NGR-hTNF is a first-in-class compound based on the combination of a tumour homing peptide (NGR) with the human Tumour Necrosis Factor (hTNF). The resulting molecule has unique activity, including a direct biological antitumour activity and an increase of vascular permeability, thus making NGR-hTNF particularly attractive both as novel single agent therapeutic option, and as a part of a combination therapy with most chemotherapy regimens.
Ongoing trials as single agent include: Phase III trial in mesothelioma, Phase II trials in colorectal cancer and liver cancer; a Phase I trial exploring the administration of NGR-hTNF at high doses.
Ongoing combination trials include: a Phase II trial with Xelox in colorectal cancer, two Phase II trials with doxorubicin in small-cell lung cancer (after treatment of a first sample size in the single agent setting) and in ovarian carcinoma, and a Phase II trial with platinum-based regimens in non-small-cell lung cancer; a Phase I trial in combination with cisplatin.
NGR-hTNF was granted Orphan Drug designation in the European Union and in the United States:
- in 2008 for the treatment of mesothelioma (EU/3/08/549)
- in 2009 for the treatment of liver cancer (EU/3/09/686)
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