Evaluation of cardiovascular parameters in cynomolgus monkeys following IV administration of LBR-101, a monoclonal antibody against calcitonin gene-related peptide

References

• Goadsby PJ, Edvinsson L. The trigeminovascular system and migraine: studies characterizing cerebrovascular and neuropeptide changes seen in humans and cats. Ann Neurol 1993; 33:48 - 56; http://dx.doi.org/10.1002/ana.410330109; PMID: 8388188
   PubMed Web of Science ®Google Scholar
• Edvinsson L, Goadsby PJ. Extracerebral manifestations in migraine. A peptidergic involvement?. J Intern Med 1990; 228:299 - 304; http://dx.doi.org/10.1111/j.1365-2796.1990.tb00236.x; PMID: 2266336
   PubMed Web of Science ®Google Scholar
• Goadsby PJ, Edvinsson L, Ekman R. Vasoactive peptide release in the extracerebral circulation of humans during migraine headache. Ann Neurol 1990; 28:183 - 7; http://dx.doi.org/10.1002/ana.410280213; PMID: 1699472
   PubMed Web of Science ®Google Scholar
• Lassen LH, Haderslev PA, Jacobsen VB, Iversen HK, Sperling B, Olesen J. CGRP may play a causative role in migraine. Cephalalgia 2002; 22:54 - 61; http://dx.doi.org/10.1046/j.1468-2982.2002.00310.x; PMID: 11993614
   PubMed Web of Science ®Google Scholar
• Ho TW, Ferrari MD, Dodick DW, Galet V, Kost J, Fan X, Leibensperger H, Froman S, Assaid C, Lines C, et al. Efficacy and tolerability of MK-0974 (telcagepant), a new oral antagonist of calcitonin gene-related peptide receptor, compared with zolmitriptan for acute migraine: a randomised, placebo-controlled, parallel-treatment trial. Lancet 2008; 372:2115 - 23; http://dx.doi.org/10.1016/S0140-6736(08)61626-8; PMID: 19036425
   PubMed Web of Science ®Google Scholar
• Hewitt DJ, Aurora SK, Dodick DW, Goadsby PJ, Ge YJ, Bachman R, Taraborelli D, Fan X, Assaid C, Lines C, et al. Randomized controlled trial of the CGRP receptor antagonist MK-3207 in the acute treatment of migraine. Cephalalgia 2011; 31:712 - 22; http://dx.doi.org/10.1177/0333102411398399; PMID: 21383045
   PubMed Web of Science ®Google Scholar
• Olesen J, Diener HC, Husstedt IW, Goadsby PJ, Hall D, Meier U, Pollentier S, Lesko LM, BIBN 4096 BS Clinical Proof of Concept Study Group. Calcitonin gene-related peptide receptor antagonist BIBN 4096 BS for the acute treatment of migraine. N Engl J Med 2004; 350:1104 - 10; http://dx.doi.org/10.1056/NEJMoa030505; PMID: 15014183
   PubMed Web of Science ®Google Scholar
• Silberstein SD. Emerging target-based paradigms to prevent and treat migraine. Clin Pharmacol Ther 2013; 93:78 - 85; http://dx.doi.org/10.1038/clpt.2012.198; PMID: 23212108
   PubMed Web of Science ®Google Scholar
• Hoffmann J, Goadsby PJ. New Agents for Acute Treatment of Migraine: CGRP Receptor Antagonists, iNOS Inhibitors. Curr Treat Options Neurol 2012; 14:50 - 9; http://dx.doi.org/10.1007/s11940-011-0155-4; PMID: 22090312
   PubMed Web of Science ®Google Scholar
• Wu H, Dall’Acqua WF. Humanized antibodies and their applications. Methods 2005; 36:1 - 2; http://dx.doi.org/10.1016/j.ymeth.2005.02.001; PMID: 15848069
   PubMed Web of Science ®Google Scholar
• Allen DM, Chen LE, Seaber AV, Urbaniak JR. Calcitonin gene-related peptide and reperfusion injury. J Orthop Res 1997; 15:243 - 8; http://dx.doi.org/10.1002/jor.1100150213; PMID: 9167627
   PubMed Web of Science ®Google Scholar
• Källner G, Gonon A, Franco-Cereceda A. Calcitonin gene-related peptide in myocardial ischaemia and reperfusion in the pig. Cardiovasc Res 1998; 38:493 - 9; http://dx.doi.org/10.1016/S0008-6363(98)00016-9; PMID: 9709411
   PubMed Web of Science ®Google Scholar
• Lynch JJ Jr., Detwiler TJ, Kane SA, Regan CP. Effect of calcitonin gene-related peptide receptor antagonism on the systemic blood pressure responses to mechanistically diverse vasomodulators in conscious rats. J Cardiovasc Pharmacol 2010; 56:518 - 25; http://dx.doi.org/10.1097/FJC.0b013e3181f5d414; PMID: 20729756
