Additional information required before initiation of Tripeps' ChronSeal phase II study Prior to initiating Tripeps' ChronSeal phase II study, the Medical Products Agency (MPA) demands additional information regarding the Japanese production facility and a revision of the study protocol. These measures are expected to be concluded during the first half of April. Under condition that these measures are deemed for an approval, a new application is expected to be filed during April. If further study documentation is required, a new application is expected to be filed during 2008. “Previously, two clinical pilot studies have been concluded where patients who received active treatment had a 60 percent healing after one week treatment. Earlier this year we also successfully concluded a safety study on animals of the antibiotic free-formulation of ChronSeal. This - in combination with our assessment that we in short time will be able to comply with the MPA demands - makes us keep high expectations on the product and, as previously stated, that we should be able to initiate the study under 2008”, says Jan Nilsson, CEO Tripep AB. 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 TO THE EDITORS 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. About ChronSeal ChronSeal is a HGF-based (Hepatocyte Growth Factor) treatment for chronic leg wounds, a rapidly increasing problem among the elderly population of the Western World. In cooperation with Tripep's partners Kringle Pharma and Zelmic AB, a new formulation has been developed that enables the use of ChronSeal without it being combined with antibiotics. The new formulation allows for controllable release of HGF, while avoiding 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. More than four million people in the US and Europe are currently suffering from chronic leg wounds. This corresponds to a market value of approximately SEK12 billion. Accordingly, the medical need is considerable and the growth rate is high, factors that are expected to provide ChronSeal with substantial commercial potential.
Additional information required before initiation of Tripeps' ChronSeal phase II study
| Source: Fastilium Property Group AB