Anti-angiogenic compositions and methods of use

[54] ANTI-ANGIOGENIC COMPOSITIONS AND METHODS OF USE

[75] Inventors: William L. Hunter; Lindsay S.

Machan, both of Vancouver; A. Larry
Arsenanlt, Paris, all of Canada

[73] Assignee: Angiogenesis Technologies, Inc..
Vancouver, Canada

[21] Appl. No.: 478,203
[22] Filed: Jun. 7, 1995

Related U.S. Application Data

[60] Division of Ser. No. 417,160, Apr. 3, 1995, abandoned, which is a continuation-in-part of Ser. No. 94,536, Jul. 19, 1993, abandoned.

[30] Foreign Application Priority Data

Jul. 19, 1994 [WO] WIPO PCI7CA94/00373

[51] Int CI.6 A61K 31/335; A61M 29/00

[52] U.S. CI 514/449; 128/898; 526/304;

528/421; 604/53; 604/20; 604/21; 604/96;

604/269; 606/198; 623/12

[58] Field of Search 604/53. 20, 21,

604/96, 269; 128/898; 514/449; 606/198;

623/12; 528/421; 526/304

[56] References Cited

U.S. PATENT DOCUMENTS

4,300,244 11/1981 Bokros 3/1.4

4,531,936 7/1985 Gordon 604/49

4,542,025 9/1985 Tice et al 424/78

4,580,568 4/1986 Gianturco 128/345

4,733,665 3/1988 Palmaz 128/343

4,739,762 4/1988 Palmaz 128/343

4,776,337 10/1988 Palmaz 128/343

4,800,882 1/1989 Gianturco 128/343

4,824,436 4/1989 Wolinsky 604/53

4,834,755 5/1989 Silvesteiiii et al 623/13

4,955,878 9/1990 Seeetal 604/181

4,960,790 10/1990 Stella etal 514/449

4,989,601 2/1991 Marchosky et al 128/399

4,990,155 2/1991 Wilkoff 606/191

5,019,090 5/1991 Pincmik 606/194

5,049,132 9/1991 Shaffer etal 604/101

5,053,048 10/1991 Pincmik 623/1

5,059,166 10/1991 Fischell et al 600/3

5,059,178 10/1991 Ya 604/101

5,059,211 10/1991 Stack etal 606/198

5,092,841 3/1992 Spears 604/96

5,102,417 4/1992 Palmaz 606/195

5,171,217 12/1992 March et al 604/53

5,171,262 12/1992 MacGregor 623/1

5,176,617 1/1993 Fischell etal 424/1.1

5,213,580 5/1993 Slepianetal 623/1

5234,456 8/1993 Silvestrini 606/194

5,286,254 2/1994 Shapeland et al 604/21

5,292,512 3/1994 Schaefer et al 424/401

5,304,121 4/1994 Sahatjian 604/53

5,314,688 5/1994 Kauffinan et al 424/423

5,342,348 8/1994 Kaplan 604/891.1

5,342,621 8/1994 Eury 424/423

5,380,299 1/1995 Fearnot et al 604/265

5,383,928 1/1995 Scott et al 623/1

5,403,858 4/1995 Bastard et al 514/449

5,407,683 4/1995 Shively 424/439

5,415,869 5/1995 Straubinger et al 424/450

5,419,760 5/1995 Narciso. Jr. 604/8

5,439,446 8/1995 Barry 604/96

5,439,686 8/1995 Desai et al 424/451

5,441,745 8/1995 Presant et al 424/450

5,447,724 9/1995 Helmus et al 424/426

5,449,513 9/1995 Yokoyama et al 424/78.08

5,457,113 10/1995 Cullman et al 514/319

5,460,817 10/1995 Langley et al 424/408

5,462,866 10/1995 Wang 435/174

5,464,450 11/1995 Buscemi et al 623/6

5,464,650 11/1995 Berg etal 427/2.3

5,473,055 12/1995 Mongelli et al 530/329

FOREIGN PATENT DOCUMENTS

375 520 Al 6/1990 European Pat. Off. .

470 569 Al 2/1992 European Pat. Off. .

566 245 Al 10/1993 European Pat. Off. .

567 816 Al 11/1993 European Pat. Off. . 627 226 Al 2/1994 European Pat. Off. . 679 373 A2 11/1995 European Pat. Off. .

WO 90/13332 11/1990 WIPO .

WO 91/10424 7/1991 WIPO .

WO 91/11193 8/1991 WIPO .

WO 91/12779 9/1991 WIPO .

WO 92/12717 8/1992 WIPO .

WO 92/15286 9/1992 WIPO .

