Claims for Patent: 7,329,642

Summary for Patent: 7,329,642

Title:	.beta.-2-glycoprotein is an inhibitor of angiogenesis
Abstract:	The present disclosure provides a method of inhibiting angiogenesis within a tissue of interest by providing either intact or nicked .beta.2-Glycoprotein 1 (.beta.2GP1) to cells associated with the tissue. The presence of .beta.2GP1 inhibits angiogenesis within the tissue, in part by preventing neovascularization into the tissue. The disclosure also provides a method for treating tumors by providing .beta.2GP1 to the tumor.
Inventor(s):	Schroit; Alan Jay (Bellaire, TX), Balasubramanian; Krishnakumar (Pearland, TX), McCarty; Marya (Houston, TX)
Assignee:	Board of Regents, University of Texas System (Austin, TX)
Application Number:	10/406,158
Patent Claims:	1. A method of inhibiting angiogenesis and/or angioectasia within a tissue comprising administering an effective amount of N-.beta.2GP1 to cells associated with the tissue, wherein the amount is sufficient to inhibit angiogenesis and/or angioectasia within the tissue. 2. The method of claim 1, wherein angiogenesis is inhibited within the tissue. 3. The method of claim 1, wherein angioectasia is inhibited within the tissue. 4. The method of claim 1, wherein the N-.beta.2GP1 is substantially pure N-.beta.2GP1. 5. The method of claim 1, wherein the N-.beta.2GP1 is administered to the cells by exposing a composition comprising N-.beta.2GP1 polypeptide to the cells. 6. The method of claim 1, wherein the cells associated with the tissue are endothelial cells. 7. The method of claim 6, wherein the endothelial cells are selected from the group consisting of vascular endothelial cells, pulmonary endothelial cells, heart endothelial cells, gastrointestinal endothelial cells, brain endothelial cells, lymphatic endothelial cells, genital-urinary endothelial cells, skin endothelial cells, bone endothelial cells, muscle endothelial cells, breast endothelial cells, retinal endothelial cells, endocrine endothelial cells, central nervous system endothelial cells, hepatic endothelial cells, and umbilical cord endothelial cells. 8. The method of claim 1, wherein the tissue is a tumor. 9. The method of claim 8, further comprising inhibiting neovascularization into the tumor. 10. The method of claim 1, further comprising administering an antiangiogenic agent to the cells in conjunction with N-.beta.2GP1. 11. The method of claim 10, wherein the antiangiogenic agent is selected from the group consisting of angiostatin, endostatin, trastuzumab, thrombospondin, IFN-.alpha., TIMP-1, PF4, fumagiulin, and mixtures thereof. 12. A method of inhibiting angiogenesis and/or angioectasia within a neoplasm comprising administering an effective amount of N-.beta.2GP1 to the neoplasm, wherein the amount is sufficient to inhibit angiogenesis and/or angioectasia within the neoplasm. 13. The method of claim 12, wherein angiogenesis is inhibited within the neoplasm. 14. The method of claim 12, wherein angioectasia is inhibited within the neoplasm. 15. The method of claim 12, wherein the N-.beta.2GP1 is substantially pure N-.beta.2GP1. 16. The method of claim 12, further comprising inhibiting metastasis of the neoplasm. 17. The method of claim 12, wherein the neoplasm is a tumor. 18. The method of claim 17, further comprising inhibiting neovascularization into the tumor. 19. The method of claim 12, further comprising administering an antiangiogenic agent to the neoplasm in conjunction with N-.beta.2GP1. 20. The method of claim 19, wherein the antiangiogenic agent is selected from the group consisting of angiostatin, endostatin, trastuzumab, thrombospondin, IFN-.alpha., TIMP-1, PF4, and fumagillin. 21. The method of claim 12, further comprising administering a therapeutic agent useful in the treatment of the neoplasm in conjunction with N-.beta.2GP1. 