   PubMed Web of Science ®Google Scholar
• Supowit SC, Ethridge RT, Zhao H, Katki KA, Dipette DJ. Calcitonin gene-related peptide and substance P contribute to reduced blood pressure in sympathectomized rats. Am J Physiol Heart Circ Physiol 2005; 289:H1169 - 75; http://dx.doi.org/10.1152/ajpheart.00973.2004; PMID: 15879482
   PubMed Web of Science ®Google Scholar
• Chan KY, Edvinsson L, Eftekhari S, Kimblad PO, Kane SA, Lynch J, Hargreaves RJ, de Vries R, Garrelds IM, van den Bogaerdt AJ, et al. Characterization of the calcitonin gene-related peptide receptor antagonist telcagepant (MK-0974) in human isolated coronary arteries. J Pharmacol Exp Ther 2010; 334:746 - 52; http://dx.doi.org/10.1124/jpet.110.165993; PMID: 20573757
   PubMed Web of Science ®Google Scholar
• Lynch JJ, Shen YT, Pittman TJ, Anderson KD, Koblan KS, Gould RJ, Regan CP, Kane SA. Effects of the prototype serotonin 5-HT(1B/1D) receptor agonist sumatriptan and the calcitonin gene-related peptide (CGRP) receptor antagonist CGRP(8-37) on myocardial reactive hyperemic response in conscious dogs. Eur J Pharmacol 2009; 623:96 - 102; http://dx.doi.org/10.1016/j.ejphar.2009.09.018; PMID: 19766109
   PubMed Web of Science ®Google Scholar
• Van der Schueren BJ, Blanchard R, Murphy MG, Palcza J, De Lepeleire I, Van Hecken A, Depré M, de Hoon JN. The potent calcitonin gene-related peptide receptor antagonist, telcagepant, does not affect nitroglycerin-induced vasodilation in healthy men. Br J Clin Pharmacol 2011; 71:708 - 17; http://dx.doi.org/10.1111/j.1365-2125.2010.03869.x; PMID: 21480950
   PubMed Web of Science ®Google Scholar
• Chaitman BR, Ho AP, Behm MO, Rowe JF, Palcza JS, Laethem T, Heirman I, Panebianco DL, Kobalava Z, Martsevich SY, et al. A randomized, placebo-controlled study of the effects of telcagepant on exercise time in patients with stable angina. Clin Pharmacol Ther 2012; 91:459 - 66; http://dx.doi.org/10.1038/clpt.2011.246; PMID: 22278333
   PubMed Web of Science ®Google Scholar
• Bigal ME, Walter S, Rapoport AM. Calcitonin gene-related peptide (CGRP) and migraine current understanding and state of development. Headache 2013; 53:1230 - 44; http://dx.doi.org/10.1111/head.12179; PMID: 23848260
   PubMed Web of Science ®Google Scholar
• Ho TW, Edvinsson L, Goadsby PJ. CGRP and its receptors provide new insights into migraine pathophysiology. Nat Rev Neurol 2010; 6:573 - 82; http://dx.doi.org/10.1038/nrneurol.2010.127; PMID: 20820195
   PubMed Web of Science ®Google Scholar
• Vollbracht S, Rapoport AM. The pipeline in headache therapy. CNS Drugs 2013; 27:717 - 29; http://dx.doi.org/10.1007/s40263-013-0090-x; PMID: 23839594
   PubMed Web of Science ®Google Scholar
• Armour KL, Clark MR, Hadley AG, Williamson LM. Recombinant human IgG molecules lacking Fcgamma receptor I binding and monocyte triggering activities. Eur J Immunol 1999; 29:2613 - 24; http://dx.doi.org/10.1002/(SICI)1521-4141(199908)29:08<2613::AID-IMMU2613>3.0.CO;2-J; PMID: 10458776
   PubMed Web of Science ®Google Scholar
• Zeller J, Poulsen KT, Sutton JE, Abdiche YN, Collier S, Chopra R, Garcia CA, Pons J, Rosenthal A, Shelton DL. CGRP function-blocking antibodies inhibit neurogenic vasodilatation without affecting heart rate or arterial blood pressure in the rat. Br J Pharmacol 2008; 155:1093 - 103; http://dx.doi.org/10.1038/bjp.2008.334; PMID: 18776916
   PubMed Web of Science ®Google Scholar
• Klingbeil C, Hsu DH. Pharmacology and safety assessment of humanized monoclonal antibodies for therapeutic use. Toxicol Pathol 1999; 27:1 - 3; http://dx.doi.org/10.1177/019262339902700101; PMID: 10367664
   PubMed Web of Science ®Google Scholar
