Assessment of potential cross-reactivity of human endogenous matrix metalloproteinases with collagenase Clostridium histolyticum antibodies in human sera obtained from patients with dupuytren's contracture

Clinical and Vaccine Immunology

Volumn 19, Issue 4, 2012, Pages 562-569

  Edkins, Thomas J ^a   Koller Eichhorn, Roland ^b   Alhadeff, Jack A ^c   Mayer, Ulrich ^d   Faust, Heinrich ^d   Del Tito, Benjamin J ^e  

^a Edkins Pharma Services LLC   (United States)

^b Koller and Koller LLC   (Switzerland)

^c Protein Therapeutics Consulting   (United States)

^d CELERION   (United States)

^e Auxilium Pharmaceuticals Inc   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

AUX I ANTIBODY; AUX II ANTIBODY; BACTERIUM ANTIBODY; BOVINE IMMUNOGLOBULIN; CLOSTRIDIOPEPTIDASE A; COLLAGENASE 3; ENZYME ANTIBODY; GELATINASE A; INTERSTITIAL COLLAGENASE; MATRIX METALLOPROTEINASE; NEUTROPHIL COLLAGENASE; STROMELYSIN; UNCLASSIFIED DRUG;

ADULT; ANTIBODY DETECTION; ANTIBODY RESPONSE; ARTICLE; BLOOD ANALYSIS; BLOOD SAMPLING; CLINICAL ASSESSMENT; CLINICAL EVALUATION; CLINICAL STUDY; CLOSTRIDIUM HISTOLYTICUM; CONTROLLED STUDY; CROSS REACTION; DRUG SAFETY; DRUG TOLERABILITY; DUPUYTREN CONTRACTURE; ENZYME LINKED IMMUNOSORBENT ASSAY; FEMALE; HUMAN; MAJOR CLINICAL STUDY; MALE; PATIENT SAFETY; PRIORITY JOURNAL; PROTEIN DOMAIN; SEQUENCE ALIGNMENT; SEQUENCE HOMOLOGY; UNSPECIFIED SIDE EFFECT;

AGED; ANTIBODIES, BACTERIAL; CROSS REACTIONS; DUPUYTREN CONTRACTURE; ENZYME-LINKED IMMUNOSORBENT ASSAY; FEMALE; HUMANS; MALE; MATRIX METALLOPROTEINASES; MICROBIAL COLLAGENASE; MIDDLE AGED; SEQUENCE HOMOLOGY, AMINO ACID;

EID: 84859317532     PISSN: 15566811     EISSN: 1556679X     Source Type: Journal    
DOI: 10.1128/CVI.00018-12     Document Type: Article

References (24)

1. Bramhall SR, et al. 2002. Marlmastat as maintenance therapy for patients with advanced gastric cancer: a randomized trial. Br. J. Cancer 86:1864-1870.
2. Brown JJ, Ollier W, Thomson W, Bayat A. 2008. Positive association of HLA-DRB1*15 with Dupuytren's disease in Caucasians. Tissue Antigens 72:166 -170.
3. Butler GS, Overall CM. 2009. Updated biological roles for matrix mettaloproteinases and new "intracellular" substrates revealed by degradomics. Biochemistry 48:10830-10845.
4. Cauwe B, Van den Steen PE, Opdenakker G. 2007. The biochemical, biological and kaleidoscope of cell surface substrates processed by matrix metallproteineases. Crit. Rev. Biochem. Mol. Biol. 42:113-185. (Pubitemid 46911962)
5. Celerion. 2010. Assay development for investigating cross-reactivity of MMP proteins with anti-AUX-I and anti-AUX-II antibodies in clinical samples, report DAA90736/90737. Celerion, Fehraltorf, Switzerland.
6. Chamberlain P. 2008. Presenting an immunogenicity risk assessment to regulatory agencies, vol VIII, p 239-258. In van de Weert M, Møller EH (ed), Immunogenicity of biopharmaceuticals. Springer, New York, NY.
7. Coert JH, Barret Nérin JP, Meek MF. 2006. Results of partial fasciectomy for Dupuytren disease in 261 consecutive patients. Ann. Plastic Surg. 57: 13-17. (Pubitemid 43982245)
8. European Medicines Agency. 2007. Guideline on immunogenicity assessment of biotechnology-derived therapeutic proteins. Document reference EMEA/CHMP/BMWP/14327/2006. European Medicines Agency, London, England.
9. European Medicines Agency. 2011. Xiapex: EPAR summary for the public. European Medicines Agency, London, England. http://www .ema.europa.eu/ema/index. jsp?curl=pages/medicines/human/medicines /002048/human-med-001423.jsp&mid= WC0b01ac058001d124. Accessed 7 March 2012.
10. Foucher G, Medina J, Navarro R. 2003. Percutaneous needle aponeurotomy: complications and results. J. Hand Surg. Br. 28B:427-431. (Pubitemid 37168327)
11. Hurst LC, et al. 2009. Injectable collagenase clostridium histolyticum for Dupuytren's contracture. N. Engl. J. Med. 361:968-979.
12. Kemsley JN. 2009. Analyzing protein drugs. Chem. Eng. News 87:20-23.
13. Kirschner S. 2010. A regulatory perspective on immunogenicity surveillance considerations in the post-approval phase of biotherapeutics. AAPS Biotechnol. Conf., San Francisco, CA. American Association of Pharmaceutical Scientists, Arlington, VA.
14. Krzeski P, et al. 2007. Development of musculoskeletal toxicity without clear benefit after administration of PG-116800, a matrix metalloproteinase inhibitor, to patients with knee osteoarthritis: a randomized, 12-month, double-blind, placebo-controlled study. Arthritis Res. Ther. 9:R109.
15. Matsushita O, Okabe A. 2001. Clostridial hydrolytic enzymes degrading extracellular components. Toxicon 39:1769-1780. (Pubitemid 32787008)
16. Mire-Sluis AR, et al. 2004. Recommendations for the design and optimization of immunoassays used in the detection of host antibodies against biotechnology products. J. Immunol. Methods 289:1-16. (Pubitemid 38900899)
17. Mookhtiar KM, Van Wart HE. 1992. Clostridium histolyticum collagenases: a new look at some old enzymes. Matrix Suppl. 1:116-126.
18. Rowley DI, Couch M, Chesney RB, Norris SH. 1984. Assessment of percutaneous fasciotomy in the management of Dupuytren's contracture. J. Hand Surg. Br. 9:163-164.
19. Shankar G, et al. 2008. Recommendations for the validation of immunoassays used for detection of host antibodies against biotechnology products. J. Pharm. Biomed. Anal. 48:1267-1281.
20. Smith AC. 1991. Diagnosis and indications for surgical treatment. Hand Clinics 7:635-642.
21. Starkweather KD, et al. 1996. Collagenase in the treatment of Dupuytren's disease: an in vitro study. J. Hand Surg. 21A:490-495. (Pubitemid 26166850)
22. Thrailkill KM, et al. 2005. Physiological matrix metalloproteinase concentrations in serum during childhood and adolescence, using Luminex Multiplex technology. Clin. Chem. Lab. Med. 43:1392-1399. (Pubitemid 41752571)
23. U.S. Food and Drug Administration. 2011. Drugs @ FDA: FDA approved drug products. U.S. Food and Drug Administration, Rockville, MD. http: //www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search. DrugDetails. Accessed 9 October 2011.
24. U.S. Food and Drug Administration. 2009. Draft guidance for industry. Assay development for immunogenicity testing of therapeutic proteins. U.S. Department of Health and Human Services, Food and Drug Administration, Rockville, MD.