Drug – bio-affecting and body treating compositions – Immunoglobulin – antiserum – antibody – or antibody fragment,... – Monoclonal antibody or fragment thereof
Reexamination Certificate
2001-01-17
2003-10-21
Spector, Lorraine (Department: 1647)
Drug, bio-affecting and body treating compositions
Immunoglobulin, antiserum, antibody, or antibody fragment,...
Monoclonal antibody or fragment thereof
C424S134100, C424S143100, C514S002600, C514S012200
Reexamination Certificate
active
06635250
ABSTRACT:
DESCRIPTION
Technical Field
The present invention relates to the use of a TNF-&agr; inhibitor in the preparation of pharmaceutical compositions for the treatment of nerve root injury, as well as a method for treating nerve root injury.
The object of the present invention is to obtain a possibility to treat nerve root injury induced by disk herniation, which may turn up as radiating pain into the arm or leg (sciatica), by blocking disk related cytokines.
BACKGROUND OF THE INVENTION
Disk herniation is a troublesome disorder, which can cause pronounced pain and muscle dysfunction, and thereby loss of ability to work. A herniation may occur in any disk in the spine but herniations in the lumbar and the cervical spine are most common. A disk herniation in the cervical spine may induce radiating pain and muscle dysfunction in the arm and herniation in the lumbar spine may induce radiating pain and muscle dysfunction in the leg. The radiating pain in the leg is generally referred to a “sciatica”. Disk herniation will cause trouble to a varying degree, and the pain may last for one or two months or in severe cases up to 6 months. The arm or leg pain that can occur as a result of disk herniation can be very intense and may thus affect the individual patient's whole life situation during the sickness period.
U.S. Pat. No. 5,703,092 discloses the use of dydroxamic acid compounds and carbocyclic acids as metalloproteinase and TNF inhibitors, and in particular in treatment of arthritis and other related inflammatory diseases. No use of these compounds for the treatment of nerve root injuries is disclosed or hinted at.
U.S. Pat. No. 4,925,833 discloses the use of tetracyclines to enhance bone protein syntheses, and treatment of osteoporosis.
U.S. Pat. No. 4,666,897 discloses inhibition of mammalian collagenolytic enzymes by tetracyclines. The collagenolytic activity is manifested by excessive bone resorption, periodontal disease, rheumatoid arhritis, ulceration of cornea, or resorption of skin or other connective tissue collagen.
Neither of these latter two documents mentions nerve root injury or the treatment thereof.
DESCRIPTION OF THE PRESENT INVENTION
It has now surprisingly been shown possible to be able to treat nerve root injuries, or at least alleviate the symptoms of nerve root injuries by using a pharmaceutical composition comprising an therapeutically active amount of a TNF-&agr; inhibitor selected from the group consisting of metalloproteinase inhibitors excluding methylprenisolone, tetracyclines including chemically modified tetracyclines, quinolones, corticosteroids, thalidomide, lazaroides, pentoxyphylline, hydroxamic acid derivatives, napthopyrans, soluble cytokine receptors, monoclonal antibodies towards TNF-&agr;, amrinone, pimobendan, vesnarinone, phosphodiesterase III inhibitors, lactoferrin and lactoferrin derived analogous, and melatonin in the form of bases or addition salts together with a pharmaceutically acceptable carrier.
The therapeutically effective amount is a dosage normally used when using such compounds for other therapeutic uses. Many of these drugs are commercially known registered drugs.
Compounds that possess this activity are tetracyclines, such-as tetracycline, doxycycline, lymecycline, oxytetracycline, minocycline, and chemically modified tetracyclines dedimethylaminotetracycline, hydroxamic acid compounds, carbocyclic acids and derivatives, thalidomide, lazaroides, pentoxyphylline, napthopyrans, soluble cytokine receptors, monoclonal antibodies towards TNF-&agr;, amrinone, pimobendan, vesnarinone, phosphodiesterase III inhibitors, lactoferrin and lactoferrin derived analogous, melatonin, norfloxacine, ofloxacine, ciprofloxacine, gatifloxacine, pefloxacine, lomefloxacine, and temafioxacine. These can be present as bases or in the form of addition salts, whichever possesses the best pharmaceutical effect, and best property to be brought into a pharmaceutical suitable composition.
Further, the active component comprises a substance inhibiting a compound trigged by the release of TNF-&agr;, such as interferon-gamma, interleukin-1, and nitrogen oxide (NO) in the form of base or addition salts.
The invention further relates to a method for inhibiting the symptoms of nerve root injury.
The effects of doxycycline, soluble cytokine-receptors, and monoclonal cytokine-antibodies have been studied and the methods used and results obtained are disclosed below.
