemia. However, suboptimal glycaemic control leads to progressive diabetic complications, namely: nephropathy, retinopathy, cardiomyopathy, neuropathy and foot ulceration. In 2010, 11% of EU adult deaths (634,000) were caused by diabetic complications. Investigation of this combination therapy could be instrumental in reducing those unnecessary deaths considerably.

Commenting on this announcement, Dr Stewart White, CEO of Collagen Solutions said: "We are supplying medical grade collagen products to an increasing number of regenerative medicine and medical device companies.  In many cases it has been shown that these collagen constructs have utility beyond their initial registration for use. Excellagen® is a prime example of this where our partnership with Cardium has helped create the product and, following registration, Cardium have been able to explore additional uses for the product which exemplifies the value provided by Collagen Solutions to such products."