PhilogenS.p.A., a privately-owned biotechnology company, announce that the Swiss national competent authority Swissmedic issued the authorization to run a clinical phase II study in patients with locally advanced, not metastatic nonmelanoma skin cancer. A favourable opinion about the study has now also been obtained by EKOS (Ethics Committee of Eastern Switzerland).
Nidlegy, the combination of the two active principles bifikafuspalfa (L19IL2) and onfekafuspalfa (L19TNF), has already shown promising results in the intralesional neoadjuvant treatment of patients with resectable Stage III melanoma in two phase III clinical trials.
Patients enrolled in the clinical study will be treated with intralesional injections of Nidlegy. The durable responses, the excellent safety profile and the favourable cosmetic outcome of injected melanoma lesions have reinforced the investigation of efficacy and safety of Nidlegy in injectable, locally advanced and not metastatic lesions of basal cell carcinoma or cutaneous squamous cell carcinoma.
"We are delighted to start the clinical phase II study in Switzerland and to explore the potential of Nidlegy in patients with locally advanced, not metastatic nonmelanoma skin cancer," commented Prof. Dario Neri, co-founder and president of the Scientific Advisory Board of Philogen.