Project development

The orthopedic surgery application is being developed using flexor tendon repair surgery of the hand in order to demonstrate proof of concept and to gain early regulatory approval.

The company is also investigating similar development projects targeting other surgical procedures where there is a clear medical need for more effective anti-adhesion treatments.

Preclinical Program

An extensive non-clinical program has been carried out in which the candidate drug has demonstrated significant adhesion reduction in animal models. No significant issues regarding safety pharmacology effects, local tolerance or systemic toxicity have been detected.

Clinical Program – Phase I

A successful Phase I clinical trial was completed in 2009, comprising dose escalation of single subcutaneous administration on healthy volunteers. The study established pharmacokinetic properties and did not generate any findings of concern relating to systemic safety or local tolerability.

Clinical Program – Phase II

A Phase II proof-of-concept study is currently being conducted in patients undergoing flexor tendon surgery of the hand. The study will monitor the safety and efficacy of PXL01 in reducing adhesion formation. It is being carried out at three of Sweden’s leading hand surgery clinics and will include approximately 140 patients. Results will be published in 2011.