Date: 2013-06-27
Type of information:
phase: 2
Announcement: results
Company: Pergamum (Sweden)
Product: PXL-01
Action mechanism: 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.
Disease: prevention of post-surgical adhesions
Therapeutic area:
Country: Sweden, Denmark and Germany
Trial details: In total, 138 patients undergoing hand surgery have been included in Pergamum’s placebo controlled, multi-center trial that has been conducted in Sweden, Denmark and Germany. The trial evaluates the safety and effectiveness of the novel therapeutic peptide PXL01 to improve mobility and function of the hand after surgery. Many patients undergoing hand surgery today suffer from debilitating scar formation which reduces the range of motion and complicates daily activities. PXL01 is a product under development with the purpose to reduce the formation of obstructing scars and restore mobility and function back to the patient’s normal level. The final patient will be followed-up for a period of 12 weeks.
Latest
news: * On June 27, 2013, Pergamum AB has announced that several end-points were met in a randomized Phase II trial of PXL-01 for prevention of post-surgical adhesions. 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 (See below).* On July 10, 2012, Pergamum AB, a Karolinska Development portfolio company, has announced top-line results from the randomized first time in patient Phase II trial of PXL-01 for prevention of post-surgical adhesions. The study showed that the drug was safe and well tolerated. The primary end point of the study was not met. Top-line results from the Phase II trial on subjects that have undergone tendon repair surgery in the hand have now been analyzed. Treatment with PXL-01 was well tolerated, and did not adversely affect tendon or wound healing. The study did not show any statistically significant difference between the group that were treated with PXL-01 and the placebo group measured as TAM2 (Total Active Motion, sum of two finger joints), which was the primary end point. However, there is a clear trend that treatment with PXL-01 may improve the postoperative outcome as the number of patients categorized as having good or excellent mobility of the injured finger 12 weeks after the surgery, was higher compared to treatment with placebo. In the group treated with PXL-01, 67 percent of the subjects demonstrated excellent or good range of motion according to Strickland’s classification scale, compared to 48 percent of the subjects in the group treated with placebo. This endpoint is an important indicator of deficit in hand function after the surgical procedure.
In total, 138 patients undergoing hand surgery was treated in this prospective, double-blind, randomized placebo controlled clinical trial conducted in Sweden, Denmark and Germany. The final Phase II report is expected to be published in the third quarter 2012 while the trial continues to include 6 and 12 months follow up. The company is now lookinf forward to concluding the study in February 2013 including follow up data.
