Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Having -c- – wherein x is chalcogen – bonded directly to...
Reexamination Certificate
2000-01-28
2001-12-25
Henley, III, Raymond (Department: 1614)
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
Having -c-, wherein x is chalcogen, bonded directly to...
Reexamination Certificate
active
06333347
ABSTRACT:
TECHNICAL FIELD
The present invention relates generally to compositions, methods and devices for administering intra-pericardially anti-microtubule agents.
BACKGROUND OF THE INVENTION
Restenosis is a form of chronic vascular injury leading to vessel wall thickening and loss of blood flow to the tissue supplied by the blood vessel. It occurs in response to vascular reconstructive procedures, including virtually any manipulation which attempts to relieve vessel obstructions, and is the major factor limiting the effectiveness of invasive treatments for vascular diseases. Restenosis has been a major challenge to cardiovascular research for the past 15 years. According to 1994 estimates (U.S. Heart and Stroke Foundation), over 60 million Americans have one or more forms of cardiovascular disease. These diseases claimed approximately 1 million lives in the same year (41% of all deaths in the United States) and are considered the leading cause of death and disability in the developed world.
The present invention provides compositions and methods for intrapericardially delivering an anti-microtubule agent so that disease within the pericardium, heart, or coronary vasculature (e.g., restenosis, primary stenosis, or, atherosclerosis) may be treated or prevented. These compositions and methods address the problems associated with the existing procedures, offer significant advantages when compared to existing procedures, and further provides other, related advantages.
SUMMARY OF THE INVENTION
Briefly stated, the present invention provides methods for administering intrapericardially an anti-microtubule agent, suitable for treating or preventing disease of the pericardium, heart, or, coronary vasculature. Representative examples of such agents include taxanes (e.g., paclitaxel and docetaxel), campothecin, eleutherobin, sarcodictyins, epothilones A and B, discodermolide, deuterium oxide (D
2
O), hexylene glycol (2-methyl-2,4-pentanediol), tubercidin (7-deazaadenosine), LY290181 (2-amino-4-(3-pyridyl)-4H-naphtho(1,2-b)pyran-3-cardonitrile), aluminum fluoride, ethylene glycol bis-(succinimidylsuccinate), glycine ethyl ester, nocodazole, cytochalasin B, colchicine, colcemid, podophyllotoxin, benomyl, oryzalin, majusculamide C, demecolcine, methyl-2-benzimidazolecarbamate (MBC), LY195448, subtilisin, 1069C85, steganacin, combretastatin, curacin, estradiol, 2-methoxyestradiol, flavanol, rotenone, griseofulvin, vinca alkaloids, including vinblastine and vincristine, maytansinoids and ansamitocins, rhizoxin, phomopsin A, ustiloxins, dolastatin 10, dolastatin 15, halichondrins and halistatins, spongistatins, cryptophycins, rhazinilam, betaine, taurine, isethionate, HO-221, adociasulfate-2, estramustine, monoclonal anti-idiotypic antibodies, microtubule assembly promoting protein (taxol-like protein, TALP), cell swelling induced by hypotonic (190 mosmol/L) conditions, insulin (100 nmol/L) or glutamine (10 mmol/L), dynein binding, gibberelin, XCHO1 (kinesin-like protein), lysophosphatidic acid, lithium ion, plant cell wall components (e.g., poly-L-lysine and extensin), glycerol buffers, Triton X-100 microtubule stabilizing buffer, microtubule associated proteins (e.g., MAP2, MAP4, tau, big tau, ensconsin, elongation factor-1-alpha (EF-1&agr;) and E-MAP-115), cellular entities (e.g., histone H1, myelin basic protein and kinetochores), endogenous microtubular structures (e.g., axonemal structures, plugs and GTP caps), stable tubule only polypeptide (e.g., STOP145 and STOP220) and tension from mitotic forces, as well as any analogues and derivatives of any of the above. Within other embodiments, the anti-microtubule agent is formulated to further comprise a polymer.
Within certain embodiments of the invention, the anti-microtubule agents may be formulated along with other compounds or compositions, such as, for example, an ointment, cream, lotion, gel, spray, foam, mousse, coating, wrap, paste, barrier, implant, microsphere, microparticle, film or the like. Within certain embodiments, the compound or composition may function as a carrier, which may be either polymeric, or non-polymeric. Representative examples of polymeric carriers include poly(ethylene-vinyl acetate), copolymers of lactic acid and glycolic acid, poly (caprolactone), poly (lactic acid), copolymers of poly (lactic acid) and poly (caprolactone), gelatin, hyaluronic acid, collagen matrices, celluloses and albumen. Representative examples of other suitable carriers include, but are not limited to ethanol; mixtures of ethanol and glycols (e.g., ethylene glycol or propylene glycol); mixtures of ethanol and isopropyl myristate or ethanol, isopropyl myristate and water (e.g., 55:5:40); mixtures of ethanol and eineol or D-limonene (with or without water); glycols (e.g., ethylene glycol or propylene glycol) and mixtures of glycols such as propylene glycol and water, phosphatidyl glycerol, dioleoylphosphatidyl glycerol, Transcutol®, or terpinolene; mixtures of isopropyl myristate and 1-hexyl-2-pyrrolidone, N-dodecyl-2-piperidinone or 1-hexyl-2-pyrrolidone.
