ChronSeal
ChronSeal is a gel containing human hepatopoietin (Hepatocyte Growth Factor, HGF), which plays a key role in wound-healing. This is a new biological therapy method that creates new opportunities for slow-healing ulcers, particularly venous leg ulcers and diabetic ulcers. The treatment method has been successfully tested on patients with chronic leg ulcers. It is based on the discovery that normal HGF is defective in many slow-healing ulcers, and is thus not active in the patient. By providing the patient with active HGF in combination with suitable antibiotics, it is possible to restore the cellular balance and promote the wound-healing process. HGF can be industrially produced from plasma, but also synthetically. Combination therapy with antibiotics is necessary, because wound bacteria can metabolise HGF.
Development and Future Trials
Until the present, two clinical pilot studies have been successfully conducted on a total of 24 patients with chronic leg ulcers. Eight of the eleven patients that received functional HGF attained 60% wound healing and improved blood circulation after just a week's treatment. It was also possible to demonstrate that treatment efficacy of defective HGF was comparable with placebo. The pilot studies were approved by an ethical committee at Linköping University Hospital.
The agreement with Kringle Pharma ensures Tripep access to HGF for the forthcoming phase II trial. In this trial, patients with chronic leg ulcers will be treated by a combination of ChronSeal and appropriate antibiotics. After the trial, the subjects will be monitored to study the risk of recurrence after healing. The objective is to heal the wound in most patients and then ensure healing sustains. In parallel with ChronSeal's clinical development, Tripep is also planning to conduct an economic study in collaboration with internationally renowned treatment centres.
Tripep's ambition is to develop ChronSeal alongside a global wound care player in the chronic skin wound segment after the planned phase II trial has been conducted.