Development and licensure of medical countermeasures to treat lung damage resulting from a radiological or nuclear incident

Radiation Research

Volumn 177, Issue 5, 2012, Pages 717-721

  Dicarlo, Andrea L ^a   Jackson, Isabel L ^b   Shah, Jui R ^a   Czarniecki, Christine W ^a   Maidment, Bert W ^a   Williams, Jacqueline P ^c  

^a NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES   (United States)

^b DUKE UNIVERSITY MEDICAL CENTER   (United States)

^c UNIVERSITY OF ROCHESTER MEDICAL CENTER   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

DEXAMETHASONE;

ACUTE RADIATION SYNDROME; ARTICLE; HUMAN; LUNG FIBROSIS; LUNG INJURY; PNEUMONIA; PRIORITY JOURNAL; RADIATION DOSE; RADIATION EXPOSURE; RADIATION INJURY; RADIATION SAFETY; WHOLE BODY RADIATION;

ACUTE RADIATION SYNDROME; ANIMAL EXPERIMENTATION; ANIMALS; BIOLOGICAL MARKERS; HUMANS; LICENSURE; LUNG; LUNG DISEASES; MODELS, ANIMAL; NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (U.S.); NUCLEAR WARFARE; PULMONARY FIBROSIS; RADIATION INJURIES, EXPERIMENTAL; RADIATION PNEUMONITIS; RADIATION TOLERANCE; RADIATION-PROTECTIVE AGENTS; RADIOACTIVE FALLOUT; RADIOACTIVE HAZARD RELEASE; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

ANIMALIA;

EID: 84861408928     PISSN: 00337587     EISSN: 19385404     Source Type: Journal    
DOI: 10.1667/RR2881.1     Document Type: Article

References (32)

