Claims for Patent: 9,486,522

Summary for Patent: 9,486,522

Title:	Compositions including triciribine and trastuzumab and methods of use thereof
Abstract:	This application relates to combination therapies including triciribine and related compounds and trastuzumab or a salt thereof and compositions with reduced toxicity for the treatment and prevention of tumors, cancer, and other disorders associated with abnormal cell proliferation.
Inventor(s):	Cheng; Jin Q. (Tampa, FL), Sebti; Said M. (Tampa, FL)
Assignee:	University of South Florida (Tampa, FL)
Application Number:	14/881,777
Patent Claims:	1. A method of treating a tumor or cancer that overexpressed AKT in a mammal comprising administering to the mammal an effective amount of a composition comprising: (i) a compound of formula I: ##STR00011## wherein each R.sub.2', R.sub.3' and R.sub.5' are independently hydrogen, optionally substituted phosphate or phosphonate; acyl; alkyl; amide, sulfonate ester including alkyl or arylalkyl; sulfonyl, methanesulfonyl, benzylsulfonyl; optionally substituted arylsulfonyl; a lipid, a phospholipid; an amino acid; a carbohydrate; a peptide; or cholesterol; or other pharmaceutically acceptable leaving group that, in vivo, provides a compound wherein R.sub.2', R.sub.3' and R.sub.5' is independently H or mono-, di- or tri-phosphate; wherein R.sup.x and R.sup.y are independently hydrogen, optionally substituted phosphate; acyl; amide, alkyl; aromatic, polyoxyalkylene such as polyethyleneglycol, optionally substituted arylsulfonyl; a lipid, including a phospholipid; an amino acid; a carbohydrate; a peptide; or cholesterol; or other pharmaceutically acceptable leaving group; R.sub.1 and R.sub.2 each are independently H, optionally substituted straight chained, branched or cyclic alkyl, alkenyl, or alkynyl, CO-alkyl, CO-alkenyl, CO-alkynyl, CO-aryl or heteroaryl, CO-alkoxyalkyl, CO-aryloxyalkyl, CO-substituted aryl, sulfonyl, alkylsulfonyl, arylsulfonyl, aralkylsulfonyl; and (ii) trastuzumab or a salt thereof; wherein the compound of formula I is administered to said mammal in an amount of at least 10 mg/m.sup.2. 2. The method of claim 1, wherein a compound of formula I and trastuzumab or a salt thereof are administered simultaneously. 3. The method of claim 1, wherein a compound of formula I is administered followed by the administration of trastuzumab or a salt thereof. 4. The method of claim 1, wherein the trastuzumab or a salt thereof is administered followed by the administration of a compound of formula I. 5. The method of claim 1, wherein the compound of formula I is administered one time per week for three weeks followed by a one-week period wherein the compound is not administered. 6. The method of claim 1, wherein the trastuzumab or a salt thereof is administered one time per week for three weeks followed by a one-week period wherein the compound is not administered. 7. The method of claim 6, wherein the dosing schedule is repeated at least twice. 8. The method of claim 6, wherein the dosing schedule is repeated at least 4 times. 9. The method of claim 1, wherein the tumor treated is breast, pancreatic, ovarian and colorectal tumors. 10. The method of claim 1, wherein at least 100 mg of trastuzumab or a salt thereof is administered. 11. The method of claim 1, wherein at least 200 mg of trastuzumab or a salt thereof is administered. 12. The method of claim 1, wherein at least 400 mg of trastuzumab or a salt thereof is administered.

Details for Patent 9,486,522

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Genentech, Inc.	HERCEPTIN	trastuzumab	For Injection	103792	09/25/1998		2024-03-29
Genentech, Inc.	HERCEPTIN	trastuzumab	For Injection	103792	02/10/2017		2024-03-29
Genentech, Inc.	HERCEPTIN HYLECTA	trastuzumab and hyaluronidase-oysk	Injection	761106	02/28/2019		2024-03-29