Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Peptide containing doai
Reexamination Certificate
2006-08-01
2006-08-01
Weber, Jon (Department: 1653)
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
Peptide containing doai
C530S350000
Reexamination Certificate
active
07084118
ABSTRACT:
The invention concerns an improved therapeutic regimen for the treatment of thrombolytic disorders, such as acute myocardial infarction (AMI). In particular, the present invention concerns the treatment of thrombolytic disorders, e.g. AMI, with a combination of a tissue plasminogen activator (t-PA) variant having improved fibrin specificity and extended plasma half-life when compared with wild-type human t-PA and a low molecular weight heparin.
REFERENCES:
patent: 4281108 (1981-07-01), Fussi
patent: 4687765 (1987-08-01), Vairel et al.
patent: 4766075 (1988-08-01), Goeddel et al.
patent: 4977250 (1990-12-01), Diaz et al.
patent: 5106734 (1992-04-01), Nielsen
patent: 5130143 (1992-07-01), Strickland et al.
patent: 5279824 (1994-01-01), Sawyer et al.
patent: 5308617 (1994-05-01), Halluin
patent: 5389618 (1995-02-01), Debrie
patent: 5510330 (1996-04-01), Martin et al.
patent: 5576304 (1996-11-01), Kakkar et al.
patent: 5612029 (1997-03-01), Bennett et al.
patent: 5690931 (1997-11-01), Martin et al.
patent: 5753702 (1998-05-01), Bednar et al.
patent: 5849689 (1998-12-01), Chamow et al.
patent: 6235279 (2001-05-01), Martin et al.
patent: 0238304 (1987-09-01), None
patent: 0238304 (1987-09-01), None
patent: 0 372 969 (1990-06-01), None
patent: 0 643 772 (1997-07-01), None
patent: WO 89/04368 (1989-05-01), None
patent: WO 95/26202 (1995-10-01), None
patent: WO 00/53168 (2000-09-01), None
Single-bolus tenecteplase compared with front-loaded alteplase in acute myocardial infarction: the ASSENT-2 double-blind randomised trial. Assessment of the Safety and Efficacy of a New Thrombolytic Investigators. Lancet. Aug. 28, 1999;354(9180):716-22.
Efficacy and safety of tenecteplase in combination with enoxaparin, abciximab, or unfractionated heparin: the ASSENT-3 randomised trial in acute myocardial infarction.□□Lancet. Aug. 25, 2001;358(9282):605-13.
Rebello et al. Superiority of Enoxaparin over Heparin in combination with a GPOOb/IIa receptor antagonist during coronary thrombolysis in dogs, 2001, Thrombosis, V. 102, pp. 261-271.
Goodman et al., Randomized trial of low molecular weight heparin (enoxaparin) versus unfractionated heparin for unstable coronary artery disease: one-year results of . . . , J Am Coll Cardiol. Sep. 2000;36(3):693-8.
Cannon, Christopher et al., “TNK-Tissue Plasminogen Activator Compared With Front-Loaded Alteplase in Acute Myocardial Infarction” CIRCULATION 1998; 98 pp. 2805-2814.
Cannon, Christopher et al., “TNK-Tissue Plasminogen Activator in Acute Myocardial Infarction” CIRCULATION, 1997; 95 351-356.
Kawai, Chuichi et al., “A Prospective, Randomized, Double-Blind Multicenter Trial of a Single Bolus Injection of the Novel Modified t-PA E6010 in the Treatment of Acute Myocardial Infarction: Comparison With Native t-PA” JACC v29, No. 7, Jun. 1997, pp. 1447-1453.
Kawasaki, Tomihisa et al., “Thrombolytic Activity of YM866, a Novel Modified Tissue-Type Plasminogen Activator, in a Rabbit Model of Jugular Vein Thrombosis” Drug Development Research 33:33-38 (1994).
Saito, Yoshimasa et al., “Production and Characterization of a Novel Tissue-Type Plasminogen Activator Derivative inEscherichia coli” Biotechnol, Prog. v10, pp. 472-479 (1994).
Schweiger, Marc et al., “Early Coronary Intervention Following Pharmacologic Therapy for Acute Myocardial Infarction” The American Journal of Cardiology, v88 Oct. 2001 pp. 831-836.
Tanswell, Paul et al., “Pharmacokinetics and Fibrin Specificity of Alteplase During Accelerated Infusions in Acute Myocardial Infarction” JACC v19, No. 5, Apr. 1992 pp. 1071-1075.
van de Werf, Frans et al., “Safety assessment of single-bolus administration of TNK tissue-plasminogen activator in acute myocardial infarction: The ASSENT-1 trial” American Heart Journal, v137 No. 5, May 1999.
“Intravenous NPA for the treatment of infracting myocardium early” European Heart Journal, 21, 2005-2013 (2000).
“Efficacy and safety of tenecteplase in combination with enoxaparin, abciximab, or unfractionated heparin: the ASSENT-3 randomised trial in acute myocardial infarction” The Lancet, v358 Aug. 25, 2001 pp. 605-613.
