PUBLICATIONS

IL-10


Moore KW, de Waal Malefyt R, Coffman RL, O’Garra A. 2001. Interleukin-10 and the interleukin-10 receptor. Annu Rev Immunol 19: 683–765.

Ding, Y, Qin, L, Zamarin, D, Kotenko, SV, Pestka, S, Moore, KW, et al. 2001. Differential IL-10R1 expression plays a critical role in IL-10-mediated immune regulation. J Immunol 167: 6884-6892.

Dang PM-C, Elbim C, Marie J-C, Chiandotto M, Gougerot-Pocidalo M-A, El-Benna J. 2006.  Anti-inflammatory effect of interleukin-10 on human neutrophil respiratory burst involves inhibition of GM-CSF-induced p47PHOX phosphorylation through a decrease in ERK1/2 activity. The FASEB Journal 20(9):1504-1506.

Foey AD, Parry SL, Williams LM. 1998. Regulation of monocyte IL-10 synthesis by endogenous IL-1 and TNF-α: role of the p38 and p42/44 mitogen-activated protein kinases. J Immunol 160, 920–928.

Sawada, M, Suzumura, A, Hosoya, H, Marunouchi, T & Nagatsu, T. 2001. Interleukin-10 Inhibits Both Production of Cytokines and Expression of Cytokine Receptors in Microglia. J Neurochem 72, 1466–1471.


GLIA/PAIN BACKGROUND

Watkins LR, Hutchinson MR, Ledeboer A, Wieseler-Frank J, Milligan ED, Maier SF. Glia as the “bad guys”: Implications for improving clinical pain control and the clinical utility of opioids. Brain Behav Immun. 2007 Feb;21(2):131–46. 

Watkins LR, Hutchinson MR, reviews EMBR, 2007. “Listening” and ‘talking’ to neurons: implications of immune activation for pain control and increasing the efficacy of opioids. Brain Res Rev 2007 Nov;56(1):148–69. 

Watkins LR, Maier SF. Implications of immune-to-brain communication for sickness and pain. Proc Natl Acad Sci USA. National Academy of Sciences; 1999 Jul 6;96(14):7710–3. 

Kwilasz AJ, Grace PM, Serbedzija P, Maier SF, Watkins LR. The therapeutic potential of interleukin-10 in neuroimmune diseases. Neuropharmacology. 2015 Sep;96(Pt A):55–69. 

Sloane E, Langer S, Jekich B, Mahoney J, Hughes T, Frank M, et al. Immunological priming potentiates non-viral anti-inflammatory gene therapy treatment of neuropathic pain. Gene Ther. 2009 Jul 2;16(10):1210–22. 


Sloane EM, Soderquist RG, Maier SF, Mahoney MJ, Watkins LR, Milligan ED. Long-term control of neuropathic pain in a non-viral gene therapy paradigm. Gene Ther. 2009 Apr;16(4):470–5. 


Milligan ED, Penzkover KR, Soderquist RG, Mahoney MJ. Spinal Interleukin-10 Therapy to Treat Peripheral Neuropathic Pain. Neuromodulation: Technology at the Neural Interface. 2012 Jun 1;15(6):520–6. 


Fields R. New culprits in chronic pain. Scientific American Magazine. 2009;301(5):50–7. 

XT-150 FORMULATION


Dengler EC, Alberti LA, Bowman BN, Kerwin AA, Wilkerson JL, Moezzi DR, et al. Improvement of spinal non-viral IL-10 gene delivery by D-mannose as a transgene adjuvant to control chronic neuropathic pain. 2014 May 21;11(1):1–21. 


Vanderwall AG, Noor S, Sun MS, Sanchez JE, Yang XO, Jantzie LL, et al. Effects of spinal non-viral interleukin-10 gene therapy formulated with d-mannose in neuropathic interleukin-10 deficient mice: Behavioral characterization, mRNA and protein analysis in pain relevant tissues. Brain Behav Immun. 2018 Mar;69:91–112. 


IL-10V DNA THERAPY EFFICACY
ACROSS PAIN MODELS


Milligan ED, Sloane EM, Langer SJ, Hughes TS, Jekich BM, Frank MG, et al. Repeated intrathecal injections of plasmid DNA encoding interleukin-10 produce prolonged reversal of neuropathic pain. Pain. 2006 ed. 2006 Dec 15;126(1-3):294–308. 

Sloane E, Ledeboer A, Seibert W, Coats B, van Strien M, Maier SF, et al. Anti-inflammatory cytokine gene therapy decreases sensory and motor dysfunction in experimental Multiple Sclerosis: MOG-EAE behavioral and anatomical symptom treatment with cytokine gene therapy. Brain Behav Immun. 2009 Jan;23(1):92–100. 

Grace PM, Loram LC, Christianson JP, Strand KA, Flyer-Adams JG, Penzkover KR, et al. Behavioral assessment of neuropathic pain, fatigue, and anxiety in experimental autoimmune encephalomyelitis (EAE) and attenuation by interleukin-10 gene therapy. Brain Behav Immun. 2017 Jan;59:49–54. 

Ledeboer A, Jekich BM, Sloane EM, Mahoney JH, Langer SJ, Milligan ED, et al. Intrathecal interleukin-10 gene therapy attenuates paclitaxel-induced mechanical allodynia and proinflammatory cytokine expression in dorsal root ganglia in rats. Brain Behav Immun. 2007 Jul;21(5):686–98.


