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(12) United States Patent (10) Patent No.: US 9,371,392 B2 Tabuteau (45) Date of Patent: *Jun

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(12) United States Patent (10) Patent No.: US 9,371,392 B2 Tabuteau (45) Date of Patent: *Jun US009371392B2 (12) United States Patent (10) Patent No.: US 9,371,392 B2 Tabuteau (45) Date of Patent: *Jun. 21, 2016 (54) TREATMENT OF COMPLEX REGIONAL 8,859,530 B2 10/2014 Desai PAN.SYNDROME USING DENOSUMAB 8,865,757 B1 10/2014 Tabuteau 8,901,161 B1 12/2014 Tabuteau (71) Applicant: Antecip Bioventures II LLC, New 8,901.9628,901,162 B2B1 12/2014 NormanTabuteau York, NY (US) 2004, OO63670 A1 4, 2004 Fox et al. 2010, 0215743 A1 8, 2010 Leonard (72) Inventor: Herriot Tabuteau, New York, NY (US) 2011/0028435 A1 2/2011 Hanna et al. 2011/0098252 A1 4/2011 Pappagallo 2012fO190647 A1 7/2012 Hanna et al. (73) Assignee: ANTECIP BIOVENTURES II LLC, 2013/0274282 A1 10, 2013 Tabuteau New York, NY (US) 2013/0303485 A1 11/2013 Tabuteau - 2013/0303486 A1 11/2013 Tabuteau (*) Notice: Subject to any disclaimer, the term of this 2013/0303487 A1 11/2013 Tabuteau patent is extended or adjusted under 35 28393. A. 1 58. Easabuteau U.S.C. 154(b) by 0 days. 2014/0051718 A1 2/2014 Tabuteau This patent is Subject to a terminal dis- 2014/0107345 A1 4/2014 Tabuteau claimer. FOREIGN PATENT DOCUMENTS (21) Appl. No.: 14/952,724 WO WO2OO2O87.555 11, 2002 WO WO2005063218 7/2005 (22) Filed: Nov. 25, 2015 WO WO2OO5/107751 11, 2005 WO WO2012O71517 5, 2012 (65) Prior Publication Data US 2016/0075791 A1 Mar 17, 2016 OTHER PUBLICATIONS O O Ohba et al. (2014). Bone. 63:110-120. Related U.S. Application Data Lin et al. (2010). Brain Research Bulletin. 83:284-291. (63) Continuation of application No. 14/812,989, filed on Roudier et al. (2006). Clin. Exp. Metastasis. 23:167-175. Jul. 29, 2015, now Pat. No. 9,205,045, which is a Luger et al. (2001) Cancer Research. 61:4038-4047. continuation of application No. 14/495.732,s - 1s filed on 23.Rasulova et al. (2013) World Journal of Nuclear Medicine 12(1):19 Sep. 24, 2014, now Pat. No. 9,127,069. U.S. Appl. No. 13/894,244, filed May 14, 2013 FirstNamed Inventor: (60) Provisional application No. 62/012,112, filed on Jun. Herriot Tabuteau Assignee: Antecip Bioventures II LLC. 13, 2014, provisional application No. 62/010,754, U.S. Appl. No. 13/894.252, filed May 14, 2013 FirstNamed Inventor: filed on Jun. 11, 2014. Herriot Tabuteau Assignee: Antecip Bioventures II LLC. U.S. Appl. No. 13/894.262, filed May 14, 2013 FirstNamed Inventor: (51) Int. Cl. Herriot Tabuteau Assignee: Antecip Bioventures II LLC. A 6LX39/395 (2006.01) U.S. Appl. No. 13/894,274, filed May 14, 2013 FirstNamed Inventor: Herriot Tabuteau Assignee: Antecip Bioventures II LLC. CR '7. 3.08: U.S. Appl. No. 14/106.291, filed Dec. 13, 2013 FirstNamed Inventor: C07K 6/24 2OO 6. O1 Herriot Tabuteau Assignee: Antecip Bioventures II LLC. ( .01) U.S. Appl. No. 14/279,196, filed May 15, 2014 FirstNamed Inventor: A6 IK9/00 (2006.01) Herriot Tabuteau Assignee: Antecip Bioventures II LLC. A 6LX3/59 (2006.01) U.S. Appl. No. 14/279,206, filed May 15, 2014 FirstNamed Inventor: A6 IK3I/675 (2006.01) Herriot Tabuteau Assignee: Antecip Bioventures II LLC. A61 K39/00 (2006.01) U.S. Appl. No. 14/279.213, filed May 15, 