Published on September 11, 2012 at 4:13 AM
Pergamum AB announced today that dosing has begun in a randomized Phase
I/II trial of LL-37 for the treatment of patients with hard-to-heal
venous leg ulcers. Karolinska Development AB (STO: KDEV) is the majority
owner of Pergamum.
"Non-healing wounds are a huge burden for the individual patient and for
the health care system. Today, there are an estimated 15 million
patients globally, and virtually no medical progress has been made over
the last few decades", said Jonas Ekblom, CEO of Pergamum AB. "This
clinical trial will allow us to evaluate a promising new treatment,
based on the body's own immune defense, for patients with venous leg
ulcers. The ultimate goal is to accomplish faster healing and improved
quality of life for patients who typically have a poor prognosis."
In this double blind multicenter study, patients with chronic leg ulcers
will be randomized to receive either placebo or one of three different
doses of LL-37. The primary objective of the trial is to assess the
safety and tolerability of Pergamum's proprietary formulation of the
therapeutic peptide LL-37. The Phase I/II study is expected to enroll 32
patients. The principal investigator is Dr. Ola Rollman, associate
professor at the Department of Medicine at Uppsala University, Sweden.
"This is the third drug candidate developed by Pergamum that enters
clinical development. It is primarily a safety study but we will also be
able to see early signs of efficacy", said Torbjörn Bjerke, CEO of
Karolinska Development AB and Chairman of the Board of Pergamum." The
progressing of LL-37 into human trials is yet another sign of our
ability to mature our project portfolio."