(12) United States Patent (10) Patent No.: US 8,697,347 B2
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USOO8697347B2 (12) UnitedO States Patent (10) Patent No.: US 8,697,347 B2 Sehgal (45) Date of Patent: *Apr. 15, 2014 (54) COMPOSITION FOR PRESERVING OTHER PUBLICATIONS PLATELETS AND METHOD OF USING THE SAME Furman et al., “GPllb-Illa Antagonist-induced Reduction in Platelet Surface Factor ViVa Binding and Phosphatidylserine Expression in (75) Inventor: Lakshman R. Sehgal, Monarch Beach, Whole Blood”. Thromb. Haemost. 84: 492-8 (2000).* CA (US) Uzan, 'Antithrombotic agents'. Chapter 12, Emerging Drugs 3 : 189-208 (1998).* (73) Assignee: Biovec Transfusion, LLC, Chicago, IL Agranenko et al., “Preparing platelet concentrates from banked blood (US) stored for 1-5 days by using tetracycline antibiotics”. Folia Haematologica 110 (6): 879-86 (1982), abstract only.* ( c ) Notice: Subject to any disclaimer, the term of this International Search Report (Application No. PCT/US2003/038.125, patent is extended or adjusted under 35 filed Dec. 2, 2003). U.S.C. 154(b) by 300 days. Abendschein. D.R., et al., “Effects of ZK-807834, a Novel Inhibitor of Factor Xa, on Arterial and Venous Thrombosis in Rabbits', J. This patent is Subject to a terminal dis- Cardiovasc. Pharmacol., vol. 35. No. 5, pp. 796-805, retrieved Oct. claimer. 11, 2006, <http:\\gateway.ut.ovid.com.gwllovidweb.cgi>, May 2000. (21) Appl. No.: 13/098,128 Ostrem, JA, et al., “Discovery of a Novel, Potent, and Specific Family of Factor Xa Inhibitors via Combinatorial Chemistry, Biochemistry, (22) Filed: Apr. 29, 2011 vol. 37, No. 4, pp. 1053-1059, 1998. Hirsh, J. et al., “New antithrombotic agents'. The Lancet, vol. 353, (65) Prior Publication Data pp. 1431-1436, Apr. 24, 1999. Pinto, Donald J.P. et al., “Discovery of 1-3-(Aminomethyl)phenyl US 2011 FO223663 A1 Sep. 15, 2011 N-3-fluoro-2'-(methylsulfonyl)-1, 1'-biphenyl-4-yl)-3- (trifluoromethyl)-1H-pyrazole-5-carboxamide (DPC423), a Highly O O Potent, Selective, and Orally Bioavailable Inhibitor of Blood Coagul Related U.S. Application Data lation Factor Xal'. J. ME vol. 44, pp. 566-578, ise (63) Continuation of application No. 1 1/330,132, filed on Pruitt, James R. et al., “Isoxazolines and Isoxazoles as Factor Xa Jan. 12, 2006, now Pat. No. 7.964.338. Inhibitors'. Bioorg. Med. Chem. Lett., vol. 10, pp. 685-689, (2000). s s s- Y is Quan, Mimi L. et al., “Design and Synthesis of Isoxazoline Deriva (60) Provisional application No. 60/643,107, filed on Jan. tives as Factor Xa Inhibitors'.J.Med. Chem... vol.42, pp. 2752-2759, 12, 2005. (1999). Sato. K. et al. “Relationship between the antithrombotic effect (51) Int. Cl. ofYM-75466, a novel factor Xa inhibitor, and coagulationparameters AOIN I/02 (2006.01) in rats'. European Journal of Pharmacology, vol. 347, pp. 231-236. (52) U.S. Cl. ().ong, P.C., et al., “Non& 8 peptide Factor Xa. Inhibitors:1- Faro, I. Studies with USPC .............................................................. 435/2 SF303 and SK549, a New Class of Potent Antithrombotics', The (58) Field of Classification Search Journal of Pharmacology and Experimental Therapeutics, vol. 292, None No. 1, pp. 351-357, (2000). See application file for complete search history. Fareed, J. et al., “New antithrombotic drugs: A perspective'. Current Opinion in Cardiovascular, Pulmonary & Renal Investigational (56) References Cited Drugs, vol. 1, No. 1, pp. 40-55, (1999). Mousa, S. et al., “Vasoactive Role of the aWll3 iNtegrin in Rabbit U.S. PATENT DOCUMENTS Carotid Artery: Endothelium-Dependent and Independent Effects' Abstracts from the 71st Scientific Sessions, No. 179, pp. 1-37, 4,455.299 A * 6/1984 Grode ........................... 424,532 Undated. 4,800,016 A 1/1989 Yang 5,256.559 A * 10/1993 Maraganore et al. ... 424,153.1 (Continued) 5,798.238 A 8/1998 Goodrich, Jr. et al. 5,801,063 A 9, 1998 Grandics et al. Primary Examiner — Sandra Saucier 3.35 A 38 M. al. (74) Attorney, Agent, or Firm — Ping Wang: Andrews Kurth, 5,919,614 A * 7/1999 Livesey et al. .................... 