22. The method of claim 21, wherein the therapeutic agent is selected from the group consisting of cisplatin, doxorubicin, paclitaxel, vincristine, and vinblastin. 23. A method of inhibiting angiogenesis and/or angioectasia at a tumor site in a subject comprising administering an effective amount of N-.beta.2GP1 to the subject, wherein the amount is sufficient to inhibit angiogenesis and/or angioectasia at the tumor site. 24. The method of claim 23, wherein angiogenesis is inhibited at the tumor site. 25. The method of claim 23, wherein angioectasia is inhibited at the tumor site. 26. The method of claim 23, wherein the subject is human. 27. The method of claim 23, wherein the N-.beta.2GP1 is substantially pure N-.beta.2GP1. 28. The method of claim 23, wherein the route of administration to the subject is oral, intravenous, intramuscular, intrathecal, intradermal, intraperitoneal, subcutaneous, intrapleural, intrauterine, rectal, vaginal, topical, intratumor, transdermal, or transmucosal. 29. The method of claim 23, wherein the tumor site is melanoma tissue, and the effective amount of N-.beta.2GP1 is from about 50 to about 200 mg of N-.beta.2GP1 administered topically. 30. The method of claim 23, wherein the tumor site is fibrosarcoma tissue, and the effective amount of N-.beta.2GP1 is from about 200 to about 300 mg of N-.beta.2GP1 administered intravenously. 31. The method of claim 23, wherein the tumor site is breast cancer tissue, and the effective amount of N-.beta.2GP1 is from about 250 to about 400 mg of N-.beta.2GP1 administered by direct injection. 32. The method of claim 23, wherein the tumor site is prostate cancer tissue, and the effective amount of N-.beta.2GP1 is from about 150 to about 300 mg of N-.beta.2GP1 administered by direct injection. 33. The method of claim 23, wherein the tumor site is colon cancer tissue, and the effective amount of N-.beta.2GP1 is from about 50 to about 250 mg of N-.beta.2GP1 administered intravenously. 34. A pharmaceutical composition comprising N-.beta.2GP1 and a second antiangiogenic agent useful for the inhibition of angiogenesis and/or angioectasia. 35. The composition of claim 34, wherein the N-.beta.2GP1 is substantially pure N-.beta.2GP1. 36. The composition of claim 34, wherein the antiangiogenic agent is selected from the group consisting of angiostatin, endostatin, trastuzumab, thrombospondin, IFN-.alpha., TIMP-1, PF4, and fumagillin. 37. A pharmaceutical composition comprising N-.beta.2GP1 and a second therapeutic agent, wherein the second therapeutic agent is useful for the treatment of a neoplasm. 38. The composition of claim 37, wherein the N-.beta.2GP1 is substantially pure N-.beta.2GP1. 39. The composition of claim 37, wherein the therapeutic agent is selected from the group consisting of cisplatin, doxorubicin, paclitaxel, vincristine, and vinblastin. 40. A method of inhibiting endothelial cell proliferation comprising administering an effective amount of N-.beta.2GP1 to the cells, wherein the amount is sufficient to inhibit endothelial cell proliferation. 41. The method of claim 40, wherein the N-.beta.2GP1 is substantially pure N-.beta.2GP1. 42. The method of claim 40, further comprising inhibiting endothelial cell migration. 43. The method of claim 40, further comprising inhibiting endothelial cell differentiation. 44. The method of claim 43, wherein the endothelial cells are inhibited from differentiating into tubular capillary structures.

Details for Patent 7,329,642

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Genentech, Inc.	HERCEPTIN	trastuzumab	For Injection	103792	09/25/1998		2022-05-17
Genentech, Inc.	HERCEPTIN	trastuzumab	For Injection	103792	02/10/2017		2022-05-17
Genentech, Inc.	HERCEPTIN HYLECTA	trastuzumab and hyaluronidase-oysk	Injection	761106	02/28/2019		2022-05-17