Tripep and Kringle Pharma applies cooperatively for permission to launch a Phase II study of ChronSeal
Tripep has submitted an application to the Medical Products Agency concerning the initiation of a Phase II study of ChronSeal, a product owned jointly by Tripep and Kringle Pharma for the treatment of chronic leg wounds. The study, which will take the form of a placebo controlled multicenter study, will be implemented in Sweden and comprise 60 patients. If approval is granted, it is estimated that the study will start during the first half of 2008.
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 earlier this month.
"Two clinical pilot studies comprising a total of 24 patients have been conducted, which showed that those patients who received active treatment attained 60% wound healing after one week. Thanks to these excellent treatment results, we have great expectations concerning the imminent Phase II study based on the new, antibiotic-free formulation," says Jan Nilsson, CEO of Tripep.
"Kringle and Tripep have been working closely together for a year and this is a significant milestone for both companies," says Kunio Iwatani, CEO of Kringle Pharma. "We maintain and strengthen good relations with each other to meet the requirements necessary to bring this HGF-based novel therapy to the market."
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.
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 AB
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 Kringle Pharma, Inc.
Kringle Pharma is a biopharmaceutical company established in 2001 to develop novel biologics based on HGF and NK4, both discovered by Professor Toshikazu Nakamura at Osaka University. Currently, Kringle’s pipeline consists of human recombinant HGF for the treatment of 1) acute renal failure, 2) skin ulcers, and 3) CNS diseases, in addition to human recombinant NK4 and NK4 gene drug for cancer therapies. For more information, please refer to the company’s website: www.kringle-pharma.com/en/index.html .