1. Pellmar TC, Rockwell S. Priority list of research areas for radiological nuclear threat countermeasures. Radiat Res. 2005; 163(1):115-23. (Pubitemid 40039952)
2. Stone HB, Moulder JE, Coleman CN, Ang KK, Anscher MS, Barcellos-Hoff MH, et al. Models for evaluating agents intended for the prophylaxis, mitigation and treatment of radiation injuries. Report of an NCI Workshop, December 3-4, 2003. Radiat Res. 2004; 162(6):711-28. (Pubitemid 39552901)
3. Food and Drug Administration. New drug and biological drug products: evidence needed to demonstrate effectiveness of new drugs when human efficacy studies are not ethical or feasible. Fed Regist. 2002; 67:37988-98.
4. Fliedner TM, Dörr HD, Meineke V. Multi-organ involvement as a pathogenetic principle of the radiation syndromes: a study involving 110 case histories documented in SEARCH and classified as the bases of haematopoietic indicators of effect. BJR Suppl. 2005; 27:1-8.
5. United Nations Scientific Committee on the Effects of Atomic Radiation (UNSCEAR). Report to the General Assembly, Annex J: Exposure and Effects of the Chernobyl Accident. Sources, Effects and Risks of Ionizing Radiation. 2000.
6. Travis EL, Down JD, Holmes SJ, Hobson B. Radiation pneumonitis and fibrosis in mouse lung assayed by respiratory frequency and histology. Radiat Res. 1980; 84(1):133-43. (Pubitemid 10030372)
7. Rubin P, Johnston CJ, Williams JP, McDonald S, Finkelstein JN. A perpetual cascade of cytokines postirradiation leads to pulmonary fibrosis. Int J Radiat Oncol Biol Phys. 1995; 33(1): 99-109.
8. Vujaskovic Z, Feng QF, Rabbani ZN, Samulski TV, Anscher MS, Brizel DM. Assessment of the protective effect of amifostine on radiation-induced pulmonary toxicity. Exp Lung Res. 2002; 28(7): 577-90.
9. Sekine I, Sumi M, Ito Y, Nokihara H, Yamamoto N, Kunitoh H, et al. Retrospective analysis of steroid therapy for radiation-induced lung injury in lung cancer patients. Radiother Oncol. 2006; 80(1): 93-7. (Pubitemid 44226433)
10. Magana E, Crowell RE. Radiation pneumonitis successfully treated with inhaled corticosteroids. South Med J. 2003; 96(5): 521-4. (Pubitemid 38031145)
11. Moulder JE, Robbins ME, Cohen EP, Hopewell JW, Ward WF. Pharmacologic modification of radiation-induced late normal tissue injury. Cancer treatment and research. 1998; 93:129-51.
12. Yakovlev VA, Rabender CS, Sankala H, Gauter-Fleckenstein B, Fleckenstein K, Batinic-Haberle I, et al. Proteomic analysis of radiation-induced changes in rat lung: Modulation by the superoxide dismutase mimetic MnTE-2-PyP(5+). Int J Radiat Oncol Biol Phys. 2010; 78(2):547-54.
13. Vujaskovic Z, Batinic-Haberle I, Rabbani ZN, Feng QF, Kang SK, Spasojevic I, et al. A small molecular weight catalytic metallo-porphyrin antioxidant with superoxide dismutase (SOD) mimetic properties protects lungs from radiation-induced injury. Free Radic Biol Med. 2002; 33(6):857-63. (Pubitemid 35232320)
14. Williams JP, Hernady E, Johnston CJ, Reed CM, Fenton B, Okunieff P, et al. Effect of administration of lovastatin on the development of late pulmonary effects after whole-lung irradiation in a murine model. Radiat Res. 2004; 161(5):560-7. (Pubitemid 40754225)
15. Townsend DM, Pazoles CJ, Tew KD. NOV-002, a mimetic of glutathione disulfide. Expert Opin Investig Drugs. 2008; 17(7): 1075-83.
16. Ward WF, Molteni A, Ts'ao CH. Radiation-induced endothelial dysfunction and fibrosis in rat lung: modification by the angiotensin converting enzyme inhibitor CL242817. Radiat Res. 1989; 117(2):342-50. (Pubitemid 19093104)
17. Ghosh SN, Zhang R, Fish BL, Semenenko VA, Li XA, Moulder JE, et al. Renin-Angiotensin system suppression mitigates experimental radiation pneumonitis. Int J Radiat Oncol Biol Phys. 2009; 75(5):1528-36.
18. Su Y, Yang S, Xiao Z, Wang W, Okunieff P, Zhang L. Triptolide alters mitochondrial functions. Adv Exp Med Biol. 2007; 599:139-46.
19. Para AE, Bezjak A, Yeung IW, Van Dyk J, Hill RP. Effects of genistein following fractionated lung irradiation in mice. Radiother Oncol. 2009; 92(3):500-10.
20. Muggenburg BA, Boecker BB, Hahn FF, McClellan RO. Lung lavage therapy to lessen the biological effects of inhaled 144Ce in dogs. Radiat Res. 1990; 124(2):147-55
21. An YS, Lee E, Kang MH, Hong HS, Kim MR, Jang WS, et al. Substance P stimulates the recovery of bone marrow after the irradiation. J Cell Physiol. 2011; 226(5):1204-13.
22. Food and Drug Administration. Guidance for Industry: Animal Models\Essential Elements to Address Efficacy Under the Animal Rule. In: Center for Drug Evaluation and Research (CDER) Center for Biologics Evaluation and Research (CBER) editor: Office of Communications Division of Drug Information FDA; 2009.
23. International Atomic Energy Agency. Accidental Overexposure of Radiotherapy Patients in Bialystok. Vienna. 2004.
24. Sharplin J, Franko AJ. A quantitative histological study of strain-dependent differences in the effects of irradiation on mouse lung during the early phase. Radiat Res. 1989; 119(1):1-14. (Pubitemid 19197732)
25. Johnston CJ, Hernady E, Reed C, Thurston SW, Finkelstein JN, Williams JP. Early alterations in cytokine expression in adult compared to developing lung in mice after radiation exposure. Radiat Res. 2010; 173(4):522-35.
26. Williams JP, Brown SL, Georges GE, Hauer-Jensen M, Hill RP, Huser AK, et al. Animal models for medical countermeasures to radiation exposure. Radiat Res. 2010; 173(4):557-78.
27. Johnston CJ, Manning C, Hernady E, Reed C, Thurston SW, Finkelstein JN, et al. Effect of total body irradiation on late lung effects: Hidden dangers. Int J Radiat Biol. 2011; 87(8):902-13.
28. Food and Drug Administration. Draft Guidance: Emergency Use Authorization of Medical Products. In: Office of Counterterrorism Policy and Planning, editor: Office of Counterterrorism Policy and Planning (HF-29), Office of the Commissioner, FDA; 2005.
29. Committee for Medicinal Products for Human Use. Guideline on procedures for the granting of a marketing authorisation under exceptional circumstances pursuant to Article 14 (8) of Regulation (EC) No 726/2004. London: European Medicines Agency; 2005.
30. Druckman M. Food and Drug Policy Forum. Should Congress create stronger incentives to develop vaccines and other medical countermeasures against pandemic influenza and bioterrorism. Washington, DC: Food and Drug Law Institute; 2011.
31. DiCarlo AL, Poncz M, Cassatt DR, Shah JR, Czarniecki CW, Maidment BW. Medical countermeasures for platelet regeneration after radiation exposure. Report of a workshop and guided discussion sponsored by the National Institute of Allergy and Infectious Diseases, Bethesda, MD, March 22-23, 2010. Radiat Res. 2011; 176(1):e0001-15.
32. Azoulay E, Canet E, Raffoux E, Lengline E, Lemiale V, Vincent F, et al. Dexamethasone in patients with acute lung injury from acute monocytic leukemia. Eur Respir J. 2011.