Apeiron have announced that the clinical trial with APN201 (a liposomal formulation of human recombinant superoxide dismutase) has been completed and achieved all endpoints. The study was conducted at the Department of Therapeutic Radiology and Oncology of the Medical University Graz in a double blind, placebo-controlled fashion with 20 female breast cancer patients who received radiation therapy after breast-preserving surgery.
Superoxide dismutase (SOD) is nature´s most potent antioxidant enzyme and renders harmless highly reactive oxygen radicals that are generated during radiation therapy, hence exerting a strongly anti-inflammatory effect. In general, about every other cancer patient receives radiation therapy in addition to chemotherapy and surgery. Often, concomitant acute skin damage occurs which is comparable to burns. The latter can be severe and even lead to discontinuation of radiation therapy. Today, this collateral damage of radiation therapy is only treated symptomatically with skin cremes.
In this pilot (phase Ib) study, APN201 was applied daily and shown to be safe and well tolerated with no drug related adverse events reported. Furthermore APN201 showed first signs towards efficacy with regard to pain, intensity of erythema (reddening of the skin) and time to occurrence of grade 2 dermatitis. Due to the small trial size, these results are not statistically significant. Thus, extended efficacy testing is now planned in head and neck cancer (HNC) patients, which are prone to a higher incidence of more severe radiation dermatitis.
APN201 is being developed clinically in collaboration with the Austrian CMO Polymun Scientific.
Hans Loibner, PhD, CEO of 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. We are convinced that APN201 has the potential to become the first causal therapy for radiation-induced dermatitis and other inflammatory conditions."
University Professor Karin S. Kapp, MD, Head and Chair of the Department of Therapeutic Radiology and Oncology, Medical University of Graz and principal investigator of the study, commented: "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. 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."