WO 93/06792 4/1993 WIPO .

WO 94/21308 9/1994 WIPO .

WO 94/24961 11/1994 WIPO .

WO 95/03036 2/1995 WIPO .

WO 95/03795 2/1995 WIPO .

OTHER PUBLICATIONS

Walter et al., "Interstitial Taxol Delivered from a Biodegradable Polymer Implant against Experimental Malignant Glioma." Cancer Research 54:2207-2212. 1994. Bartoli et al.. "In vitro and in vivo antitumoral activity of free, and encapsulated taxol." Journal of Microencapsulation 7(2): 191-197, 1990.

Bissett and Kaye, 'Taxol and Taxotere—Current Status and Future Prospects," European Journal of Cancer 29A(9): 1228-1231, 1993.

De Scheerder et al.. "Biocompatibility of polymer-coated oversized metallic stents implanted in normal porcine coronary arteries," Atherosclerosis 114: 105-114, 1995.

(List continued on next page.)

Primary Examiner—Shailendra Kumar
Attorney, Agent, or Firm—Seed and Berry TIP

[57] ABSTRACT

The present invention provides compositions comprising an anti-angiogenic factor, and a polymeric carrier. Representative examples of anti-angiogenic factors include AntiInvasive Factor, Retinoic acids and derivatives thereof, and paclitaxel. Also provided are methods for embolizing blood vessels, and eliminating biliary, urethral, esophageal, and tracheal/bronchial obstructions.

18 Claims, 75 Drawing Sheets

OTHER PUBLICATIONS

Hoy et al.. "Design of Biodegradable Polymer Systems for Controlled Release of Bioactive Agents," in El-Nokaly et al. (eds.), Polymeric Delivery Systems: Properties and Applications, American Chemical Society, Washington, D.C., 1993, pp. 154-167.

Holland et al., "Polymers for Biodegradable Medical Devices. 1. The Potential of Polyesters as Controlled Macromolecular Release Systems," journal of Controlled Release 4: 155-180, 1986.

Jalil, R., "Biodegradable Poly(Lactic Acid) and Poly(Lactide-Co-Glycolide) Polymers in Sustained Drug Delivery," Drug Development and Industrial Pharmacy 16(16): 2353-2367. 1990.

Kohler and Goldspiel, "Evaluation of New Drugs. Paclitaxel
(Taxol)," Pharmacotherapy 14(1): 3-34, 1994.
Kuhn, J., "Pharmacology and Pharmocokinetics of Pacli-
taxel," Annals of Pharmacotherapy 28: S15-S17, 1994.
Langer. R., "1994 Whitaker Lecture: Polymers for Drug
Delivery and Tissue Engineering." Annals of Biomedical
Engineering 23: 101-111. 1995.

Passl. W., "Synthetic Polymers in Modern Pharmacy." Prog.
Polym. Sci. 14(5): 629-677, 1989.
Rowinsky et al., 'Taxol: A Novel Investigational Antimi-
crotubule Agent," Journal of the National Cancer Institute
82: 1247-1259, 1990.

Sauro et al., "The Anti-Tumor Agent. Taxol. Attenuates

Contractile Activity in Rat Aortic Smooth Muscle." Life

Sciences 56(7): PL 157-161. 1995.

Schindler et al., "Biodegradable Polymers for Sustained

Drug Delivery," Contemp. Top. Polym. Sci. 2:251-89,1977.

Sinko and Kohn, "Polymeric Drug Delivery Systems. An

Overview," in El-Nokaly et al. (eds). Polymeric Delivery

Systems: Properties and Applications, American Chemical

Society, Washington D.C., 1993, pp. 18-41.

Sollott et al., "Taxol Inhibits Neointimal Smooth Muscle

Cell Accumulation after Angioplasty in the Rat," Journal of

Clinical Investigation 95: 1869-1876, 1995.

Sonnichsen and Relling, "Clinical Pharmacokinetics of

Paclitaxel," Clin. PharmacoUnet. 27(4): 256-269, 1994.

Spencer and Faulds, "Paclitaxel. A Review of its Pharmacodynamic and Pharmacokinetic Properties and Therapeutic Potential in the Treatment of Cancer," Drugs 48(5): 794-847, 1994.

Vainionpaa et al., "Surgical Applications of Biodegradable Polymers in Human Tissues," Prog. Polym. Sci. 14: 679-716, 1989.

Yasumori et al., "Placement of Covered Self-Expanding Metallic Stents in the Common Bile Duct A Feasibility Study," Journal of Vascular and Interventional Radiology 4: 773-778. 1993.