Policy & Regulation
Philogen to begin clinical trial of Nidlegy in nonmelanoma skin cancer patients following approval from Swiss national competent authority
29 June 2020 -

Swiss biotechnology company Philogen SpA reported on Friday the receipt of approval from the Swiss national competent authority Swissmedic to start a clinical phase II study in patients with locally advanced, not metastatic nonmelanoma skin cancer.

A favorable opinion about the study has reportedly been awarded by EKOS (Ethics Committee of Eastern Switzerland).

Under the clinical study, the patients enrolled will be treated with intralesional injections of Nidlegy, which is the combination of the two active principles bifikafusp alfa (L19IL2) and onfekafusp alfa (L19TNF). The combination has already shown promising results in the intralesional neoadjuvant treatment of patients with resectable Stage III melanoma in two phase III clinical trials.

The company stated the durable responses, the excellent safety profile and the favorable 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.

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