Drug – bio-affecting and body treating compositions – Antigen – epitope – or other immunospecific immunoeffector – Hormone or other secreted growth regulatory factor,...
Reexamination Certificate
2008-04-01
2008-04-01
Li, Ruixiang (Department: 1646)
Drug, bio-affecting and body treating compositions
Antigen, epitope, or other immunospecific immunoeffector
Hormone or other secreted growth regulatory factor,...
C514S012200, C530S324000
Reexamination Certificate
active
07351414
ABSTRACT:
The invention relates to a method for increasing the toughness and/or stiffness of bone and/or reducing the likelihood and/or severity of bone fracture by administering a parathyroid hormone. The method can be employed to increase toughness or stiffness of bone at a site of a potential or actual trauma, such as the hip or spine of a person at risk of or suffering from osteoporosis. The method of the invention can reduce the incidence of vertebral fracture, reduce the incidence of multiple vertebral fractures, reduce the severity of vertebral fractur and/or reduce the incidence of non-vertebral fracture.
REFERENCES:
patent: 4086196 (1978-04-01), Tregear
patent: 4698328 (1987-10-01), Neer et al.
patent: 5510370 (1996-04-01), Hock
patent: 6258778 (2001-07-01), Rodgers et al.
patent: 6569442 (2003-05-01), Gan et al.
patent: 6770623 (2004-08-01), Chang et al.
patent: 6977077 (2005-12-01), Hock et al.
patent: 7144861 (2006-12-01), Chang et al.
patent: 7163684 (2007-01-01), Gaich et al.
patent: 2006/0094642 (2006-05-01), Gaich et al.
patent: 0 497 915 (1995-04-01), None
patent: 1 059 933 (2003-01-01), None
patent: 08073376 (1996-03-01), None
patent: 08310965 (1996-11-01), None
patent: WO 96/35422 (1996-11-01), None
patent: WO 98/14478 (1998-04-01), None
patent: WO 99/12561 (1999-03-01), None
patent: WO 01/22093 (2001-03-01), None
U.S. Appl. No. 10/443,693, filed May 22, 2003, Hock et al.
U.S. Appl. No. 11/541,862, filed Oct. 2, 2006, Chang, et al.
U.S. Appl. No. 11/541,863, filed Oct. 2, 2006, Chang, et al.
Andreassen, TT, et al., “In Old Rats Intermittent Parathyroid Hormone (1-34) Treatment Increases Callus Formation and Mechanical Strength of Healing Fractures,”Department of Connective Tissue Biology, University of Aarhus, Denmark, ASBMR 21stAnnual Meeting, S417.
Boyce, RW, et al., “Effects of Intermittent hPTH(1-34) Alone and in Combination with 1,25(OH)2D3or Risedronate on Endosteal Bone Remodeling in Canine Cancellous and Cortical Bone,”Journal of Bone and Mineral Research, vol. 11, No. 5, pp. 600-613, (1996).
Chapuy, M, et al., “Vitamin D3and Calcium to Prevent Hip Fractures in Elderly Women,”The New England Journal of Medicine, vol. 327, No. 23, pp. 1637-1641, (1992).
Chapuy, MC, et al., “Biochemical effects of calcium and vitamin D supplementation in elderly, institutionalized, vitamine D-deficient patients,”Rev Rhum Engl Ed, vol. 63, No. 2, pp. 135-140, (Feb. 1996).
Clinical Investigator's Brochure dated Jun. 30, 1995.
Clinical Study Main Report: Safety and Pharmacological Effects of LY333334 on Biochemical Markers of Bone Metabolism in Healthy, Postmenopausal Women.
Conference Report, “Consensus Development Conference: Diagnosis, Proohylaxis, and Treatment of Osteoporosis,”The American Journal of Medicine, vol. 94, pp. 646-650, (Jun. 1993).
Cosman, F, et al., “Estrogen Protection Against Bone Resorbing Effects of Parathyroid Hormone Infusion,”Annals of Internal Medicine, vol. 118, No. 5, 337-343 (1993).
Cosman, F, et al., “Is Parathyroid Hormone a Therapeutic Option for Osteoporosis? A Review of the Clinical Evidence,”Calcified Tissue International, vol. 62, 475-480 (1998).
Dawson-Hughes, B, et al., “Effect of Calcium and Vitamin D Supplementation on Bone Density in Men and Women 65 years of age or Older,”New England Journal of Medicine, vol. 337, No. 10, 1197, pp. 670-676, (Sep. 4, 1997).
Delmas, PD, “Treatment of postmenopausal osteoporosis,”The Lancet, vol. 359, pp. 2018-2026, (Jun. 8, 2002).
Dempster, DW, et al., “Anabolic Actions of Parathyroid Hormone on Bone,”Endocrine Reviews, vol. 14, No. 6, 690-709 (1993).
Ejerstad, C, et al., “Human Parathyroid Hormone (134) and (184) Increase the mechanical Strength and Thickness of Cortical Bone in Rats,”Journal of Bone and Mineral Research, vol. 3, No. 9, 1097-1101 (1993).
