NGR-hTNF (antitumor recombinant protein)

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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]

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References

  1. "NGR hTNF among the Top 10". http://www.biotechnology-europe.com.{{cite web}}: External link in |publisher= (help)
  2. Lorusso D, Scambia G, Amadio G, di Legge A, Pietragalla A, De Vincenzo R, Masciullo V, Di Stefano M, Mangili G, Citterio G, Mantori M, Lambiase A, Bordignon C (Jun 2012). "Phase II study of NGR-hTNF in combination with doxorubicin in relapsed ovarian cancer patients". British Journal of Cancer. 107 (1): 37–42. doi:10.1038/bjc.2012.233. PMC   3389423 . PMID   22644293.
  3. "MolMed a New Patent on Its Anticancer Drug NGR-hTNF". http://finance.yahoo.com.{{cite web}}: External link in |publisher= (help)
  4. "MolMed PhaseIII Trial on NGRhTNF". http://www.biotechnology-europe.com.{{cite web}}: External link in |publisher= (help)
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  10. 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 (7): 107(1):37–42 1, 17 (7): 1964–72, doi: 10.1158/1078-0432.CCR-10-1376 , PMID   21307147
  11. "MolMed new data ngr htnf". https://www.drugs.com.{{cite web}}: External link in |publisher= (help)
  12. "Safety and anticancer activity of low dose regimen of NGR-hTNF" (PDF). www.molmed.com.
  13. 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
  14. Curnis, Flavio; Sacchi, Angelina; Corti, Angelo (2002). "Improving chemotherapeutic drug penetration in tumors by vascular targeting and barrier alteration". Journal of Clinical Investigation. 110 (4): 475–482. doi:10.1172/jci0215223. PMC   150417 . PMID   12189241.
  15. 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
  16. 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 . PMID   21307147.
  17. "MolMed Completes Enrolment in Pivotal Phase III". http://www.evaluategroup.com/.{{cite web}}: External link in |publisher= (help)
  18. "MolMed starts Phase III trial of NGR-hTNF in mesothelioma" (PDF). www.molmed.com/.
  19. "US FDA Grants Orphan Status to Mesothelioma Drug". www.asbestos.net/.
  20. "MolMed Expands Phase III Trial of NGR-hTNF for the Treatment of Mesothelioma in the United States". finance.yahoo.com/.