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| Hai Lama Mtandao Wa Wananchi Wana Haiti |HAI LAMA MTANDAO US009757411B2WA WANANCHI WANA HAITI (12 ) United States Patent ( 10 ) Patent No. : US 9 ,757 ,411 B2 Emanuele et al. ( 45) Date of Patent: Sep. 12, 2017 ( 54 ) POLOXAMER THERAPY FOR HEART 5 ,080 , 894 A 1 / 1992 Hunter .. .. .. .. .. .. .. 424 / 83 5 ,089 , 260 A 2 / 1992 Hunter .. 424 / 83 FAILURE 5 ,523 , 492 A 6 / 1996 Emanuele et al . .. .. .. 568 /606 5 ,567 , 859 A 10 / 1996 Emanuele et al . 568 /624 @(71 ) Applicant : Mast Therapeutics , Inc . , San Diego , 5 ,605 ,687 A 2 / 1997 Lee . 424 /78 . 06 CA (US ) 5 ,691 , 387 A 11/ 1997 Emanuele et al . .. .. .. .. 568 / 723 5 ,696 , 298 A 12 / 1997 Emanuele et al. .. .. 568 /623 @(72 ) Inventors : R . Martin Emanuele , San Diego , CA 5 , 800 , 711 A 9 / 1998 Reeve et al. 210 /639 5 ,990 ,241 A 11/ 1999 Emanuele et al . .. 525 / 88 (US ) ; Santosh Vetticaden , San Diego , RE36 ,665 E 4 /2000 Emanuele et al. 568 /624 CA (US ) ; Patrick Keran , Cardiff , CA RE37 , 285 E 7 / 2001 Emanuele et al. 514 / 723 (US ) 6 , 359, 014 B1 3 / 2002 Emanuele et al. 514 / 723 6 , 747 , 064 B2 6 / 2004 Emanuele et al. 514 / 44 @( 73 ) Assignee : Aires Pharmaceuticals , Inc. , Austin , RE38 , 558 E 7 / 2004 Emanuele et al. .. .. .. .. 568 /623 6 ,761 , 824 B2 7 / 2004 Reeve et al. .. .. .. .. .. .. 210 /639 TX (US ) 6 , 977, 045 B2 12 / 2005 Reeve et al . .. .. .. .. 210 /639 7 , 846 , 426 B2 12 / 2010 Metzger et al. .. .. .. 424 / 78 . 38 ( * ) Notice: Subject to any disclaimer, the term of this 8 ,372 , 387 B2 2 / 2013 Markham et al. .. .. 424 / 78 . 31 patent is extended or adjusted under 35 8 , 580 , 245 B2 11 /2013 Metzger et al . .. .. .. .. 424 / 78 . 38 U . S . C . 154 (b ) by 0 days . 8 , 852 , 568 B2 10 / 2014 Ng et al. .. .. .. .. 424 / 78 . 3 2002 / 0183398 A1 12 / 2002 Emanuele et al. .. .. .. 514 / 44 2003 / 0206910 AL 11 /2003 Nicol et al. .. .. .. 514 /44 ( 21) Appl. No .: 14 /793 ,662 2004 / 0258718 A1 12 /2004 Meadows et al. .. .. 424 /70 . 15 2005/ 0095221 Al 5 / 2005 Balasubramanian (22 ) Filed : Jul. 7 , 2015 et al . .. .. 424 / 78 . 38 2007 /0237740 A110 /2007 Reddington et al . .. .. 424 / 78 .38 (65 ) Prior Publication Data 2008 /0260681 A1 10 /2008 Metzger et al. .. 424 / 78 . 38 2008 /0269449 A1 10 /2008 Chattopadhyay et al . 526 /329 . 7 US 2016 / 0000822 A1 Jan . 7 , 2016 2009 / 0246162 Al 10 / 2009 Markham et al . .. .. 424 /400 2010 /0178269 AL 7 / 2010 Markham et al. .. .. .. 424 / 78 . 18 Related U . S . Application Data 2011 /0033412 AL 2 / 2011 Ng et al . .. .. 424 / 78 . 3 (63 ) Continuation - in - part of application No. 2011 / 0044935 AL 2 /2011 Metzger et al . .. 424 / 78 . 38 2011 /0212047 A1 * 9 / 2011 Hunter . .. .. .. .. .. .. A61K 31 / 337 PCT/ US2014 /045627 , filed on Jul. 7 , 2014 . 424 / 78 . 17 (60 ) Provisional application No .62 / 126 , 400 , filed on Feb . ( Continued ) 27, 2015 , provisional application No . 62 /021 , 691 , filed on Jul . 7 , 2014 . FOREIGN PATENT DOCUMENTS (51 ) Int. CI. Wo WO 94 /08596 4 / 1994 A61F 2 /00 ( 2006 .01 ) WO WO 2006 /037031 4 / 2006 A61K 31 / 765 ( 2006 .01 ) (Continued ) A61K 45 / 06 ( 2006 .01 ) n A61K 9 / 00 ( 2006 .01 ) OTHER PUBLICATIONS ( 52 ) U . S . CI. CPC .. .. .. .. A61K 31/ 765 (2013 . 