Novel Formulation Reduces Radiation Induced Dermatitis

A liposomal formulation of human recombinant superoxide dismutase (SOD) helps control dermatitis in patients who receive radiation therapy after breast-preserving surgery.

Developed by Apeiron Biologics (Vienna, Austria) and Polymun Scientific Immunbiologische Forschung (Klosterneuburg, Austria) the novel SOD formulation, termed APN201, has demonstrated in a small phase Ib clinical trial efficacy with regard to pain, intensity of erythema, and time to occurrence of grade 2 dermatitis. However, due to the small trial size, the results are not statistically significant, and extended efficacy testing is now planned in head and neck cancer patients, which are prone to a higher incidence of more severe radiation dermatitis.

“Acute skin toxicity which may occur during high dose radiation therapy is a severe problem for many cancer patients and can in some cases even force discontinuation of the therapy,” said Karin Kapp, MD, head of the department of therapeutic radiology and oncology at the Medical University of Graz (Austria), lead investigator of the APN201 phase Ib clinical trial. “Hence, it is of utmost clinical and scientific interest to alleviate or even prevent these side effects of radiation. It is very exciting to work on a solution for this together with Apeiron.”

“We are very pleased with this first clinical experience of our liposomally formulated human SOD in cancer patients and the positive outcome of the study in Graz,” said Hans Loibner, PhD, CEO of Apeiron. “We are convinced that APN201 has the potential to become the first causal therapy for radiation-induced dermatitis and other inflammatory conditions.”

SOD is a natural human enzyme with significant antioxidative properties that catalyzes the breakdown of harmful superoxides, thereby reducing the extent of the concomitant tissue damage. Recombinant human SOD has already been tested in several clinical studies and it has shown signs of efficacy in the treatment of certain inflammatory processes.

Related Links:
Apeiron Biologics
Polymun Scientific Immunbiologische Forschung