2014 FirstNamed Inventor: (52)52) U.S. C. Herriot Tabuteau Assignee: Antecip Bioventures II LLC. CPC ........... C07K 16/2875 (2013.01); A61 K9/0019 U.S. Appl. No. 14/279,222, filed May 15, 2014 FirstNamed Inventor: (2013.01); A61 K9/0021 (2013.01); A61 K Herriot Tabuteau Assignee: Antecip Bioventures II LLC. 3L/519 (2013 01); A61 K3I/675 (2013 01); U.S. Appl. No. 14/279,226, filed May 15, 2014 FirstNamed Inventor: A6 IK 39/3955 (2013.01); A61 K 45/06 Herriot Tabuteau Assignee: Antecip Bioventures II LLC. (2013.01); C07K 16/241 (2013.01); C07K (Continued) I6/2878 (2013.01); A6 IK 2039/505 (2013.01): A61 K 2039/54 (2013.01); A61K 2039/545 (2013.01); C07K 2317/21 (2013.01); C07K Primary Examiner – Christine J Saoud 2317/30 (2013.01); C07K 2317/76 (2013.01) Assistant Examiner — Jon M Lockard (58) Field of Classification Search (74) Attorney, Agent, or Firm — K&L Gates LLP. Brent A. None Johnson; Louis C. Cullman See application file for complete search history. (56) References Cited (57) ABSTRACT U.S. PATENT DOCUMENTS Disclosed herein are methods of treating pain using compris ing RANK/RANKL antagonists. 8,802,658 B2 8, 2014 Tabuteau 8,822,436 B1 9, 2014 Tabuteau 8,835,650 B1 9, 2014 Tabuteau 30 Claims, 5 Drawing Sheets US 9,371,392 B2 Page 2 (56) References Cited Bingham III et al., Risedronate decreases biochemical markers of cartilage degradation but does not decrease symptoms or slow radio OTHER PUBLICATIONS graphic progression in patients with medical compartment U.S. Appl. No. 14/279,229, filed May 15, 2014 FirstNamed Inventor: osteoarthritis of the knee. Arthritis & Rheumatism, vol. 54, No. 11, Herriot Tabuteau Assignee: Antecip Bioventures II LLC. 2006, 3494-3507. U.S. Appl. No. 14/279,232, filed May 15, 2014 FirstNamed Inventor: Cullen et al., MER-101: a bioavailability study of various GIPET Herriot Tabuteau Assignee: Antecip Bioventures II LLC. formulations in beagle dogs with intraduodenal cannulae. Poster U.S. Appl. No. 14/279,236, filed May 15, 2014 FirstNamed Inventor: Presentation, Nov. 2007. Herriot Tabuteau Assignee: Antecip Bioventures II LLC. De Castro et al., Zoledronic acid to treat complex regional pain U.S. Appl. No. 14/279,241, filed May 15, 2014 FirstNamed Inventor: syndrome type I in adult (case report). Rev. Dor. Sao Paulo, 2011, Herriot Tabuteau Assignee: Antecip Bioventures II LLC. 12(1): 71-73. U.S. Appl. No. 14/336,642, filed Jul. 21, 2014 First Named Inventor: EU Product Label for Zometa, accessed 2013. Herriot Tabuteau Assignee: Antecip Bioventures II LLC. Giles, Risedronate not an Effective Disease Modifier in Knee U.S. Appl. No. 14/456.939, filed Aug. 11, 2014 FirstNamed Inventor: Osteoarthritis. Arthritis News (website) 2006. Herriot Tabuteau Assignee: Antecip Bioventures II LLC. Guo et al., Substance P signaling contributes to the vascular and U.S. Appl. No. 14/457,659, filed Aug. 12, 2014 FirstNamed Inventor: nociceptive abnormalities observed in a tibial fracture rat model of Herriot Tabuteau Assignee: Antecip Bioventures II LLC. complex regional pain syndrome type I. Pain 108 (2004) 95-107. U.S. Appl. No. 14/481,097, filed Sep. 9, 2014 First Named Inventor: Kingery et al., A Substance P receptor (NK1) antagonist can reverse Herriot Tabuteau Assignee: Antecip Bioventures II LLC. vascular and nociceptive abnormalities in