IP Library Granted Patent US 8,932,638
Granted Patent B2
US 8,932,638 · App. 13/791,102 · Granted Jan 13, 2015

Polyamine derivatives

Inventors: Gregory Slobodkin (Huntsville, AL); Richard Congo (Huntsville, AL); Majed Matar (Madison, AL); Jason Fewell (Madison, AL); Khursheed Anwer (Madison, AL); Brian Jeffery Sparks (Huntsville, AL)
Assignee: CLSN Laboratories, Inc.
A61K31/713C07C233/38C07C235/10C07C235/60A61K47/16A61K47/48061A61K47/48946A61K9/1272C07D475/04C07H15/10C07K7/23C07K7/64A61K47/48815
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Quick Facts
Patent No.
US 8,932,638
App. No.
13/791,102
Granted
Jan 13, 2015
Kind
B2
Abstract

Disclosed are compounds, compositions and methods for systemic and local delivery of biologically active molecules.

Claims (33)

1. A compound of the formula:

n1, n2, and n3 are independently 1, 2, 3, or 4;

X and X′ are independently a bond, oxygen, or nitrogen;

R 1 and R 2 are independently C 8 -C 25 hydrocarbon groups optionally containing from 1-4 double or triple bonds; and

-G is a polyoxyalkylene, polyvinylpyrrolidone, polyacrylamide, polydimethylacrylamide, polyvinyl alcohol, dextran, poly (L-glutamic acid), styrene maleic anhydride, poly-N-(2-hydroxypropyl)methacrylamide, or polydivinylether maleic anhydride.

2. A compound according to claim 1 , wherein n1, n2, n3, and n4 are all 1, and X and X′ are bonds.

3. A compound according to claim 1 , wherein R 1 and R 2 are independently C 14 -C 20 hydrocarbon groups containing 1 double bond.

4. A compound according to claim 3 , wherein both of —C(O)X—R 1 and —C(O)X′—R 2 are oleoyl groups.

5. A compound according to claim 1 , wherein G comprises at least one linker group between polymer units.

6. A compound according to claim 1 , G is a polyoxyalkylene.

7. A formulation comprising the compound of claim 1 and a molecule selected from the group consisting of:

(a) ribosomal RNA; antisense polynucleotides of RNA or DNA; aptamers; ribozymes; siRNA; shRNA; miRNA; and polynucleotides of genomic DNA, cDNA, or mRNA that encode for a therapeutically useful protein; or

(c) proteins, peptides, cholesterol, hormones, small molecule pharmaceutical compounds, vitamins, and co-factors.

8. A formulation according to claim 7 , where the formulation comprises particles comprising the compound and the molecule.

9. A formulation according to claim 8 , where the particles have a median diameter of less than about 500 nm.

10. A method of modulating expression of a target sequence, said method comprising administering to a mammalian subject a therapeutically effective amount of the formulation of claim 7 .

11. A formulation comprising a compound of formula A and a compound of Formula B

wherein n1, n2, and n3 are independently 1, 2, 3, or 4;

X and X′ are independently a bond, oxygen, or nitrogen;

R 1 and R 2 are independently C 8 -C 25 hydrocarbon groups optionally containing from 1-4 double or triple bonds; and

in Formula A, G is hydrogen; and

in Formula B, -G is a polyoxyalkylene, polyvinylpyrrolidone, polyacrylamide, polydimethylacrylamide, polyvinyl alcohol, dextran, poly (L-glutamic acid), styrene maleic anhydride, poly-N-(2-hydroxypropyl)methacrylamide, or polydivinylether maleic anhydride;

and a molecule selected from the group consisting of:

(a) ribosomal RNA; antisense polynucleotides of RNA or DNA; aptamers; ribozymes; siRNA; shRNA; miRNA; and polynucleotides of genomic DNA, cDNA, or mRNA that encode for a therapeutically useful protein.

12. A method for in vivo delivery of ribosomal RNA; antisense polynucleotides of RNA or DNA; aptamers; ribozymes; siRNA; shRNA; miRNA; and polynucleotides of genomic DNA, cDNA, or mRNA that encode for a therapeutically useful protein to a mammalian subject comprising administering to the subject the formulation of claim 11 .

13. A formulation according to claim 11 , wherein the ratio of the compound of Formula A to the compound of Formula B in the formulation is 1:1 to 10:1.

14. A composition comprising a compound of formula A and a compound of Formula B

wherein n1, n2, and n3 are independently 1, 2, 3, or 4;

X and X′ are independently a bond, oxygen, or nitrogen;

R 1 and R 2 are independently C 8 -C 25 hydrocarbon groups optionally containing from 1-4 double or triple bonds; and

in Formula A, G is hydrogen; and

in Formula B, -G is a polyoxyalkylene, polyvinylpyrrolidone, polyacrylamide, polydimethylacrylamide, polyvinyl alcohol, dextran, poly (L-glutamic acid), styrene maleic anhydride, poly-N-(2-hydroxypropyl)methacrylamide, or polydivinylether maleic anhydride.

15. A formulation according to claim 14 , wherein the ratio of the compound of Formula A to the compound of Formula B in the formulation is 1:1 to 10:1.

Assignments (2)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Sep 22, 2014
From: EGEN, INC.
To: CLSN LABORATORIES, INC.
Reel/Frame 033788/0539 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Apr 25, 2014
From: SLOBODKIN, GREGORY; CONGO, RICHARD; MATAR, MAJED; FEWELL, JASON; ANWER, KHURSHEED; SPARKS, BRIAN JEFFREY
To: EGEN, INC.
Reel/Frame 032761/0661 →
Continuity (3)
Division 12727987 · Mar 19, 2010
Provisional Application 61161828 · Mar 20, 2009
Related Publication 20130251809A1 · Sep 26, 2013