Claims for Patent: 9,844,581

Summary for Patent: 9,844,581

Title:	SDF-1 delivery for treating ischemic tissue
Abstract:	A method of treating a cardiomyopathy in a subject includes administering directly to or expressing locally in a weakened, ischemic, and/or peri-infarct region of myocardial tissue of the subject an amount of SDF-1 effective to cause functional improvement in at least one of the following parameters: left ventricular volume, left ventricular area, left ventricular dimension, cardiac function, 6-minute walk test, or New York Heart Association (NYHA) functional classification.
Inventor(s):	Penn; Marc S. (Beachwood, OH), Aras; Rahul (Broadview Heights, OH), Pastore; Joseph (Mentor, OH), Miller; Timothy J. (Cleveland Heights, OH)
Assignee:	The Cleveland Clinic (Cleveland, OH) Juventas Therapeutics, Inc. (Cleveland, OH)
Application Number:	14/100,050
Patent Claims:	1. An stromal cell-derived factor 1 (SDF-1) plasmid comprising an SDF-1.alpha. cDNA sequence having its expression driven by a cytomegalovirus (CMV) enhancer and promoter, CMV-intron A and the RU5 translational enhancer, wherein the plasmid is not contained within a nanoparticle. 2. The SDF-1 plasmid according to claim 1, wherein said plasmid comprises, in a 5' to 3' order, nucleotide sequences for a CMV enhancer, a CMV promoter, CMV-intron A, RU5, SDF-1.alpha., bovine growth hormone (BGH) polyA, and ColE1origin. 3. A preparation comprising an SDF-1 plasmid according to claim 1 and a pharmaceutically acceptable carrier, wherein said preparation does not include a transfection reagent. 4. The preparation according to claim 3, wherein said preparation is injectable. 5. The injectable preparation according to claim 4, wherein said pharmaceutically acceptable carrier is 5% dextrose. 6. The injectable preparation according to claim 4, comprising from about 0.33 mg/ml to about 5 mg/ml of said SDF-1 plasmid. 7. The injectable preparation according to claim 6, comprising about 2 mg/ml of said SDF-1 plasmid. 8. A method of treating an ischemic cardiomyopathy in a mammal comprising: administering to a weakened, ischemic, or peri-infarct region of the myocardium, by injection, a solution comprising from about 5 mg to about 100 mg of the plasmid of claim 1. 9. The method of claim 8, wherein the SDF-1 plasmid is administered to the weakened, ischemic, or peri-infarct region in multiple injections of the solution with each injection comprising from about 0.33 mg/ml to about 5 mg/ml of SDF-1 plasmid. 10. The method of claim 9, wherein each injection has a volume of at least 0.2 ml. 11. The method of claim 10, wherein the SDF-1 plasmid is administered to the weakened, ischemic, or peri-infarct region in at least 10 injections. 12. The method of claim 11, wherein the amount of SDF-1 plasmid administered to the weakened, ischemic, or peri-infarct region is about 5 mg. 13. The method of claim 11, wherein the volume of solution of SDF-1 plasmid administered to the weakened, ischemic, or peri-infarct region is about 10 ml. 14. The method of claim 8, wherein the SDF-1 plasmid is administered to the weakened, ischemic, or peri-infarct region in at least 10 injections of the solution with each injection comprising about 0.5 mg/ml to about 5 mg/ml of SDF-1 plasmid/solution and each injection has a volume of about 1.0 ml. 15. The method of claim 8, wherein SDF-1 is expressed at a therapeutically effective amount in the weakened, ischemic, or peri-infarct region for greater than three days. 16. The method of claim 8, wherein the myocardial tissue of the subject is imaged to define the area of weakened, ischemic, or peri-infarct region prior to administration of the SDF-1 plasmid and the SDF-1 plasmid is administered to the weakened, ischemic, or peri-infarct region defined by the imaging. 17. The method of claim 16, wherein the imaging includes at least one of echocardiography, magnetic resonance imaging, coronary angiogram, electroanatomical mapping, or fluoroscopy. 18. The method of claim 10, wherein the SDF-1 plasmid is administered to the weakened, ischemic, or peri-infarct region in at least 15 injections. 19. The method of claim 18, wherein the total amount of SDF-1 plasmid administered to the weakened, ischemic, or peri-infarct region is from about 15 mg to about 30 mg. 20. The method of claim 8, wherein the solution comprising a plasmid encoding SDF-1 further comprises a pharmaceutically acceptable carrier. 21. The method of claim 20, wherein the pharmaceutically acceptable carrier is dextrose.

Details for Patent 9,844,581

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Merck Sharp & Dohme Corp.	INTRON A	interferon alfa-2b	For Injection	103132	06/04/1986		2029-08-28
Merck Sharp & Dohme Corp.	INTRON A	interferon alfa-2b	For Injection	103132			2029-08-28
Merck Sharp & Dohme Corp.	INTRON A	interferon alfa-2b	Injection	103132			2029-08-28