a rat model of complex U.S. Appl. No. 14/495.732, filed Jan. 26, 2015 FirstNamed Inventor: regional pain syndrome type II. Pain 104 (2003) 75-84. Herriot Tabuteau Assignee: Antecip Bioventures II LLC. Laslett, Extended report: Zoledronic acid reduces knee pain and bone U.S. Appl. No. 14/530,556, filed Oct. 31, 2014 FirstNamed Inventor: marrow lesions over 1 year: a randomized controlled trial. Ann. Herriot Tabuteau Assignee: Antecip Bioventures II LLC. Rheum. Dis. 2012, 71: 1322-1328. U.S. Appl. No. 14/536,526, filed Jan. 28, 2015 FirstNamed Inventor: Leonard et al., MER-101 Tablets: a pilot bioavailability study of a Herriot Tabuteau Assignee: Antecip Bioventures II LLC. novel oral formulation of Zoledronic acid. Poster Presentation, Oct. U.S. Appl. No. 14/538,709, filed Nov. 11, 2014 FirstNamed Inventor: 2007. Herriot Tabuteau Assignee: Antecip Bioventures II LLC. Leonard et al., Safety Profile of Zoledronic acid in a novel oral U.S. Appl. No. 14/540.333, filed Nov. 13, 2014 FirstNamed Inventor: formulation. Poster Presentation, Nov. 2009. Herriot Tabuteau Assignee: Antecip Bioventures II LLC. Leonard et al., Studies of bioavailability and food effects of MER U.S. Appl. No. 14/604,524, filed Jan. 23, 2015 FirstNamed Inventor: 101 Zoledronic Acid Tablets in Postmenopausal Women. Poster Pre Herriot Tabuteau Assignee: Antecip Bioventures II LLC. sentation, Oct. 2009. U.S. Appl. No. 14/605,822, filed Jan. 26, 2015 FirstNamed Inventor: McHugh et al., MER-101-03. A multi center, phase II study to com Herriot Tabuteau Assignee: Antecip Bioventures II LLC. pare MER-101 20mg tablets to intravenous Zometa 4mg in prostate U.S. Appl. No. 14/607.947, filed Jan. 28, 2015 FirstNamed Inventor: cancer patients. Poster Presentation, May 2009. Herriot Tabuteau Assignee: Antecip Bioventures II LLC. Nagae et al., Acidic microenvironment created by osteoclasts causes U.S. Appl. No. 14/607.985, filed Jan. 28, 2015 FirstNamed Inventor: bone pain associated with tumor colonization. J. Bone Miner. Metab. Herriot Tabuteau Assignee: Antecip Bioventures II LLC. (2007) 25:99-104. U.S. Appl. No. 14/625.457, filed Feb. 18, 2015 FirstNamed Inventor: Nagae et al., Osteoclasts play a part in pain due to the inflammation Herriot Tabuteau Assignee: Antecip Bioventures II LLC. adjacent to bone. Bone 39 (2006) 1107-1115. U.S. Appl. No. 14?635,857, filed Mar. 2, 2015 First Named Inventor: Nagakura et al., Allodynia and hyperalgesia in adjuvant-induced Herriot Tabuteau Assignee: Antecip Bioventures II LLC. arthritic rats: time course of progression and efficacy of analgesics. U.S. Appl. No. 14/639,013, filed Mar. 13, 2015 FirstNamed Inventor: The Journal of Pharmacology and Experimental Therapeutics 306: Herriot Tabuteau Assignee: Antecip Bioventures II LLC. 490-497, 2003. U.S. Appl. No. 14/686,551, filed Apr. 14, 2015 FirstNamed Inventor: Orazol(R): Novel approach to adjuvant therapy for improving out Herriot Tabuteau Assignee: Antecip Bioventures II LLC. comes in breast cancer. Merrion Pharmaceuticals, accessed 2013. Chandler, Labeling of unit dose packages of drugs, Department of Reid et al., Intravenous Zoledronic Acid in Postmenopausal Women Pharmacy Policy, University of Kentucky Hospital, Chandler Medi with Low Bone Mineral Density.
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