OA 


Lee AS, Ellman MB, Yan D, Kroin JS, Cole BJ, van Wijnen AJ, et al. A current review of molecular mechanisms regarding osteoarthritis and pain. Gene. Elsevier B.V; 2013 Sep 25;527(2):440–7. 

Kapoor MM, Martel-Pelletier JJ, Lajeunesse DD, Pelletier J-PJ, Fahmi HH. Role of proinflammatory cytokines in the pathophysiology of osteoarthritis. Nat Rev Rheumatol. 2011 Jan 1;7(1):33–42. 

Watkins LR, Chavez RA, Landry R, Fry M, Green-Fulgham SM, Coulson JD, et al. Targeted interleukin-10 plasmid DNA therapy in the treatment of osteoarthritis: Toxicology and pain efficacy assessments. Brain Behav Immun. 2020 Nov;90:155–66. 

HUMAN IL-10 DATA


Backonja MM, Coe CL, Muller DA, Schell K. Altered cytokine levels in the blood and cerebrospinal fluid of chronic pain patients. Journal of neuroimmunology. 2008 Mar;195(1-2):157–63. 


Chernoff AE, Granowitz EV, L Shapiro, E Vannier, G Lonnemann, JB Angel, JS Kennedy, AR Rabson, SM Wolff and CA Dinarello. 1995. A randomized, controlled trial of IL-10 in humans. Inhibition of inflammatory cytokine production and immune responses. J Immunol 154:5492-5499. 


Devière J, Le Moine O, Van Laethem JL, Eisendrath P, Ghilain A, Severs N, Cohard M. 2001. Interleukin 10 reduces the incidence of pancreatitis after therapeutic endoscopic retrograde cholangiopancreatography. Gastroenterology. 120(2):498-505.


Huhn RD, Radwanski E, Gallo J, Affrime MB, Sabo R, Gonyo G, Monge A, Cutler DL. 1997. Pharmacodynamics of subcutaneous recombinant human interleukin-10 in healthy volunteers. Clin Pharmacol Ther. 62(2):171-80.


Huhn RD, Radwanski E, O'Connell SM, Sturgill MG, Clarke L, Cody RP, Affrime MB, Cutler DL. 1996. Pharmacokinetics and immunomodulatory properties of intravenously administered recombinant human interleukin-10 in healthy volunteers. Blood. 87(2):699-705.


Kimball AB, Kawamura T, Tejura K, Boss C, Hancox AR, Vogel JC, Steinberg SM, Turner ML, Blauvelt A. 2002. Clinical and immunologic assessment of patients with psoriasis in a randomized, double-blind, placebo-controlled trial using recombinant human interleukin 10. Arch Dermatol. 138(10):1341-6.

McInnes IB, Illei GG, Danning CL, Yarboro CH, Crane M, Kuroiwa T, Schlimgen R, Lee E, Foster B, Flemming D, Prussin C, Fleisher TA, Boumpas DT. 2001. IL-10 improves skin disease and modulates endothelial activation and leukocyte effector function in patients with psoriatic arthritis. J Immunol 1;167(7):4075-82.


Schreiber S, Fedorak RN, Nielsen OH, Wild G, Williams CN, Nikolaus S, Jacyna M, Lashner BA, Gangl A, Rutgeerts P, Isaacs K, van Deventer SJ, Koningsberger JC, Cohard M, LeBeaut A, Hanauer SB. 2000. Safety and efficacy of recombinant human interleukin 10 in chronic active Crohn's disease. Crohn's Disease IL-10 Cooperative Study Group. Gastroenterology. 119(6):1461-72.


van Deventer SJ, Elson CO, Fedorak RN. 1997. Multiple doses of intravenous interleukin 10 in steroid-refractory Crohn's disease. Crohn's Disease Study Group. Gastroenterology 113(2):383-9.


van Roon J, Wijngaarden S, Lafeber FP, Damen C, van de Winkel J, Bijlsma JW. 2003. Interleukin 10 treatment of patients with rheumatoid arthritis enhances Fc gamma receptor expression on monocytes and responsiveness to immune complex stimulation. J Rheumatol. 30(4):648-51.


DNA THERAPY SAFETY


Prazeres DMF, Monteiro GA. 2014. Plasmid biopharmaceuticals. Microbiol Spectrum 2(6):PLAS-0022-2014.

Ferraro B, Morrow, M, Hutnick NA, Shin TH, Lucke CE, Weiner DB. 2011 Clinical Applications of DNA Vaccines: Current Progress. Clinical Infectious Diseases 2011;53(3):296–302.


PLGA FORMULATION OF IL-10V PLASMID DNA

Sloane EM, Soderquist RG, Maier SF, Mahoney MJ, Watkins LR, Milligan ED. 2009. Long-term control of neuropathic pain in a non-viral gene therapy paradigm. Gene Ther. 16(4):470-5.

Soderquist, R G, et al. 2010. Release of plasmid DNA-encoding IL-10 from PLGA microparticles facilitates long-term reversal of neuropathic pain following a single intrathecal administration. Pharmaceut Res, 27(5): 841–854.


Erin D. Milligan, Ryan G. Soderquist, Stephanie M. Malone, John H. Mahoney, Travis S. Hughes, Stephen J. Langer, Evan M. Sloane, Steven F. Maier, Leslie A. Leinwand, Linda R. Watkins, Melissa J. Mahoney. Intrathecal polymer-based interleukin-10 gene delivery for neuropathic pain. Neuron Glia Biology, 2007, 2, 1–16.

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