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NGR-hTNF is an experimental antitumor drug designed to act on tumor blood vessels.[1][2][3] It is currently undergoing Phase III clinical trials[4] for treatment of malignant pleural mesothelioma caused by exposure to asbestos.[5][6][7] NGR-hTNF is also being investigated, alone or in combination with chemotherapy,[8] on four different solid tumors[9][10] in four other randomized Phase II trials.[11]
NGR-hTNF is a recombinant protein derived from the fusion between peptide CNGRCG [12] and human tumor necrosis factor alpha[13] (TNFα).[14][15]
Once it has reached the tumor, NGR-hTNF performs its antitumor action.[16]
The Phase III (NGR015) [17] clinical trial is in progress in 35 clinical centers in Europe (Italy, UK, Ireland, Poland and Belgium), USA, Canada and Egypt. NGR-hTNF is the only drug being tested in Phase III trials [18] for the treatment of relapsed Mesothelioma, and has been granted Orphan Drug designation both in Europe and USA.
[19][20]
^Lorusso D, Scambia G, Amadio G, Di Legge A, Pietragalla A, De Vincenzo R, masciullo V, Di Stefano M, Mangilli G, Citterio G, Mantori M, Lambiase A, Bordignon C (2012-06-26), Phase II study of NGR-hTNF in combination with doxorubicina in relapsed ovarian cancer patients. Br J Cancer, pp. 107(1):37–42
^Gregorc V, De Braud FG, De Pas TM, scalamogna R, Citterio G, Milani A, Boselli S, Catania C, Donadoni G, Rossoni G, Ghio D, Spitaleri G, Ammannati C, Colombi S, Caligaris-Capio F, Lambiase A, Bordignon C (Apr 2011), "Phase I study of NGR-hTNF,a selective vascular targeting agent, in combination with cisplatin in refractary solid tumors. Clin Cancer Res", Clin. Cancer Res., 17: 107(1):37–42 1, 17 (7): 1964–72, doi:10.1158/1078-0432.CCR-10-1376, PMID21307147
^Curnis F, Sacchi A, Borgna L, Magni F, Gasparri A, Corti A (2000), Enhancement of tumor necrosis factor alpha antitumor immunotherapeutic properties by targeted delivery to aminopeptidase N (CD13). Nat Biotechnol, pp. 18:1185–1190.
^Fiers. Biologic therapy with TNF: preclinical studies. In: Company JL, ed. Biologic therapy of cancer: principles and practice, Philadelphia: (ed V De Vita, S Hellman and S Rosenberg (edts))., pp. 1995:295
^Gregorc V, De Braud FG, De Pas TM, Scalamogna R, Citterio G, Milani A, Boselli S, Catania C, Donadoni G, Rossoni G, Ghio D, Spitaleri G, Ammannati C, Colombi S, Caligaris-Cappio F, Lambiase A, Bordignon C (Apr 2011). "Phase I study of NGR-hTNF, a selective vascular targeting agent, in combination with cisplatin in refractory solid tumors". Clinical Cancer Research. 17 (7): 1964–72. doi:10.1158/1078-0432.CCR-10-1376. PMID21307147.
