Claims for Patent: 9,381,228

Summary for Patent: 9,381,228

Title:	FKBP-L and uses thereof
Abstract:	Disclosed are methods and compositions that employ FKBP-L polypeptides for modulating angiogenesis and/or tumor metastasis. The FKBP-L polypeptides may be used for the treatment of disorders mediated by angiogenesis such as cancer.
Inventor(s):	Robson; Tracy (Northern Ireland, GB), Valentine; Andrea (Craigavon, GB), O\'Rourke; Martin Gerard (Craigavon, GB), Hirst; David (Northern Ireland, GB)
Assignee:	ALMAC DISCOVERY LIMITED (GB)
Application Number:	12/303,343
Patent Claims:	1. A method of inhibiting angiogenesis in a subject in need thereof comprising administering to the subject a therapeutically effective amount of a composition comprising an isolated polypeptide and a pharmaceutical carrier, wherein the subject in need thereof has a disorder mediated by angiogenesis, and wherein the isolated polypeptide is selected from the group consisting of a polypeptide whose sequence consists of SEQ ID NO: 10 and a polypeptide whose sequence consists of SEQ ID NO: 14. 2. The method of claim 1, wherein the disorder mediated by angiogenesis is an inflammatory disorder. 3. The method of claim 1, wherein the disorder mediated by angiogenesis is an ocular disorder. 4. The method of claim 1, wherein the disorder mediated by angiogenesis is cancer. 5. The method of claim 4, wherein the cancer is chosen from colorectal carcinoma, gastric carcinoma, signet ring type, esophageal carcinoma, intestinal type, mucinous type, pancreatic carcinoma, lung carcinoma, breast carcinoma, renal carcinoma, bladder carcinoma, prostate carcinoma, testicular carcinoma, ovarian carcinoma, endometrial carcinoma, thyroid carcinoma, liver carcinoma, larynx carcinoma, mesothelioma, neuroendocrine carcinomas, neuroectodermal tumors, melanoma, gliomas, neuroblastomas, sarcomas, leiomyosarcoma, fibrosarcoma, liposarcoma, chondrosarcoma, leukemia, and lymphoma metastasis. 6. The method of claim 4, wherein administration of the composition further results in at least one anti-tumor effect chosen from reduction of tumor cell migration and reduction of metastasis in the subject. 7. The method of claim 4, wherein administration of the composition further results in at least one anti-tumor effect chosen from reduction of tumor cell growth and reduction of tumor cell proliferation in the subject. 8. The method of claim 1, wherein the composition is administered in combination with at least one further treatment chosen from a chemotherapeutic agent, a chemopreventative agent, radiotherapy, and a combination of the same. 9. The method of claim 8, wherein the at least one chemotherapeutic agent or chemopreventative agent comprises at least one agent chosen from endostatin, angiostatin, VEGF inhibitors, cytotoxic agents, alkaloids, antimetabolites, cancer growth inhibitors, gene therapy therapeutics, cancer vaccines, interferons, Aldesleukin, monoclonal antibodies, radiotherapy, and hormonal therapy. 10. The method of claim 9, wherein the cytotoxic agents are chosen from adriamycin, daunomycin, cis-platinum, etoposide, taxol, and taxotere. 11. The method of claim 9, wherein the alkaloids are chosen from vincristine and farnesyl transferase inhibitors. 12. The method of claim 9, wherein the cancer growth inhibitors are chosen from bortezomib, erlotinib, gefitinib, imatinib, and sorafenib. 13. The method of claim 9, wherein the hormonal therapy is chosen from anastrozole, bicalutamide, buserelin, cyproterone, diethylstilbestrol, exemestane, flutamide, fulvestrant, goserelin, letrozole, leuprorelin, medroxyprogesterone, megestrol acetate, tamoxifen, toremifene, and triptorelin. 14. The method of claim 9, wherein the monocolonal antibodies are chosen from .sup.90Y-ibritumomab tiuxetan, alemtuzumab, bevacizumab, cetuximab, gemtuzumab, iodine 131 (.sup.1311) tositumomab, panitumumab, rituximab, and trastuzumab. 15. The method of claim 1, wherein the composition is administered in combination with supportive therapy and wherein the supportive therapy is chosen from bisphosphonates, blood transfusions, erythropoietin, haematopoietic growth factors, plasma exchange, platelet transfusions, steroids, hyperbaric oxygen therapy, hyperthermia treatment, and photodynamic therapy. 16. The method of claim 8, wherein the at least one chemotherapeutic agent or chemopreventative agent comprises at least one agent chosen from chemotherapy drugs and antiangiogenics. 