Tripeps phase II study of ChronSeal® approved by the Swedish Medical Products Agency
Tripep has initiated a phase II study of ChronSeal®, the product co-owned by Tripep and Kringle Pharma, for the treatment of chronic leg wounds. The study - already approved by the Norwegian Medical Agency - is a placebo controlled multicenter study which now after the approval of the Swedish MPA will be carried out in Sweden and Norway. It will enrol 75 patients and is estimated to be completed towards the end of 2009.
ChronSeal® is a cream based on HGF (Hepatocyte Growth Factor) for the treatment of chronic leg wounds, a problem which is rapidly growing in the ageing population of the Western world. Together with its partners Tripep has developed a new formulation which results in a controlled release of HGF and in addition it enables the use of ChronSeal® without having to combine it with antibiotics. This, in turn, avoids development of antibiotic resistance, another rapidly growing problem. An application for a patent pertaining to an antibiotic-free formulation of ChronSeal® was filed in the US in January 2008.
”We have previously seen very good results in a pilot study in which 8 out of 11 patients experienced a reduction of wound area of 60 to 100% following one week of active treatment. Based on these most encouraging result it is with great expectations we look forward to the initiation of the phase II study with the new antibiotic-free formulation of ChronSeal®”, says Jan Nilsson, CEO of Tripep.
More than four million people in the US and Europe are currently suffering from chronic leg wounds which corresponds to a market value of approximately SEK 36 billion. Accordingly, the medical need is considerable and the growth rate is high, factors that are expected to provide ChronSeal® with substantial commercial potential.
For more information, please contact:
Jan Nilsson, CEO, Tripep AB
Tel: +46 8 449 84 80
Mobile phone: +46 70 466 31 63
E-mail: jan.nilsson@tripep.se
Anders Vahlne, Head of Research, Tripep AB
Tel: +46 8 5858 1313
Mobile phone: +46 709 28 05 28
E-mail: anders.vahlne@ki.se
About Tripep
Tripep develops drugs against chronic disease based on proprietary and other parties’ patented and patent pending technologies. Tripep is focusing on the following research projects; wound healing therapy ChronSeal® and a therapeutic vaccine against Hepatitis C, named ChronVac-C®, plus the RAS® technology platform. The Tripep share is admitted to trade on First North. Remium AB is Certified Adviser for Tripep AB. For more information, please refer to the company’s website: www.tripep.se.
In the event of any discrepancy between the Swedish and English versions of this press release, the Swedish version will take precedence