01 ) ; A61K 45 / 06 U . S . Appl. No. 14 /793 ,670 , filed Jul. 7 , 2015 . a U . S . Appl. No. 14 /793 ,730 , filed Jul. 7 , 2015. ( 2013 .01 ) ; A61K 9 /0024 (2013 .01 ) Letter /Written Disclosure of the Supplemental Information Disclo (58 ) Field of Classification Search sure Statement for the above - referenced application , filed herewith None Sep . 24 , 2015 , 2 pages. See application file for complete search history . Sabbah et al. , “ A canine model of chronic heart failure produced by multiple sequential coronary microembolizations, ” Am J Physiol ( 56 ) References Cited 260 :H1379 -H1384 ( 1991 ) . U . S . PATENT DOCUMENTS (Continued ) 4 , 522 .811 A 6 / 1985 EppsteinEppstein et al. .. .. .. .. .. .. .. 514 / 2 4 , 801 , 452 A 1 / 1989 Hunter 424 / 94 .63 Primary Examiner — Susan Tran 4 , 837 ,014 A 6 / 1989 Hunter et al . .. .. .. .. .. .. .. 424424 / 78 4 , 873 ,083 A 10 / 1989 Hunter et al. 424 / 83 ( 74 ) Attorney , Agent, or Firm — Think IP , PC ; Robert 4 , 879 ,109 A 11/ 1989 Hunter 424 / 83 Prince 4 , 897 , 263 A 1 / 1990 Hunter 424 / 83 4 , 937 , 070 A 6 / 1990 Hunter . .. .. 424 /83 4 , 997 ,644 A 3 / 1991 Hunter 424 / 83 5 ,017 , 370 A 5 / 1991 Hunter 424 / 83 (57 ) ABSTRACT 5 , 028 , 599 A 7 / 1991 Hunter 424 / 83 5 , 030 ,448 A 7 / 1991 Hunter . .. 514 /83 Provided methods of administering poloxamer 188 for treat 5 ,032 , 394 A 7 / 1991 Hunter . 424 /83 ing heart failure by only a single short relatively high dose 5 , 039 ,520 A 8 / 1991 Hunter 424 /83 infusion , or by regimen that includes the single infusion 5 ,041 , 288 A 8 / 1991 Hunter . .. * ** * 424 / 83 5 ,047 ,236 A 9 / 1991 Hunter 424 /83 followed by additional infusions at intervals of 1 - 4 weeks. 5 , 064 ,643 A 11/ 1991 Hunter 424 / 83 5 ,071 , 649 A 12 / 1991 Hunter . 424 / 83 5 ,078 ,995 A 1 / 1992 Hunter . .. .. .. .. 424 / 83 37 Claims, 19 Drawing Sheets US 9 , 757 ,411 B2 Page 2 ( 56 ) References Cited Zile et al ., “ New concepts in diastolic dysfunction and diastolic heart failure : Part 1 : diagnosis , prognosis , and measurements of U . S . PATENT DOCUMENTS diastolic function ,” Circulation 105 ( 11 ) : 1387 - 1393 (2002 ) . Zile et al ., " Heart failure with preserved ejection fraction : is this 2013 /0129662 A1 5 / 2013 Markham et al . .. .. 424 /78 . 31 2013 /0177524 Al 7 /2013 Emanuele et al. .. .. 424 / 78 . 31 diastolic heart failure ? ," J Am Coll Cardiol 41 ( 9 ) : 1519 - 1522 ( 2003 ) . 2014 /0056839 Al 2 / 2014 Zhang et al . .. .. .. .. .. 424 /78 .06 Zimmerli et al. , “ Urinary proteomic biomarkers in coronary artery 2015 /0030559 AL 1 / 2015 Ng et al. .. 424 / 78 . 3 disease , ” Mol Cell Proteomics 7 ( 2 ) : 290 - 298 ( 2008 ) . 2015 / 0093368 A1 4 / 2015 Emanuele et al. 424 / 78 . 31 Zhang et al ., “ Poloxamer 188 prolongs survival of hypotensive 2015 /0190421 A1 7 / 2015 Markham et al. .. .. .. .. 424 / 78 . 3 resuscitation and decreases vital tissue injury after full resuscita tion ,” Shock 32 ( 4 ) :442 -450 (2009 ) . FOREIGN PATENT DOCUMENTS International Search Report and Written Opinion , mailed Aug . 19 , 2014 , in connection with International Patent Application No. WO WO 2006 /044738 4 /2006 PCT/ US2014 /045627 , 12 pages . WO WO 2006 / 091941 8 / 2006 Written Opinion , mailed Jan . 16 , 2015 , in connection with Interna WO WO 2008 / 016640 2 / 2008 WO WO 2009 /023177 2 / 2009 tional Patent Application No . PCT/ US2014 /045627 , 7 pages . WO WO 2012 /068079 5 / 2012 International Search Report and Written Opinion , mailed Sep . 