• Rodriguez I, Erdman A, Padhi D, Garnett CE, Zhao H, Targum SL, Balakrishnan S, Strnadova C, Viner N, Geiger MJ, et al. Electrocardiographic assessment for therapeutic proteins--scientific discussion. Am Heart J 2010; 160:627 - 34; http://dx.doi.org/10.1016/j.ahj.2010.07.001; PMID: 20934555
   PubMed Web of Science ®Google Scholar
• Bigal ME, Escandon R, Bronson M, Walter S, Sudworth M, Huggins JP, Garzone P. Safety and tolerability of LBR-101, a humanized monoclonal antibody that blocks the binding of CGRP to its receptor: Results of the Phase 1 program. Cephalalgia 2013; 34:483 - 92; http://dx.doi.org/10.1177/0333102413517775; PMID: 24366980
   PubMed Web of Science ®Google Scholar
• Lu JT, Son YJ, Lee J, Jetton TL, Shiota M, Moscoso L, Niswender KD, Loewy AD, Magnuson MA, Sanes JR, et al. Mice lacking alpha-calcitonin gene-related peptide exhibit normal cardiovascular regulation and neuromuscular development. Mol Cell Neurosci 1999; 14:99 - 120; http://dx.doi.org/10.1006/mcne.1999.0767; PMID: 10532808
   PubMed Web of Science ®Google Scholar
• Oh-hashi Y, Shindo T, Kurihara Y, Imai T, Wang Y, Morita H, Imai Y, Kayaba Y, Nishimatsu H, Suematsu Y, et al. Elevated sympathetic nervous activity in mice deficient in alphaCGRP. Circ Res 2001; 89:983 - 90; http://dx.doi.org/10.1161/hh2301.100812; PMID: 11717154
   PubMed Web of Science ®Google Scholar
• Walker CS, Li X, Whiting L, Glyn-Jones S, Zhang S, Hickey AJ, Sewell MA, Ruggiero K, Phillips AR, Kraegen EW, et al. Mice lacking the neuropeptide alpha-calcitonin gene-related peptide are protected against diet-induced obesity. Endocrinology 2010; 151:4257 - 69; http://dx.doi.org/10.1210/en.2010-0284; PMID: 20610563
   PubMed Web of Science ®Google Scholar
• Eftekhari S, Edvinsson L. Possible sites of action of the new calcitonin gene-related peptide receptor antagonists. Ther Adv Neurol Disord 2010; 3:369 - 78; http://dx.doi.org/10.1177/1756285610388343; PMID: 21179597
   PubMedGoogle Scholar
• Raddant AC, Russo AF. Calcitonin gene-related peptide in migraine: intersection of peripheral inflammation and central modulation. Expert Rev Mol Med 2011; 13:e36; http://dx.doi.org/10.1017/S1462399411002067; PMID: 22123247
   PubMed Web of Science ®Google Scholar
• Fisher LA, Kikkawa DO, Rivier JE, Amara SG, Evans RM, Rosenfeld MG, Vale WW, Brown MR. Stimulation of noradrenergic sympathetic outflow by calcitonin gene-related peptide. Nature 1983; 305:534 - 6; http://dx.doi.org/10.1038/305534a0; PMID: 6604878
   PubMed Web of Science ®Google Scholar
• Le Mével JC, Lancien F, Mimassi N, Kermorgant M, Conlon JM. Central ventilatory and cardiovascular actions of calcitonin gene-related peptide in unanesthetized trout. J Exp Biol 2012; 215:1930 - 7; http://dx.doi.org/10.1242/jeb.070177; PMID: 22573772
   PubMed Web of Science ®Google Scholar
• Casey DP, Joyner MJ. Compensatory vasodilatation during hypoxic exercise: mechanisms responsible for matching oxygen supply to demand. J Physiol 2012; 590:6321 - 6; http://dx.doi.org/10.1113/jphysiol.2012.242396; PMID: 22988134
   PubMed Web of Science ®Google Scholar
• Silberstein SD. Practice parameter: evidence-based guidelines for migraine headache (an evidence-based review): report of the Quality Standards Subcommittee of the American Academy of Neurology. Neurology 2000; 55:754 - 62; http://dx.doi.org/10.1212/WNL.55.6.754; PMID: 10993991
   PubMed Web of Science ®Google Scholar
• Guide for the Care and Use of Laboratory Animals. Institute of Laboratory Animal Resources, Commission on Life Sciences, National Research Council, 1996.
   Google Scholar
• Roguin A. Henry Cuthbert Bazett (1885-1950)--the man behind the QT interval correction formula. Pacing Clin Electrophysiol 2011; 34:384 - 8; http://dx.doi.org/10.1111/j.1540-8159.2010.02973.x; PMID: 21091739
   PubMed Web of Science ®Google Scholar