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Details for Patent: 6,022,866

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Details for Patent: 6,022,866

Title: Use of hyaluronic acid and forms to prevent arterial restenosis
Abstract:A method is provided of inhibiting the narrowing of the vascular tubular walls of an animal by the proliferation of endothelial cells in the area of trauma after the vascular tubular walls have been traumatized, the method comprising the administration of a therapeutically effective non-toxic amount of a form of hyaluronic acid selected from the group consisting of hyaluronic acid and pharmaceutically acceptable salts thereof to the animal to inhibit the narrowing of the vascular tubular walls by the proliferation of endothelial cells into the area of trauma.
Inventor(s): Falk; Rudolf Edgar (Toronto, CA), Asculai; Samuel Simon (Toronto, CA), Turley; Eva Anne (Winnipeg, CA)
Assignee: Hyal Pharmaceutical Corporation (Mississauga, CA)
Filing Date:Mar 24, 1995
Application Number:08/403,766
Claims:1. A method of inhibiting the narrowing of the vascular tubular walls of an animal by the proliferation of endothelial cells in the area of trauma after the vascular tubular walls have been traumatized, the method comprising the administration of a therapeutically effective non-toxic amount of a form of hyaluronic acid selected from the group consisting of hyaluronic acid and pharmaceutically acceptable salts thereof, and a therapeutically effective amount of an agent selected from the group consisting of a non-steroidal anti-inflammatory drug (NSAID), Vitamin C, a stenosis inhibiting drug, an anti-oxidant, a free radical scavenger and combinations thereof for enhancing the effect of the form of hyaluronic acid administered in the inhibition of the narrowing of the tubular walls to the animal to inhibit the narrowing of the vascular tubular walls by the proliferation of the endothelial cells on the area of trauma, and wherein the molecular weight of the form of hyaluronic acid is less than 750,000 daltons and greater than 150,000 daltons.

2. The method of claim 1, wherein the molecular weight of the form of hyaluronic acid is greater than 150,000 daltons and less than 225,000 daltons.

3. The method of claim 2, wherein the tubular walls are arteries which have been subjected to balloon angioplasty and the administration takes places before, during or after the balloon angioplasty.

4. The method of claim 3 wherein the amount of the form of hyaluronic acid administered is between 10 mg and 3000 mg.

5. A method of inhibiting arterial restenosis of the arterial wall by the proliferation of endothelial cells on the inner wall of the artery after balloon angioplasty in a human, the method comprising the administration of a therapeutically effective non-toxic amount of a form of hyaluronic acid selected from the group consisting of hyaluronic acid, pharmaceutically acceptable salts thereof and combinations thereof, a therapeutically effective amount of an agent selected from the group consisting of a non-steroidal anti-inflammatory drug (NSAID), Vitamin C, a stenosis inhibiting drug, an anti-oxidant, a free radical scavenger and combinations thereof for enhancing the effect of the form of hyaluronic acid administered in the inhibition of the narrowing of the tubular walls to the human to inhibit arterial restenosis by the proliferation of endothelial cells on the inner wall of the artery, and wherein the molecular weight of the form of hyaluronic acid is less than 750,000 daltons and greater than 150,000 daltons.

6. The method of claim 5, wherein the molecular weight of the form of hyaluronic acid is greater than 150,000 daltons and less than 225,000 daltons.

7. The method of claim 5, wherein the amount of the form of hyaluronic acid administered is between 10 mg and 3000 mg.

8. The method of claim 5, 6, or 7 wherein the form of hyaluronic acid is administered prior to, during or after the balloon angioplasty.

9. The method of claim 1, 2, 3, 4, 5, 6, or 7 wherein the form of hyaluronic acid is sodium hyaluronate administered intravenously.

10. The method of claim 1, 2, 3, 4, 5, 6 or 7 wherein the therapeutically effective amount of the combination of the form of hyaluronic acid and agent are in the form for intravenous administration.

11. A method of inhibiting arterial restenosis of the arterial wall by the proliferation of endothelial cells on the area of trauma after balloon angioplasty, the method comprising the administration of a therapeutically effective non-toxic amount of hyaluronic acid and/or pharmaceutically acceptable salts thereof whose molecular weight is less than 750,000 daltons and greater than 150,000 daltons, and a therapeutically effective amount of an agent selected from the group consisting of a non-steroidal anti-inflammatory drug (NSAID), Vitamin C, a stenosis inhibiting drug, an anti-oxidant, a free radical scavenger and combinations thereof for enhancing the effect of the form of hyaluronic acid administered in the inhibition of the narrowing of the tubular walls to inhibit arterial restenosis by the proliferation of the endothelial cells on the area of trauma.

12. The method of claim 11, wherein the amount of the hyaluronic acid and/or salts thereof administered is between 10 mg and 3000 mg.

13. The method of claim 12 wherein the NSAID is an effective dosage amount and the amount of hyaluronic acid and salts thereof exceeds 200 mg.

14. A pharmaceutical composition comprising together with diluents, adjuvants and other pharmaceutical carriers as desired;

(1) an effective amount of a form of hyaluronic acid selected from the group consisting of hyaluronic acid, pharmaceutically acceptable salts thereof, and combinations thereof, and

(2) an agent selected from the group consisting of a stenosis inhibiting drug, a non-steroidal anti-inflammatory drug (NSAID), Vitamin C, a free radical scavenger, and an anti-oxidant and combinations thereof, for inhibiting the narrowing of the vascular tubular walls of an animal by the build-up of endothelial cells on the vascular tubular walls after the tubular walls have been traumatized, the composition being characterized by an effective non-toxic amount of the form of hyaluronic acid being incorporated into the composition together with a therapeutically effective amount of agent (2), to inhibit tubular wall narrowing by the build-up of endothelial cells on the vascular tubular walls, wherein the effective amount of component (1) is between 10 mg to 3000 mg to prevent the narrowing of the tubular walls of the animal by the build-up of endothelial cells on the vascular tubular walls and wherein component (2) enhances the effect of component (1) in the prevention of the narrowing of the tubular walls by the build-up of endothelial cells on the vascular tubular walls, and wherein the molecular weight of component (1) is less than 750,000 daltons and greater than 150,000 daltons.

15. The composition of claim 14 wherein the molecular weight of component (1) is greater than 150,000 daltons and less than 225,000 daltons.

16. The composition of claim 14 or 15 wherein component (1) comprises a stenosis-inhibiting drug and an NSAID.

17. The composition according to claim 14 or 15 in injectable or intravenous form and component (1) is sodium hyaluronate.

18. The method of claim 14 or 15, wherein component (1) is utilized at a dose between 10 mg to 1000 mg.

19. The composition of claim 14 or 15, wherein the amount of component (1) is greater than 200 mg.

20. The composition of claim 19 wherein the pharmaceutical composition is for inhibition of arterial restenosis after balloon angioplasty in humans.
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