Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Having -c- – wherein x is chalcogen – bonded directly to...
Reexamination Certificate
2003-10-09
2009-10-20
Marschel, Ardin (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
07605167
ABSTRACT:
This invention concerns the use of cyclopamine, a naturally occurring steroidal alkaloid known for over thirty years, for the treatment of psoriasis and achievement of rapid clearance of the psoriatic skin lesions together with the reversion of the histopathological signs of disease to normalcy with no detectable side effects. The cyclopamine-induced clearance of psoriatic lesions from the skin of patients is associated with the causation of cellular differentiation in lesional epidermis and with the rapid disappearance of CD4(+) lymphocytes and other inflammatory cells from lesional skin. Therapeutic compositions comprising of cyclopamine and a corticosteroid and/or the pre-treatment of lesions with a corticosteroid provide significantly further increased therapeutic effectiveness over the use of cyclopamine alone or a corticosteroid alone.
REFERENCES:
patent: 4370322 (1983-01-01), Busse et al.
patent: 6291516 (2001-09-01), Dudek et al.
patent: 6432970 (2002-08-01), Beachy et al.
patent: 6927205 (2005-08-01), Patt
patent: 6951839 (2005-10-01), Crompton
patent: 2002/0165221 (2002-11-01), Baxter et al.
patent: 2004/0072914 (2004-04-01), Tas et al.
patent: WO 98/35020 (1998-08-01), None
patent: 99/52534 (1999-10-01), None
patent: 00/41545 (2000-07-01), None
patent: 00/74706 (2000-12-01), None
patent: WO 00/74706 (2000-12-01), None
patent: 01/27135 (2001-04-01), None
patent: 01/40438 (2001-06-01), None
patent: WO 01/98344 (2001-12-01), None
patent: WO 02/07702 (2002-01-01), None
patent: WO 02/30462 (2002-04-01), None
patent: WO 02/080952 (2002-10-01), None
Tas S et al, Induction of the differentiation and apoptosis of tumor cells in vivo with efficiency and selectivity.European Journal of Dermatology2004; 14:96-102.
Riddle RD et al, Sonic hedgehog mediates polarizing activity of the ZPA.Cell1993; 75:1401-1416.
Basler K et al, Compartment boundaries and the control of Drosophila limb pattern by hedgehog protein.Nature1994; 368: 208-214.
Kojima T et al, Induction of a mirror-image duplication of anterior wing structures by localized hedgehog expression in the anterior compartment ofDrosophila melanogasterwing imaginal discs.Gene1994; 148:211-217.
Heberlein U et al, Growth and differentiation in the Drosophila eye coordinated by hedgehog.Nature1995; 373: 709-711.
Lepage T et al, Signal transduction by cAMP-dependent protein kinase A in Drosophila limb patterning.Nature1995; 373: 711-715.
Oro AE et al, Basal cell carcinomas in mice overexpressing Sonic hedgehog.Science1997; 276: 817-821.
Bellusci S et al, Involvement of Sonic hedgehog (Shh) in mouse embryonic lung growth and morphogenesis.Development1997; 134: 53-63.
Litingtung Y et al, Sonic hedgehog is essential to foregut development.Nature Genetics1998; 20: 58-61.
Orentas DM et al, Sonic hedgehog signaling is required during the appearance of spinal cord oligodendrocyte precursors.Development1999; 126:2419-2429.
Furumichi T et al, Adenosine 3′:5′-cyclic monophosphate inhibits in vitro angiogenesis induced by endothelial cell growth factor.Japanese Heart Journal1992; 33: 373-382.
Tsopanoglou NE et al, Opposing effects on modulation of angiogenesis by protein kinase C and cAMP-mediated pathways.Journal of Vascular Research1994; 31: 195-204.
Johnson RL et al, Patched overexpression alters wing disc size and pattern: transcriptional and post-transcriptional effects on hedgehog targets.Development1995; 121: 4161-4170.
deCelis JF et al, Ventral veinless, the gene encoding the Cf1 a transcription factor, links positional information and cell differentiation during embryonic and imaginal development inDrosophila melanogaster. Development1995; 121: 3405-3416.
Roberts DR et al, Sonic hedgehog is an endodermal signal inducing Bmp-4 and Hox genes during induction and regionalization of the chick hindgut.Development1995; 121: 3163-3174.
Winnier G et al, Bone morphogenetic protein-4 is required for mesoderm formation and patterning in the mouse.Genes&Development1995; 9: 2105-2116.
Bavik C et al, Developmental abnormalities in cultured mouse embryos deprived of retinoic acid by inhibition of yolk sac retinol binding protein synthesis.Proceedings of the National Academy of the Sciences o f USA1996; 93: 3110-3114.
