Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Peptide containing doai
Reexamination Certificate
2000-01-12
2001-04-10
Reamer, James H. (Department: 1614)
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
Peptide containing doai
Reexamination Certificate
active
06214791
ABSTRACT:
FIELD OF THE INVENTION
This invention relates to the treatment of multiple sclerosis by ingestion or inhalation of copolymer-1 (as defined below). The present invention also relates to a pharmaceutical composition comprising copolymer-1 used for the treatment of multiple sclerosis, wherein the pharmaceutical composition is formulated for administration by ingestion or inhalation.
BACKGROUND OF THE INVENTION
Copolymer-1, also known as glatiramer acetate and marketed under the tradename Copaxone®, comprises the acetate salts of polypeptides containing L-glutamic acid, L-alanine, L-tyrosine and L-lysine. The average molar fraction of the amino acids are 0.141, 0.427, 0.095 and 0.338, respectively, and the average molecular weight of copolymer-1 is between 4,700 and 11,000 daltons. It is a non-autoantigen which has been demonstrated to suppress experimental allergic encephalomyelitis (EAE) induced by various encephalitogens including mouse spinal cord homogenate (MSCH) which includes all myelin antigens, such as myelin basic protein (MBP) (Sela M et al.,
Bull Inst Pasteur
(1990) 88 303-314), proteolipid protein (PLP) (Teitelbaum D et al.,
J Neuroimmunol
(1996) 64 209-217) and myelin oligodendrocyte glycoprotein (MOG) (Ben-Nun A et al.,
J Neurol
(1996) 243 (Suppl 1) S14-S22) in a variety of species. EAE is an accepted model for multiple sclerosis.
Copolymer-1 has been demonstrated to be active when injected subcutaneously, intra-peritoneally, intravenously or intramuscularly (D. Teitelbaum et al.,
Eur. J. Immunol.
(1971) 1:242-248; D. Teitelbaum et al.,
Eur. J. Immunol.
(1973) 3:273-279).
In phase III clinical trials, daily subcutaneous injections of copolymer-1 were found to slow progression of disability and reduce the relapse rate in exacerbating-remitting multiple sclerosis (K. P. Johnson,
Neurology
(1995) 1:65-70). Copolymer-1 therapy is presently limited to its daily subcutaneous administration.
Currently, all specifically approved treatments of multiple sclerosis involve self-injection of the active substance. Frequently observed injection-site problems include irritation, hypersensitivity, inflammation, pain and even necrosis (in the case of at least one interferon &bgr; 1-B treatment) and a low level of patient compliance. Therefore, an alternative method of administration is desirable.
EP Patent 359,783 discloses the treatment of autoimmune diseases by oral administration of autoantigens. It discloses the oral administration of MBP for treatment of multiple sclerosis. Oral administration of an autoantigen has been termed “oral tolerance.”
PCT International Application Publication Nos. WO 91/12816, WO 91108760, and WO 92/06704 all disclose the treatment of other autoimmune diseases using the “oral tolerance” method with a variety of autoantigens. However, none of these references disclose the treatment of multiple sclerosis by the oral administration of non-autoantigen copolymer-1. The contents of all these patents and all literature references referred to above are hereby incorporated by reference in their entirety.
It is, therefore, an object of the present invention to provide a method for treating multiple sclerosis by oral administration of copolymer-1 through ingestion or inhalation.
REFERENCES:
patent: 3849550 (1974-11-01), Teitelbaum et al.
patent: 4339431 (1982-07-01), Gaffar
patent: 5204099 (1993-04-01), Barbier et al.
patent: 5627206 (1997-05-01), Hupe et al.
patent: 5719296 (1998-02-01), Action, III et al.
patent: 5981581 (1999-11-01), Konkino et al.
patent: 383620A2 (1990-08-01), None
patent: WO9533475 (1995-12-01), None
Chem. abstr., vol. 125, No. 23, Dec. 2, 1996 (Columbus OH, USA), p. 1, column 2, the abstract No. 291993b, Johnson, K.P., et al., ‘Management of Relapsing/Remitting Multiple Sclerosis with Copolymer 1 (Copaxone).’ Mult. Scler. 1996, 1(6), 325-326 (Eng.), see entire document.
Teitelbaum et al., “Suppression of Experimental Allergic Encephalomyelitis by a Synthetic Polypeptide”,Israel J. Med. Sci.,1971, 7, 630-631 (Abstract) (Exhibit 6).
Teitelbaum et al., “Suppression of Experimental Allergic Encephalomyelitis by a Synthetic Polypeptide”,Eur. J. Immunol.,1971, 1, 242-248 (Exhibit 7).
Arnon et al., “Suppression of Experimental Allergic Encephalomyelitis by a Synthetic Copolymer Immunological Cross Reactive with Basic Encephalitogen”,Israel J. Med. Sci.,1972, 8, 1759-1760 (Exhibit 8).
Teitelbaum et al., “Protection Against Experimental Allergic Encephalomyelitis”,Nature,1972, 240, 564-566 (Exhibit 9).