Finkelstein, JS, et al., “Increases in bone density after discontinuation of long-term GnRH analog and PTH administration in women with endometriosis,”Journal of Bone and Mineral Research, vol. 23, Supplement No. 5, F459 Abstract, S518 (1998).
Finkelstein, JS, et al., “Increases in Bone Mineral Density after Discontinuation of Daily Human Parathyroid Hormone and Gonadotriopin-Releasing Hormone Analog Administration in Women with Endometriosis,”The Journal of clinical Endocrinology&Metabolism, vol. 84, No. 4, 1214-1219 (1999).
Finkelstein, JS, et al., “Parathyroid Hormone for the Prevention of Bone Loss Induced by Estrogen Deficiency,”The New England Journal of Medicine, vol. 331, No. 24, 1618-1623 (1994).
Finkelstein, JS, et al., “Prevention of Estrogen Deficiency-Related Bone Loss With Human Parathyroid Hormone-(1-34),”JAMA, Vo.. 280, No. 12, 1067-1073 (1998).
Fraser, DR, B.E.C. Nordin (Ed.), Calcium-Regulating Hormones: Vitamin D, Chapter 2, pp. 27-41.
Fujita, T, et al., “Parathyroid Hormone in the Treatment of Osteoporosis,”BioDrugs, vol. 15, No. 1, pp. 721-728, (2001).
Fujita, T, et al., “Effect of an Intermittent Weekly dose of Human Parathyroid Hormone (1-34) on Osteoporosis: A Randomized Double-masked Prospective Study Using Three Dose Levels,”Osteoporosis International, vol. 9, 296-306 (1999).
Fukunaga, M, et al., “Effect of a Small Dose of Human Parathyroid Hormone (1-34) on Bone Mass in the Lumbar Vertebrae in Patients with Senile Osteoporosis,” pp. 3371-3382, (1997).
Hesch, RD, et al., “Increase of Vertebral Density by Combination Therapy with Pulsatile 1-38hPTH and Sequential Addition of Cacitonin Nasal Spray in Osteoporotic Patients,”Calcified Tissue International, Vo. 44, 176-180 (1989).
Hesch, RD, et al., “Results of a Stimulatory Therapy of Low Bone Metabolism in Osteoporosis with (1-38) hPTH and Diphosphonate EHDP,”Klinische Wochen Shrift, vol. 66, 976-984 (1988).
Hesp, R, et al., “The Relationship Between Changes in Femoral Bone Density and Calcium Balance in Patents with Involutional Osteoporosis Treated with Human Parathyroid Hormone Fragment (hPTH 1034),”Metabolic Bone Disease&Related Research, vol. 2, 331-334 (1981).
Hirano T, et al., “Anabolic Effects of Human Biosynthetic Parathyroid Hormone Fragment (1034), LY333334, on Remodeling and Mechanical Properties of Cortical Bone in Rabbits,”Journal of bone and Mineral Research, vol. 14, No. 4, 536-545 (1999).
Hodsman, AB, et al., “A Randomized Controlled Trial to Compare the Efficacy of Cyclical Parathyroid Hormone Versus Cyclical Parathyroid Hormone and Sequential Cacitonin to Improve Bone Mass in Postmenopausal Women with Osteoporosis,”Journal of Clinical Endocrinology and Metabolism, vol. 82, No. 2, 620-628 (1997).
Hodsman, AB, et al., “Parathyroid Hormone: The Clinical Experience and Prospects,” Chapter 4, 83-108 (1998).
Holzer, G, et al., “Parathyroid Hormone Enhances Fracture Healing”, Clinical Orthopaedics and Related Research, No. 366, pp. 258-263 (1999).
Jerome, CP, et al., “Effect of Treatment for 3 Months With Human Parathyroid Hormone 1-34 Peptide in Ovariectomized Cynomolgus Monkeys (Macaca fascicularis),”Bone, vol. 17, No. 4, Supplement, 415S-420S, (Oct. 1995).
Jerome, CP, et al., “Development of Osteopenia in Ovariectomized Cynomolgus Monkeys,”Bone, vol. 17, No. 4, Supplment, pp. 403S-408S, (Oct. 1995).
Kalu, DN, et al., “Parathyroid Hormone and Experimental Osteosclerosis,”The Lancet, Jun. 27, pp. 1363-1366, (1970).
Kim, HW, et al., “Effect of Recombinant Human (1-84) Parathyroid Hormone on Fracture Healing in Ovariectomized Rats”, 43rdAnnual Mtg., Orthopaedic Research Society, San Francisco, CA., (Feb. 9-13, 1997).
Lane, N, et al., “Parathyroid Hormone Treatment Can Reverse Corticosteroid-induced Osteoporosis,”J. Clin. Invest., vol. 102, No. 8, 1627-1633 (Oct. 1998).
Lilly Research Laboratories, “Teriparatide Injection NDA 21-318; Endocrinolo
Dere Willard H.
Gaich Gregory A.
Hock Janet M.
Eli Lilly and Company
Li Ruixiang
Wiskerchen MaryAnn
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