“Single-bolus tenecteplase compared with front-loaded alteplase in acute myocardial infarction: the ASSENT-2 double-blind randomized trial” The Lancet, v354 Aug. 28, 1999, pp. 716-722.
Rawles, J., “Magnitude of benefit from earlier thrombolytic treatment in acute myocardial infarction: new evidence from Grampian region anistreplase trial (GREAT)”,BMJ, 312,:212-215 (1996).
“TI In ASSENT-3 wird das Fibrinolytikum TNK-tPA geprueft”,SO Aerzte-Zeitung0-81,(062) (Apr. 2000) (translation).
“ASSENT 3 Trial Shows Heart Attack Patients May Benefit From New Treatment Regimen: Clot-Buster Plus Low-Molecular-Weight Heparin” Genentech press release Aug. 8, 2001.
“ASSENT-3: implication for future trial design and clinical practice”,European Heart Journal, 23:911-912 (2002).
Hopfner, R, “Lanoteplase Genetics Institute”Current Opinion in Investigational Drug, 1(4):468-475, (Dec. 2000).
Nordt, T. et al., “Pharmacokinetics and Pharmacodynamics of Lanoteplase (n-PA)”,Thromb Haemost, 82 (Suppl.):121-123 (1999).
Verstraete, M., “Newer Thrombolytic Agents”,Annals of Academy of MedicineSingapore 28:424-433 (1999).
den Heijer, P. et al., “Evaluation of a Weight-Adjusted Single-Bolus Plasminogen Activator in Patients With Myocardial Infarction”,Circulation98:2117-2125 (1998).
Jang, I. et al., “A Multicenter, Randomized Study of Argatroban Versus Heparin as Adjunct to Tissue Plasminogen Activator (TPA) in Acute Myocardial Infarction: Myocardial Infarction With Novastan and TPA (MINT) Study”,Journal of the American College of Cardiology33(7):1879-1885 (1999).
Ross, A. et al., “Randomized Comparison of Enoxaparin, a Low-Molecular-Weight Heparin, With Unfractionated Heparin Adjunctive to Recombinant Tissue Plasminogen Activator Thrombolysis and Aspirin”,Circulation, 104 :648-652 (2001).
Antman, E., “Hirudin in Acute Myocardial Infarction Safety Report from the Thrombolysis and Thrombin Inhibition in Myocardial Infaction (TIMI) 9A Trial”,Circulation90(4):1624-1630 (1994).
Antman, E., “Enoxaparin for the Acute and Chronic Management of Unstable Angina”, Supplement I 504 to Circulation 98(17) No. 2649 (1998).
Braunwald, E. “Myocardial Reperfusion, Limitation of Infarct Size, Reduction of Left Ventricular Dysfunction, and Improved Survival”,Circulation79(2):441-444 (1989).
Braunwald, E., “The Open Artery Theory is Alive and Well Again”,NEJM329(22):1650-1652 (1993).
Cannon, C. et al., “GUSTO, TIMI and the case for Rapid Reperfusion”Acta Cardiologica49:1-8 (1994).
Cannon C. et al., “Comparison of Front-Loaded Recombinant Tissue-Type Plasminogen Activator, Anistreplase and Combination Thrombolytic Therapy for Acute Myocardial Infarction: Results of the Thrombolysis in Myocardial Infarction (TIMI) Trial 4”,JACC24(7):1602-1610 (1994).
Cohen, M. et al., “A Comparison of Low-Molecular-Weight Heparin with Unfractionated Heparin for Unstable Coronary Artery Disease”,NEJM37(7):447-452 (1997).
Giugliano, R. et al., “Lower-dose heparin with fibrinolysis is associated with lower rates of intracranial hemorrhage”,Am. Heart J. 141(5):742-750 (2001).
GUSTO IIb Investigators “A Comparison of Recombinant Hirudin with Heparin for the Treatment of Acute Coronary Syndromes”NEJM335(11):775-782 (1996).
GUSTO Angiographic Investigators “The Effects of Tissue Plasminogen Activator, Streptokinase, or Both on Coronary-Artery Patency, Ventricular Function, and Survival After Acute Myocardial Infarction”,NEJM329(22):1615-1622 (1993).
GUSTO Investigators “An International Randomized Trial Comparing Four Thrombolytic Strategies For Acute Myocardial Infarction”,NEJM329(1
Armstrong Paul
Barron Hal
Berioli Silvano
Bigonzi Frederique
Bluhmki Erich
Aventis Pharma S.A.
Boehringer Ingelheim Pharma KG
Boehringer Ingelheim Pharmaceuticals Inc.
Dreger Ginger R.
Genentech Inc.
LandOfFree
Combination treatment with t-PA variant and low molecular... does not yet have a rating. At this time, there are no reviews or comments for this patent.
If you have personal experience with Combination treatment with t-PA variant and low molecular..., we encourage you to share that experience with our LandOfFree.com community. Your opinion is very important and Combination treatment with t-PA variant and low molecular... will most certainly appreciate the feedback.
Profile ID: LFUS-PAI-O-3710621