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Philogen granted IND approval by FDA for Phase 3 registration trial with investigational melanoma drug.

M2 PHARMA-October 12, 2017-Philogen granted IND approval by FDA for Phase 3 registration trial with investigational melanoma drug

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Privately owned Swiss-Italian biotech Philogen S.p.A. said on Thursday that the US Food and Drug Administration (FDA) has granted the company IND approval for its Phase 3 registration trial with investigational melanoma drug DAROMUN (L19IL2 + L19TNF).

The trial will see a total of 248 patients with fully resectable stage IIIB or IIIC melanoma recruited. The trial is currently underway in Italy, Germany and Poland. Results can be expected in 2020.

"The approval by FDA to expand the study in USA underscores confidence on the safety and efficacy data shown in previous studies with this product, and provides hopes to melanoma patients not adequately served by current therapies", said Philogen chief executive Duccio Neri.

The trial will centre on DAROMUN, the company's proprietary immunocytokine product. It is under development as a neoadjuvant therapy, which will be administered via intratumoral injections in stage IIIB/C melanoma patients.

"DAROMUN combines a number of desirable characteristics such as good tolerability and efficacy that make it an exciting and promising immunotherapy for the treatment of resectable melanoma," commented Professor Dr Dario Neri, co-founder and president of the Scientific Advisory Board of Philogen.

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Publication:M2 Pharma
Date:Oct 12, 2017
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