PharmaSurgics to Extend Phase II Clinical Trial for Prevention of Post-Surgical Adhesions
Gothenburg, Stockholm, Sweden - April 12, 2010. PharmaSurgics in Sweden AB - part of the Karolinska Development dermatology and wound healing company "Pergamum" - has received approval from the Danish Medicines Agency and the Independent Ethics Committee to begin a phase II clinical trial in Denmark. The trial will monitor efficacy and safety of PharmaSurgics' novel candidate drug PXL01 for the prevention of post‐surgical adhesions in patients undergoing hand surgery.
PharmaSurgics' Managing Director, Margit Mahlapuu said "In Sweden the trial was initiated in December 2009 and the first patients have already been enrolled. Extending the study to Danish centers is an important milestone for our ongoing clinical program."
PharmaSurgics has developed an interesting and novel approach in a market with significant unmet medical needs. Success in the Phase II proof‐of‐concept study will enable the development of similar treatments for a broad range of surgical procedures.
The Phase II clinical trial will monitor the safety and document the efficacy of PXL01 in reducing adhesion formation following flexor tendon repair surgery. This indication allows for measurement of objective endpoints, rather than subjective measurements of pain. The objective of the efficacy part of the study is to see an improvement in finger mobility compared to placebo following surgery.
For further information, please contact:
Margit Mahlapuu, Managing Director, PharmaSurgics in Sweden AB
Phone: +46 (0)31 762 29 02 / Mobile: +46 (0)706 310 109
E‐mail: margit.mahlapuu@pharmasurgics.se
Jørgen Thorball, Chairman, Pergamum AB
Phone: + 45 (0)307 786 27
E‐mail: jorgen.thorball@pergamum.com
Conny Bogentoft, CEO, Karolinska Development AB
Phone: +46 (0)70 668 61 43
E‐mail: conny.bogentoft@karolinskadevelopment.com
About PharmaSurgics AB
PharmaSurgics in Sweden AB is a Gothenburg based biotech company that develops and commercializes a novel treatment for preventing harmful scarring and promoting wound healing after surgery. PharmaSurgics product concept is based on proprietary synthetic peptides which have strong anti‐inflammatory and antiinfectious properties. The company was founded in 2005, based on extensive research by Dr. Inger Mattsby Baltzer and Professor Kjell Olmarker at Sahlgrenska University Hospital, Göteborg, Sweden. PharmaSurgics is a Karolinska Development portfolio company. http://www.pharmasurgics.se/