STOCKHOLM – June 27, 2013. Pergamum AB announced today that several end-points were met in a randomized Phase II trial of PXL-01 for prevention of post-surgical adhesions. Karolinska Development AB is the majority owner of Pergamum.
Many patients undergoing hand surgery suffer from debilitating scar formation, which reduces the range of motion and complicates daily activities. PXL-01 is a novel therapeutic peptide that has been developed with the purpose to reduce the formation of obstructing scars and restore mobility and function.
Follow-up data from the Phase II clinical trial of PXL-01 at 6 and 12 months post-surgery revealed a statistically significant improvement in functional hand recovery compared to placebo. Treatment was not associated with any safety issues or increase in the rate of tendon rupture. In total, 138 patients undergoing hand surgery were treated in this prospective, double-blind, randomized, placebo controlled clinical trial conducted in Sweden, Denmark and Germany. Top-line data from this study was first reported in July 2012.
“Post-surgical adhesions represent a large medical need. Pergamum’s investigational drug shows a promising and clinically relevant effect on endpoints that are important indicators of deficit in hand function after surgery”, said Associate Professor Marianne Arner, Head of the Department of Hand Surgery, Södersjukhuset, Stockholm.
“These compelling results give us the confidence to proceed with the development of the product to the orthopedic surgery segment and other indications, where adhesions and scars represent a considerable debilitating adverse effect. According to in-house estimates, the global market for surgical sealants, wound adhesives and anti-adhesives is in the excess of USD 10bn”, said Jonas Ekblom, CEO of Pergamum.
“The 6 and 12-month follow-up data from this clinical trial show a clear benefit for the patients treated with PXL-01. We strongly feel that PXL-01 has the potential of becoming the first pharmaceutical product registered to target post-surgical adhesions”, said Torbjörn Bjerke, CEO of Karolinska Development AB and Chairman of Pergamum AB.
For further information, please contact:
Jonas Ekblom, President and CEO, Pergamum AB
Phone: +46 (0)8 470 37 40, e-mail: jonas.ekblom@pergamum.com
Torbjörn Bjerke, CEO, Karolinska Development AB Phone: +46 (0)72 744 41 23, e-mail: torbjorn.bjerke@karolinskadevelopment.com
Benjamin Nordin, IRO, Karolinska Development AB Phone: +46 (0)73 093 60 80, e-mail: benjamin.nordin@karolinskadevelopment.com
About Pergamum
Pergamum is a biopharmaceutical company specialized in the development of therapeutic peptides for local application in infections and wounds. The company’s vision is to develop a portfolio of unique development programs representing high medical value that ultimately, through global partnerships, will result in first-in-class and first-in-category products. The current development pipeline includes several therapeutic peptides of which three programs are in clinical development, with potential for use in several medical applications. Please visit our web site: www.pergamum.com.
About Karolinska Development
AB Karolinska Development aims to create value for investors, patients, and researchers by developing innovations from world class science into products that can be sold or out-licensed with high returns. The business model is to: SELECT the most commercially attractive medical innovations; DEVELOP innovations to the stage where the greatest return on investment can be achieved; and COMMERCIALIZE the innovations through the sale of companies or out-licensing of products. An exclusive deal flow agreement with Karolinska Institutet Innovations AB, along with other cooperation agreements with leading Nordic universities, delivers a continuous flow of innovations. Today, the portfolio consists of 38 projects, of which 16 are in clinical development. For more information, please visit www.karolinskadevelopment.com.
Karolinska Development is listed on NASDAQ OMX. Karolinska Development may be required to disclose the information provided herein pursuant to the Securities Markets Act.