Dickson MC et al, Defective haematopoiesis and vasculogenesis in transforming growth factor-beta 1 knock out mice.Development1995; 121: 1845-1854.
D'Angelo G et al, cAMP-dependent protein kinase inhibits the mitogenic action of vascular endothelial growth factor and fibroblast growth factor in capillary endothelial cells by blocking Raf activation.Journal of Cell Biochemistry1997; 6767: 353-366.
Farrington SM et al, Winged-Helix, Hedgehog and Bmp genes are differentially expressed in distinct cell layers of the murine yolk sac.Mechanisms of Development1997; 62: 197-211.
St Amand TR et al, Cloning and expression pattern of chicken Pitx2: A new component in the Shh signaling pathway controlling embryonic heart looping.Biochemical and Biophysical Research Communications1998; 247: 100-105.
Pepicelli CV et al, Sonic hedgehog regulates branching morphogenesis in the mammalian lung.Current Biolog1998; 8: 1083-1086.
Grabel L et al, Using EC and ES cell culture to study early development: recent observations on Indian hedgehog and Bmps.International Journal of Developmental Biology1998; 42: 917-925.
St Jacques B et al, Indian hedgehog signaling regulates proliferation and differentiation of chondrocytes and is essential for bone formation.Genes&Development1999; 13: 2072-2086.
Brown LA et al, Insights into early vasculogenesis revealed by expression of the ETS-domain transcription factor Fli-1 in wild type and mutant zebrafish embryos.Mechanisms of Development2000, 90: 237-252.
Maye P et al, Indian hedgehog signaling in extraembryonic endoderm and ectoderm differentiation in ES embryoid bodies.Mechanisms of Development2000; 94: 117-132.
Dyer M et al, Indian hedgehog activities hematopoiesis and vasculogenesis and can respecify prospective neuroectodermal cell fate in the mouse embryo.Development2001; 128: 1717-1730.
Braybrooke JP et al, A phase II study of razoxane, an antiangiogenic topoisomerase II inhibitor, in renal cell cancer with assessment of potential surrogate markers of angiogenesis.Clinical Cancer Research2000; 6: 4697-4704.
Dunn MK et al, Cyclopamine, A Steroidal Alkaloid Disrupts Development of Neural Crest Cells in Xenopus.Developmental Dynamics1995; 202: 255-270.
Tas S et al, Rapid clearance of psoriatic skin lesions induced by topical cyclopamine.Dermatology2004; 209: 126-131.
Sauder et al, Neovastat (AE-941), an inhibitor of angiogenesis: Randomized phase I/II clinical trial results in patients with plaque psoriasis.J Am Acad Dermatol; vol. 47, No. 4, 2002; 535-541.
Taipale et al in “Nature” Aug. 31, 2005, GB.
Lebwohl Mark et al in “International Journal of dermatology” May 2002, USA.
“The Merk manual” in 99, USA (1999).
Goodman & Gilman'S, The Pharmacological Basis of Therapeutics, Ninth Edition, (1996), Calabresi et al., Section X, Chemotherapy of Neoplastic Discases, pp. 1225-1229.
“Transient activation of B-catenin signaling in adult mouse epidermis is sufficient to induce new hair follicles but continuous activation is required to maintain hair follicle tumours,” Celso at al., Development 131, 1787- 1799, (2001).
Levine, Edward M. et al., Sonic Hedgehog Promotes Rod Photoreceptor Differentiation in Mammalian Retinal Cells In Vitro,The Journal of Neuroscience, Aug. 15, 1997, 17(16):6277-6288.
Kim, Seung K. et al., “Pancreas development is promoted by cyclopamine, a Hedgehog signaling inhibitor,”Proc. Natl. Acad. Sci. USA, vol. 95, pp. 13036-13041, Oct. 1998, Developmental Biology.
Incardona, John P. et al., “The teratogenic Veratrum alkaloid cyclopamine inhibits Sonic hedgehog signal transduction,”Development 125, pp. 3553-3562 (1998), Printed in Great Britain © The Company of Biologists Limited 1998.
Cooper, Michael K., “Teratogen-Mediated Inhibition of Target Tissue Responses to Shh Signaling,ȁ
Avci Oktay
Tas Sinan
Anderson James D
Marschel Ardin
Tas Sinan
LandOfFree
Use of cyclopamine in the treatment of psoriasis 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 cyclopamine in the treatment of psoriasis, we encourage you to share that experience with our LandOfFree.com community. Your opinion is very important and Use of cyclopamine in the treatment of psoriasis will most certainly appreciate the feedback.
Profile ID: LFUS-PAI-O-4091271