435/2 LLP 5,955,256 A 9, 1999 SOwenimo-Coker et al. 5,981,163 A 11/1999 Horowitz et al. (57) ABSTRACT 6,030,767 A 2/2000 Wagner et al. 6,087,141 A 7/2000 Margolis-Nunno et al. The present invention relates to compositions and methods 6,106,773. A 8, 2000 Miekka et al. for storing platelets to preserve the function and freshness of 6,733,471 B1 5/2004 Ericson et al. the platelets. More particularly, the present invention relates 8373 R ck 1239 insta . 530/402 to the use of a preservative composition having an antiplatelet 7.964.338 B2 * 6/2011 Sehgal et al. ..................... 435.2 agent, an anticoagulant, and an oxygen carrier, for maintain 8,129.103 B2 * 3/2012 Sehgal et al. .. ... 435.2 ing the freshness of platelets. Additionally, the composition 8,129,104 B2 * 3/2012 Sehgal et al. .. ... 435.2 may also contain an ultra-short acting broad spectrum anti 8,142,992 B2 : 3/2012 Sehgal et al. ... 435.2 microbial agents. The preservative composition may be used 200 of: R ck 3i E, Ogosi to store platelets in a liquid state, a frozen state, or a freeze 2004/0223957 A1 11/2004 Lucas et al. dried state. 2008. O138791 A1 6, 2008 Hoffmeister et al. 2010, 0221697 A1 9/2010 Sehgal 18 Claims, 3 Drawing Sheets US 8,697,347 B2 Page 2 (56) References Cited Notification of Transmittal of the International Search Report and the Written Opinion of the International Searching Authority of Interna OTHER PUBLICATIONS tional Application No. PCT/US2011/025432 dated Dec. 29, 2011. 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Mousa, SA, et al., “Comparative InVitro Efficacy of Different Plate Gerbutavicius, R. et al., “Differential effects of DX-9065a, let GPll/b/ilia Antagonists on the Dynamic of 14 Platelet I Fibrin argatroban, and synthetic pentasaccharide on tissue thromboplastin Mediated Clot Strength Induced by Different Mediators. Using inhibition test and dilute Russell's viper venomtest”, (Abstract only) Thromboelastography: Differential Efficacy”. Running title: “Plate Clin. Appl. Thromb. Hemost. (Oct. 9, 2003)4, 317-323. let GPllb/lla and PlatelellFibrin Clot Retraction', (Paper submitted) Beilfu, A et al., “Differential Effects of Factor lla Inhibitors on the pp. 1-21. Undated. Endogenous Thrombin Potential”. Therapeutic Drug Monitoring, Supplementary European Search Report dated Oct. 27, 2011 of Inter Dec. 2008, vol. 30(6):740–743. (Abstract). national Application No. 06718042.2. WarnholTZ. Ascan, et al., “Vasoactive Role of the aW1b3 iNtegrin in Bode, A., et al., “Extended Storage of Platelets in an Artificial Rabbit Carotid Artery: Endothelium-Dependent and Independent Medium with the Platelet Activation Inhibitors Prostaglandin E1 and Effects', American Heart Association, 71st Scientific Sessions, Nov. Theophylline'', Vox Sang, 1991, No. 60, pp. 105-112. 8-11, 1998. Leytin, V. et al., “Hemolink, an o-raffinose cross-linked Mousa, Shaker A. et al., "Comparison of the Effect of Different haemoglobin-based oxygen carrier, does not affect activation and Platelet GPllbilla Antagonists on the Dynamics of Platelet/Fibrin function of human platelets in whole blood in vitro”, (Abstract only), Mediated Clot Strength Induced Using Thromboelastography”. Brit J Haemetology (2003), 120 (3), 535-541. Thrombosis Research, Jul. 3, 2001, vol. 104, pp. 49-56. Friesch, T. et al., “Artificial oxygen carriers’. European Journal of Anaesthesiology, vol. 15, 1998, pp. 571-584. * cited by examiner U.S. Patent Apr. 15, 2014 Sheet 1 of 3 US 8 9697,347 B2 87][50]=| ERHIWANOIS?HO_L U.S. Patent Apr. 15, 2014 Sheet 2 of 3 US 8,697,347 B2 EFFECT OF b/a ANTAGONST C7E3 ON TISSUEFACTOR MEDIATED CLOT RETRACTION INHUMAN WHOLE BLOOD THROMBOELASTOGRAPHY TF4 g/ml FIG 2A C7E3 29 nM 58 nM 116 nM 42 3 AM FIG 2B 60 20 --O-AGGREGATIONIC50=79nM -HTEGIC50= 68nM FIG 2C U.S. Patent Apr. 15, 2014 Sheet 3 of 3 US 8,697,347 B2 ?NICINIGNEÐONIHgI4-lgzy +ISINOÐVLNVvº) CJOOTEETOHNA ‘SHHZ<| US 8,697,347 B2 1. 2 COMPOSITION FOR PRESERVING this short shelf-life is that platelets must be collected close to PLATELETS AND METHOD OF USING THE their time of use, which makes it extremely difficult to coor SAME dinate platelet collection and platelet Supply.