These and other aspects of the present invention will become evident upon reference to the following detailed description and attached drawings. In addition, various references are set forth below which describe in more detail certain procedures, devices or compositions, and are therefore incorporated by reference in their entirety.
REFERENCES:
patent: 5283253 (1994-02-01), Holton et al.
patent: 5455039 (1995-10-01), Edelman et al.
patent: 5527532 (1996-06-01), Edelman et al.
patent: 5540928 (1996-07-01), Edelman et al.
patent: 5616608 (1997-04-01), Kinsella et al.
patent: 5626862 (1997-05-01), Brem et al.
patent: 5651986 (1997-07-01), Brem et al.
patent: 5667764 (1997-09-01), Kopia et al.
patent: 5716981 (1998-02-01), Hunter et al.
patent: 5733925 (1998-03-01), Kunz et al.
patent: 5766584 (1998-06-01), Edelman et al.
patent: 5770609 (1998-06-01), Grainger et al.
patent: 5811447 (1998-09-01), Kunz et al.
patent: 5886026 (1999-03-01), Hunter et al.
patent: 5916913 (1999-06-01), Joseph
patent: 5981568 (1999-11-01), Kunz et al.
patent: 5994341 (1999-11-01), Hunter et al.
patent: 6074659 (2000-06-01), Kunz et al.
patent: WO 93/11120 (1993-06-01), None
patent: WO 95/03795 (1995-02-01), None
patent: WO 96/25176 (1996-08-01), None
patent: WO 97/33552 (1997-09-01), None
patent: WO 98/43618 (1998-10-01), None
patent: WO 00/41687 (2000-07-01), None
Axel et al., “Paclitaxel inhibits arterial smooth muscle cell proliferation and migration in vitro and in viv using local drug delivery,”Circulation 96(2): 636-645, 1997.
Burt et al., “Development of copolymers of poly(D,L-lactide) and methoxypolyethylene glycol as micellar carriers of paclitaxel,”Colloids and Surfaces B: Biointerfaces 16(1-4): 161-171, 1999.
Komowski et al., “Slow-release taxol coated GRII™ stents reduce neointima formation on a porcine coronanry in-stent restenosis model,”Circulation 96(8): I-341, abstract #1900, 1997.
Kunert et al., “Paclitaxel inhibits development of restenosis following experimental balloon angioplasty in the rabbit carotid artery,”European Heart Journal XX(17): 368, 1996.
Zhang et al., “An investigation of the antitumour activity and biodistribution of polymeric micellar paclitaxel,”Cancer Chemother Pharmocol 40: 81-86, 1997.
Zhang et al., “Development of biodegradable polymeric paste formulations for taxol: an in vitro and in vivo study,”International Journal of Pharmaceutics 137(2): 199-208, 1996.
Bartoli et al., “In vitro and in vivo antitumoral activity of free and encapsulated taxol,”Journal of Microencapsulation 7(2): 191-197, 1990.
Walter et al., “Interstitial Taxol Delivered from a Biodegradable Polymer Implant angainst Experimental malignant Glimoa,”Cancer Research 51: 2207-2212, Apr. 15, 1994.
Sollott et al., “Taxol Inhibits Neointimal Smooth Muscle Cell Accumulation after Angioplasty in the Rat,”Journal of Clinical Investigation 95: 1869-1876, Apr. 1995.
Suh et al., “Regulation of smooth muscle cell proliferation using paclitaxel-loaded poly(ethylene oxide)-poly (lactide/glycolide) nanospheres,”J. Biomed
Hunter William L.
March Keith L.
Angiotech Pharmaceuticals & Advanced Research Tech
Henley III Raymond
Seed IP Law Group
LandOfFree
Intrapericardial delivery of anti-microtubule agents does not yet have a rating. At this time, there are no reviews or comments for this patent.
If you have personal experience with Intrapericardial delivery of anti-microtubule agents, we encourage you to share that experience with our LandOfFree.com community. Your opinion is very important and Intrapericardial delivery of anti-microtubule agents will most certainly appreciate the feedback.
Profile ID: LFUS-PAI-O-2584168