Sweden clears Ph I for PharmaSurgics' scar-formation product

Gotenburg, Sweden-based PharmaSurgics AB has received approval from the domestic medical product agency to proceed to Phase I clinical  documentation with the novel candidate drug, PXL01, indicated for  post-surgical adhesion prevention. The clinical program will be  initiated in March.

Adhesions are bands of scar tissue that connect anatomic structures that  should not normally be connected. These develop when the body's repair  mechanisms respond to tissue injury as the result of surgical trauma.  Adhesions form after almost any type of surgery and are a significant  source of post-surgical complications for millions of patients, a major  burden for surgeons and a great economic load on the health care  systems.

Currently, the problem does not have any satisfying solution and there  is a great need for new products. PXL01, PharmaSurgics patented drug  candidate, has demonstrated an excellent effect and safety profile in  preclinical studies and the first clinical trial on patients is planned  to start in the end of 2009, the firm said. The biotechnology company's  goal is to be first to market with a pharmacological product for the  prevention of post-surgical adhesions.