Webb et al., “Further Studies on the Suppression of Experimental Allergic Encephalomyelitis by Synthetic Copolymer”,Israel J. Med. Sci.,1972, 8, 656-657 (Exhibit 10).
Teitelbaum et al., “Suppression of Experimental Allergic Encephalomyelitis with Basic Polymers”,Eur. J. Immunol.,1973, 3, 273-279 (Exhibit 11).
Webb et al., “In Vivo and in Vitro Immunological Cross-reactions between Basic Encephalitogen and Synthetic Basic Polypeptides Capable of Suppressing Experimental Allergic Encephalomyelitis”,Eur. J. Immunol,1973, 3, 279-286 (Exhibit 12).
Teitelbaum et al., “Dose-response Studies on Experimental Allergic Encephalomyelitis Suppression by Cop-1”,Israel. J. Med. Sci.,1974, 10(9), 1172-1173 (Exhibit 13).
Teitelbaum et al., “Suppression of Experimental Allergic Encephalomyelitis in Rhesus Monkeys by a Synthetic Basic Copolymer”,Clin. Immunol. Immunopath.,1974, 3, 256-262 (Exhibit 14).
Webb et al., “Suppression of Experimental Allergic Encephalomyelitis in Rhesus Monkeys by a Synthetic Basic Copolymer”,Isr. J. Med. Sci.,1975, 11, 1388 (Abstract) (Exhibit 15).
Webb et al., “Molecular Requirements Involved in Suppression of EAE by Synthetic Basic Copolymers of Amino Acids”,Immunochem.,1976, 13, 333-337 (Exhibit 16).
Abramsky et al., “Effect of a Synthetic Polypeptide (Cop-1) on Patients with Multiple Sclerosis and with Acute Disseminated Encephalomyelitis”,J. Neurol. Sci.,1977, 31, 433-438 (Exhibit 17).
Teitelbaum et al., “Suppression of Experimental Allergic Encephalomyelitis in Baboons by Cop 1”,Israel J. Med. Sci.,1977, 13, 1038 (Abstract) (Exhibit 18).
Arnon et al., “Suppression of EAE in Baboons by a Synthetic Polymer of Amino Acids”,Neurol.,1978, 28, 336 (Abstract) (Exhibit 19).
Sela et al., “Experimental Allergic Encephalomyelitis” inMenarini Series on Immunopathology,vol. 1, First Symposium of Organ Specific Autoimmunity, Cremona, Italy, Jun., 1977, (Miescher P.A. ed., Schwabe Co., Basel, 1978), 9-21 (Exhibit 20).
Alvord et al., “Myelin Basic Protein Treatment of Experimental Allergic Encephalomyelitis in Monkeys”,Ann. Neurol.,1979, 6, 469-473 (Exhibit 21).
Keith et al., “The Effect of Cop 1, a Synthetic Polypeptide, on Chronic Relapsing Experimental Allergic Encephalomyelitis in Guinea Pigs”J. Neurol. Sci.,1979, 42, 267-274 (Exhibit 22).
Lando et al., “Effect of Cyclophosphamide on Suppressor Cell Activity in Mice Unresponsive to EAE”,J. Immunol.,1979, 123, 2156-2160. (Abstract) (Exhibit 23).
Lando et al., “Experimental Allergic Encephalomyelitis in Mice—Suppression and Prevention with Cop-1”,Israel J. Med. Sci.,1979, 15, 868-869 (Abstract) (Exhibit 24).
Teitelbaum et al., “Blocking of Sensitization to Encephalitogenic Basic Protein in Vitro by Synthetic Basic Copolymer (Cop 1)”inCell Biology and Immunology of Leukocyte Function(Academic Press, New York, 1979) 681-685 (Exhibit 25).
Teitelbaum, “Suppression of Experimental Allergic Encephalomyelitis with a Synthetic Copolymer—Relevance to Multiple Sclerosis”, inHumoral Immunity in Neurological Diseases(Karcher D., Lowenthal A. & Strosberg A.D., eds., Plenum Publishing Corp., 1979) 609-613 (Exhibit 26).
Arnon et al., “Desensitization of Experimental Allergic Encephalomyelitis with Synthetic Peptide Analogues” inThe Suppression of Experimental Allergic Encephalomyelitis and Multiple Sclerosis(Academic Press, New York, 1980) 105-107 (Exhibit 27).
Arnon, “A Synthetic Copolymer of Amino Acids in a Clinical Trial for MS Therapy” inProgress in Multiple Sclerosis Research(Bauer, Ritter, eds., Springer Verlag, New York, 1980) 416-418 (Exhibit 28).
Bornstein et al., “Treatment of Multiple S
Arnon Ruth
Gilbert Adrian
Linenberg Milka
Riven-Kreitmann Rivka
Sela Michael
Cooper & Dunham LLP
Reamer James H.
White John P.
Yeda Research and Development Co. Ltd.
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