REFERENCES:
patent: 4666897 (1987-05-01), Golub et al.
patent: 4925833 (1990-05-01), McNamara et al.
patent: 5703092 (1997-12-01), Xue et al.
patent: 6015557 (2000-01-01), Tobinick et al.
patent: 6177077 (2001-01-01), Tobinick
Wang et al., J. of Neuroimmunology, 69(1996), 151-156.*
Sommer et al., Neuroscience Letters, 237 (1997), 45-48.*
Peter Wehling, “Antizytokine gegen Entzündung und Schmerz” (“Anticytokines against Inflamation and Pain”), Orthopädische Nachrichten, p. 16, Jan. 1998, Biermann Verlag GmbH, Köln, Germany, http://www.arthrose-ischias.de/ftp/presse_2.pdf, translation included.
“Körpereigener Immunstoff soll bei Therapie helfen” (“The Body's Own Toxoids Help in Therapy”), Dec. 12, 1999, http://www.rp-online.de
ews/wissenschaft/1999-1230/bandscheibenvorfall.html, translation included.
P. Wehling, “The Use of Cytokine Antagonists in the Treatment of Lumbar Radicular Compression: Pathophysiological Background, Safety and 3 Year Clinical Experience”, Abstracts from the International Society for the Study of the Lumpar Spine conference held in Adelaide, Australia, Apr. 9-13, 2000.
Wehling et al., Information Orthokin, “Die Behandlung von Eshias, Arthrose und Rheumatoider Arthrisis mit Orthokin®”, Wissenschaftliche Informationen (Patient Information Paper), relevant portions translated.
Wehling, Wissenschaftliches Programm (Scientific Program), Jun. 18, 1999, “Epidural Injectin with a New Autologous Interleukin-1 Receptor-Antagonist-Protein (IL-1 ra) at Radicular Compression: Pathophysiology, Safety and Clinical Results”, http://medweb.uni-muenster.de/institute/orth/versanstaltungen/99-06-18v.html, relevant portions translated.
U. Schlumpf et al., “Acute Lumbar Disk Displacement with Nerve Root Compression. Indications for Peridural Steroid Injection”,Schweizerische Rundschau Fur Medizin Praxis,(Feb. 18, 1997) 86 (8) 292-5 (Abstract of STN International, File MEDLINE, Accession No. 97218877).
S. Schenk et al., “Intrathecal Cortison Injection in Lumbar Disc Problems”,Archiv Fur Orthopadische Und Unfall-Chirurgie,(Jun. 18, 1976) 85 (1) 21-31 (Abstract of STN International, File MEDLINE, Accession No. 76231109).
D. Pennica et al., “Cardiotrophin-1, a Cytokine Present in Embryonic Muscle, Supports Long-Term Survival of Spinal Motoneurons”,Neuron,(Jul. 1996) 17 (1) 63-74 (Abstract of STN International, File MEDLINE, Accession No. 96310878).
C. Sommer et al., “A Metalloprotease-Inhibitor Reduces Pain Associated Behavior in Mice with Experimental Neuropathy”,Neuroscience Letters,(Nov. 14, 1997) 237 (1) 45-8 (Abstract of STN International, File MEDLINE, Accession No. 98068711).
C. Sommer et al., “The Effect of Thalidomide Treatment on Vascular Pathology and Hyperalgesia Caused by Chronic Constriction in Injury of Rat Nerve”,Pain,(Jan. 1998) 74 (1) 83-91 (Abstract of STN International, File MEDLINE, Accession No. 98173500).
J. Kraemer et al., “Lumbar Epidural Perineural Injection: A New Technique”,European Spine Journal,(1997) 6/5 (357-361) (Abstract of STN International, File MEDLINE, Accession No. 97339851).
K. Olmarker et al., “Inflammatogenic Properties of Nucleus Pulposus”,Spine,Mar. 15, 1995;20(6):665-0 (Abstract of STN International, File MEDLINE, Accession No. 95328017).
K. Olmarker et al., “Tumor Necrosis Factor Alpha and Nucleus-Pulposus-Induced Nerve Root Injury”,Spine,(Dec. 1, 1998) 23 (23) 2538-44 (Abstract of STN International, File MEDLINE, Accession No. 99071916).
K. Olmarker et al., “Effects of Methylprednisolone on Nucleus Pulposus-Induced Nerve Root Injury”,Spine,vol. 19, No. 16, pp. 1803-1808 (1994).
W. Mixter et al., “Rupture of the Intervertebral Disc with Involvement of
Olmarker Kjell
Rydevik Björn
A+ Science AB (publ)
Burns Doane Swecker & Mathis L.L.P.
Seharaseyon Jegatheesan
LandOfFree
Use of certain metalloproteinase inhibitors for treating... does not yet have a rating. At this time, there are no reviews or comments for this patent.
If you have personal experience with Use of certain metalloproteinase inhibitors for treating..., we encourage you to share that experience with our LandOfFree.com community. Your opinion is very important and Use of certain metalloproteinase inhibitors for treating... will most certainly appreciate the feedback.
Profile ID: LFUS-PAI-O-3166627