17. The method of claim 8, wherein the at least one chemotherapeutic agent or chemopreventative agent is chosen from amsacrine, bleomycin, busulfan, capecitabine, carboplatin, carmustine, chlorambucil, cisplatin, cladribine, crisantaspase, cycolophosphamide, cytarabine, dacarbazine, dactinomycine, daunorubicin, docetaxel, doxorubicin, epirubicin, etoposide, fludarabine, fluorouracil, gemcitabine, gliadel implants, hydroxycarbamide, idarubicin, ifosfamide, irinotecan, leucovorin, liposomal doxorubicin, liposomal daunorubicin, lomustine, melphalan, mercaptopurine, mesna, methotrexate, mitomycin, mitoxantrone, oxaliplatin, paclitaxel, pemetrexed, pentostatin, procarbazine, raltitrexed, streptozocin, tegafur-uracil, temozolomide, teniposide, thiotepa, tioguanine, topotecan, treosulfan, vinblastine, vincristine, vindesine, and vinorelbine. 18. The method of claim 1, wherein the polypeptide is linked to a polymer and wherein the polymer is chosen from dextrans, polyvinyl pyrrolidones, and polyethylene glycol. 19. The method of claim 18, wherein the polymer is polyethylene glycol. 20. The method of claim 1, wherein the polypeptide is linked to a molecule chosen from carbohydrates, monosaccharides, oligosaccharides, polysaccharides, glycolipids, heterocyclic compounds, nucleosides, and nucleotides. 21. The method of claim 1, wherein the polypeptide is a modified polypeptide, and wherein the modified polypeptide is chosen from phosphopeptides, cyclic peptides, peptides containing D-amino acids, and peptides containing radiolabels. 22. The method of claim 21, wherein the modified polypeptide is chosen from peptides containing D-amino acids and peptides containing radiolabels. 23. The method of claim 1, wherein the polypeptide is modified by the addition of biotin. 24. The method of claim 1, wherein the polypeptide is modified by the addition of a moiety to facilitate crosslinking, wherein the moiety is chosen from benzophenone, maleimide, and activated esters. 25. The method of claim 1, wherein the polypeptide is modified by the addition of a moiety to facilitate crosslinking and wherein the moiety is chosen from heterobifunctional cross-linking agents containing maleimide and an activated ester. 26. The method of claim 1, wherein the composition is a sustained release formulation or is in a sustained release carrier. 27. The method of claim 1, wherein the composition is administered in microspheres or liposomes. 28. The method of claim 26, wherein the sustained release carrier comprises one or more of polylactides copolymers of L-glutamic acid and gamma ethyl-L-glutamate, poly (2-hydroxyethyl-methacrylate), or ethylene vinyl acetate. 29. The method of claim 1, wherein the polypeptide is administered at a dosage ranging from 0.00003 mg/kg/day to 30 mg/kg/day. 30. The method of claim 1, wherein the peptide is administered at a dosage ranging from 0.003 mg/kg/ day to 3 mg/kg/day. 31. The method of claim 1, wherein the peptide is administered at a dosage ranging from 0.03 mg/kg/day to 0.3 mg/kg/day. 32. The method of claim 1, wherein the composition is administered orally, parenterally, topically, by inhalation, intranasally, or rectally. 33. The method of claim 1, wherein the composition is administered intravenously, intramuscularly, intracisternally, intradermally, intrathecally, epidurally, or by infusion. 34. The method of claim 1, wherein the composition comprises at least one additive chosen from pharmaceutically acceptable excipients, carriers, preservatives, buffers, stabilizers, antioxidants, and other additives. 35. The method of claim 1, wherein the composition is in a form chosen from a tablet, capsule, powder, and liquid. 36. The method of claim 35, wherein the liquid comprises at least one additive chosen from liquid carriers, petroleum, animal oils, vegetable oils, mineral oils, synthetic oils, physiological saline solutions, saccharide solutions, and glycols. 37. The method of claim 1, wherein the composition is administered in combination with bevacizumab. 38. The method of claim 1, wherein the composition is administered in combination with sorafinib. 39. The method of claim 5, wherein the cancer is ovarian cancer. 40. The method of claim 5, wherein the cancer is renal cancer. 41. The method of claim 5, wherein the cancer is lung cancer. 42. The method of claim 5, wherein the cancer is a glioma. 43. The method of claim 39, wherein the composition is administered in combination with at least one further treatment chosen from a chemotherapeutic agent, a chemopreventative agent, radiotherapy, and a combination of the same. 44. The method of claim 43, wherein the at least one further treatment is bevacizumab. 45. The method of claim 40, wherein the composition is administered in combination with sorafenib.

Details for Patent 9,381,228

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Clinigen, Inc.	PROLEUKIN	aldesleukin	For Injection	103293	05/05/1992		2026-06-09
Genentech, Inc.	RITUXAN	rituximab	Injection	103705	11/26/1997		2026-06-09
Idec Pharmaceuticals Corp.	RITUXAN	rituximab	Injection	103737	02/19/2002		2026-06-09
Genentech, Inc.	HERCEPTIN	trastuzumab	For Injection	103792	09/25/1998		2026-06-09
Genentech, Inc.	HERCEPTIN	trastuzumab	For Injection	103792	02/10/2017		2026-06-09