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Thrombolytic agents and methods of treatment for thrombosis

a technology of thrombosis and thrombolytic agents, which is applied in the field of thrombolytic agents and methods of treatment for thrombosis, can solve the problems of life-threatening, significant patient risk, and long half-life, and achieve the effect of systemic lytic effects and long half-li

Inactive Publication Date: 2005-06-30
BOARD OF RGT UNIV OF NEBRASKA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Thrombosis, the formation and development of a blood clot or thrombus within the vascular system, while a life saving process when it occurs during a hemorrhage, can be life threatening when it occurs at any other time.
When thrombosis occurs without concomitant fibronolysis effects can lead to strokes.
Traditional thrombolytic agents used are not clot specific and while they do break up the thrombus and facilitate fibronolysis they also put the patient at significant risk as all clotting is inhibited and a patient could bleed to death from a small abrasion elsewhere.
Three major problems encountered with the use of streptokinase therapy include its systemic lytic effects coupled with a long half life.
Urokinase is produced by the kidney and as such it is not antigenic and well suited for use if subsequent thrombolytic therapy is needed.
The major problem with urokinase is that it is difficult and expensive to produce precluding its extensive clinical use.
However the results of studies comparing the streptokinase and t-PA show similar incidences of bleeding following administration.
Successful gene cloning has made sufficient quantities of t-PA available for clinical use, however, the recombinant technology necessary for its production have also resulted in a prohibitive cost.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

example 1

In Vitro Clot Lysis Using PESDA and Ultrasound

[0032] The pharmaceutical compositions and method of the invention were shown to reduce the size of blood clots according to the following in vitro protocol. The protocol is known in the art and is predictive of success in vivo Sehgal, “Ultrasound-Assisted Thrombolysis”, Invest-Radiol., October 1993, Vol. 28, No. 10: 939-43. 2 ml aliquots of freshly drawn whole blood were placed into a 10 cc plunger inverted syringes. The blood was then incubated for 2 hours at 37° C. After incubated, the syringes were removed from the water bath and left at room temperature until treatment. Upon treatment the serum was decanted from the clot by pouring the contents of the syringe over a wire mesh screen. The clot was then dried by rolling in the screen and blotting. The clot was then weighed and placed back into the syringe with lytic fluid (microbubble pharmaceutical composition of the invention). Samples without treatment were incubated at 37° C. in ...

example 2

Prophetic

[0039] For humans the anti thrombosis therapy includes doses of the liquid pharmaceutical composition, PESDA, from about as small as 0.0025 up to 0.1 ml / kg given depending on the ultrasonic procedure used. The contrast agent is given by peripheral intravenous infusion over about 1-25 minutes (the dose range is patient specific. Large patients may require slightly higher doses to produce equivalent thrombolysis). Generally in one protocol a patient will receive a 0.01 ml / kg of perfluorocarbon enhanced sonicated dextrose albumin or 0.0015 ml / kg perfluorobutane sonicated dextrose albumin as the initial injection. If this fails to produce significant clot lysis, the dose could then be doubled. Dosing protocols would be similar to those used for ultrasound imaging and are disclosed in Wyman, Arthur E. “Principles and Practice of Echocardiography”, Lee & Febiger, Malvern, Pa. (1994 2nd Edition). Any ultrasound device can be used including the commercially available Hewlett Packa...

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Abstract

The foregoing invention relates to a new microbubble preparation and thrombolytic therapy which relies on microbubbles and ultrasound for its lytic activity. The pharmaceutical composition of the invention comprises a liquid solution of microbubbles with an internal atmosphere enhanced with the perfluorocarbon gas which cavitate in the presence of an ultrasound field following intravenous injection or infusion of said composition into said host. For thrombolysis the area of a thrombus is exposed to an ultrasound field in the presence of the microbubbles and significant lysis is experienced. The method and pharmaceutical composition of the invention exhibit thrombolytic properties similar to those of other thrombolytic agents such as urokinase and are less toxic and are clot specific in that they do not introduce a systemic lytic state to a said animal.

Description

CROSS REFERENCE TO A RELATED APPLICATION [0001] This application is a continuation of Ser. No. 09 / 758,799 filed Jan. 11, 2001, which is a continuation of Ser. No. 09 / 435,050 filed Nov. 8, 1999, which is a continuation of Ser. No. 08 / 832, 532 filed Apr. 3, 1997, which is a divisional of Ser. No. 08 / 544,204 filed Oct. 17, 1995, now U.S. Pat. No. 5,648,098.FIELD OF THE INVENTION [0002] This invention relates to a new and improved pharmaceutical composition and method for treating thrombosis in animals. The methods and composition of the invention can be used as an anticoagulant therapy to induce thrombolysis and to relieve trauma associated with obstruction of smaller vessels. BACKGROUND OF THE INVENTION [0003] Thrombosis, the formation and development of a blood clot or thrombus within the vascular system, while a life saving process when it occurs during a hemorrhage, can be life threatening when it occurs at any other time. The thrombus can block a vessel and stop blood supply to an...

Claims

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Application Information

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IPC IPC(8): A61K9/50A61K31/02A61K41/00
CPCA61K9/5052A61K41/0028A61K31/02
Inventor PORTER, THOMAS R.
Owner BOARD OF RGT UNIV OF NEBRASKA
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