8 , WO WO 2012 /091361 7 / 2012 2015 , in connection with International Patent Application No . WO WO 2015 /058013 4 / 2015 PCT/US2015 /039426 , 17 pages. International Search Report and Written Opinion , mailed Sep . 11, 2015 , in connection with International Patent Application No . OTHER PUBLICATIONS PCT/US2015 /039418 , 15 pages . International Search Report and Written Opinion , mailed Sep . 8 , Sabbah et al ., “ Hemodynamic properties of a new - generation posi 2015 , in connection with International Patent Application No . tive luno - inotropic agent for the acute treatment of advanced heart PCT/ US2015 / 039456 , 15 pages . failure , ” Am J Cardiol 99: 41 A -46A (2007 ) . International Search Report and Written Opinion , mailed Dec . 2 , Sabbah et al. , “ Short ( 2 hour ) intravenous infusion of purified 2014 , in connection with International Patent Application No. poloxamer 188 (MST -188 ) elicits prolonged ( 1 - 2 weeks) improve PCT/ US2014 /060982 , 15 pages . ment in LV ejection fraction and suppresses elevations of plasma Response , filed Aug. 17 , 2015 , to International Search Report and Troponin - I and nt- pro Brain Natriuretic Peptide in dogs with Written Opinion , mailed Dec . 2 , 2014 , in connection with Interna advanced heart failure, " J Cardiac Failure 20 ( 8 ) : S8 - 59 (2014 ) . tional Patent Application No . PCT /US2014 /060982 , 34 pages . Schaer et al . , “ Beneficial effects of RheothRx injection in patients Mast Therapeutics Press Release Jan . 6 , 2014 , “ Mast Therapeutics receiving thrombolytic therapy for acute myocardial infraction : Announces Positive Data in Model of Heart Failure ,” results of a randomized , double- blind , placebo - controlled trial, " [online ] [ retrieved on May 20 , 2014 ] Retrieved from : < URL :masttherapeutics . com / investors /news / ? releaseid Circulation 94 :298 - 307 ( 1996 ) . 1887966 > , 2 pages . Schaer et al ., “ Reduction in reperfusion - induced myocardial necro Mast Therapeutics Press Release Feb . 18 , 2014 , “ Mast Therapeutics sis in dogs by RhethRx injection (poloxamer 188 N . F .) , a Provides Additional Results from Nonclinical Heart Failure Study, " hemorheological agent that alters neutrophil function , ” Circulation [online ][ retrieved on May 20 , 2014 ] Retrieved 90 ( 6 ) : 2964 - 2975 ( 1994 ) . from : < URL :masttherapeutics . com /investors / news/ Shirakabe et al ., “ Clinical significance of matrix metalloproteinase ? releaseid = 1900672 > , 3 pages. (MMP ) - 2 in patients with acute heart failure, ” Int Heart J 51( 6 ) : Mast Therapeutics: United States Securities and Exchange Com 404 - 410 ( 2010 ) . mission Form 10 - K Annual Report Pursuant to Section 13 or 15 ( d ) Schmolka, I. , “ A review of block polymer surfactants ,” Am Oil of the Securities Exchange Act of 1934 , for the fiscal year ended Chem Soc 54 : 110 -116 ( 1977) . Dec . 31, 2013 [online ] [ retrieved Aug . 26 , 2015 ] Retrieved from Smith , H . and A . Nuttall, “ Experimental models of heart failure , ” < URL :masttherapeutics . com / investors /secfilings / ? group = All Cardiovasc Res 19 ( 4 ) : 181 - 186 ( 1985 ) . & pg = 6 , 131 pages . Spurney et al. , “ Membrane sealant poloxamer P188 protects against Mast Therapeutics , “ A Brief History of MST- 188, " isoproterenol induced cardiomyopathy in dystrophin deficient [online ] [retrieved on May 20 , 2014 ] Retrieved from <URL :sec .
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