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(12) Patent Application Publication (10) Pub. No.: US 2005/0228001 A1 Hanson (43) Pub US 2005O228001A1 (19) United States (12) Patent Application Publication (10) Pub. No.: US 2005/0228001 A1 Hanson (43) Pub. Date: Oct. 13, 2005 (54) METHODS AND COMPOSITIONS FOR (60) Provisional application No. 60/154,929, filed on Sep. TREATING PLATELET-RELATED 21, 1999. DSORDERS Publication Classification (76) Inventor: Stephen R. Hanson, Beaverton, OR (US) (51) Int. Cl. ................................................ A61K 31/519 Correspondence Address: (52) U.S. Cl. .............................................................. 514/257 FISH & RICHARDSON, PC 12390 EL CAMINO REAL SAN DIEGO, CA 92130-2081 (US) (57) ABSTRACT (21) Appl. No.: 11/127,544 Pharmaceutical preparations comprising one or more agents (22) Filed: May 11, 2005 that reduce the number of circulating platelets to low normal or below normal levels formulated in a delivery system are Related U.S. Application Data provided. The pharmaceutical preparations are useful in the (63) Continuation of application No. 10/603,401, filed on prophylactic and therapeutic treatment of Subjects for the Jun. 25, 2003, which is a continuation of application purpose of inhibiting vaSo-occlusive events, including No. 09/666,223, filed on Sep. 21, 2000, now Pat. No. embolism, by reducing the number of circulating platelets to 6,585,995. low normal to below normal levels. US 2005/0228001 A1 Oct. 13, 2005 METHODS AND COMPOSITIONS FOR TREATING levels of circulating platelets, can unexpectedly derive medi PLATELET-RELATED DISORDERS cal benefit from a reduction in platelet count to below normal levels, without serious adverse consequences as a RELATED APPLICATIONS result of the platelet count reduction. The benefit may be 0001) This application is a continuation of copending proportional or correlative to the reduction in platelet count U.S. patent application Ser. No. 10/603,401, filed Jun. 25, in a broad safety range. Thus in situations where it is 2003, to Stephen R. Hanson, entitled “METHODS AND desirable to inhibit a pathological condition or process COMPOSITIONS FOR TREATING PLATELETRE mediated in part by normal levels of circulating platelets, LATED DISORDERS,” which is a continuation of U.S. Subjects can be treated to lower platelet count preferably to patent application Ser. No. 09/666,223, filed Sep. 21, 2000, a below normal level, thereby inhibiting the development, to Stephen R. Hanson, entitled “METHODS AND COM progression or propagation of the condition or accelerating POSITIONS FOR TREATING PLATELET RELATED or enhancing its regression. The methods of the invention DISORDERS,” now U.S. Pat. No. 6,585,995, which issued are also useful for reducing the incidence of abnormal vessel Jul. 1, 2003, and which claims benefit of priority under 35 growth induced by the presence of platelets. U.S.C. S. 19(e) to U.S. provisional application Ser. No. 0006) A method is provided for treating a subject to 60/154,929 to Stephen R. Hanson, filed Sep. 21, 1999, reduce the risk of developing an adverse condition or to entitled “METHODS AND COMPOSITIONS FOR inhibit the progression and consequences of an adverse TREATING PLATELET RELATED DISORDERS.' The condition mediated at least in part by platelets. In some benefit of priority is claimed to each of these applications. aspects, the Subject is treated to reduce platelet count to low The disclosure of each of these applications is incorporated normal levels, while in other aspects the subject is treated to by reference herein in its entirety. reduce platelet count to below normal levels. In one embodi FIELD OF THE INVENTION ment, the Subject is treated with a pharmaceutical agent. 0002 The invention relates to methods and products for 0007. In one aspect, the invention provides a method for treatment and/or prevention of platelet related thrombotic treating a Subject to inhibit a vaso-occlusive event. Inhibit and other vaso-occlusive disorders. ing a vaso-occlusive event means to prevent the formation of a vaso-occlusive event, to reduce progression and conse BACKGROUND OF THE INVENTION quences of an already established vaso-occlusive event or to 0003 Conditions resulting from thrombotic or throm induce regression of a vaso-occlusive event. The invention boembolic events are the leading causes of illness and death also provides other methods aimed at reducing morbidity or in adults in Western civilization. A great deal of effort and mortality of Subjects from vaso-occlusive events such as but monetary resources have been directed towards understand not limited to thrombotic events which may lead to total or ing the mechanisms involved in vascular occlusive diseases partial vessel blockage by thrombus, or arterial stenosis due involving thrombotic and thromboembolic events. These to excessive cell proliferation. efforts have yielded a number of promising therapeutic agents. Notwithstanding the effort and financial resources 0008 The methods of the invention comprise adminis that have been invested, these conditions still account for the tering to a Subject in need of Such treatment an agent that Vast majority of illness and death in the adult populations of reduces platelet count in the Subject. The agent is adminis developed nations. tered in an amount effective to reduce platelet count in the Subject to at least a low normal level. Such reductions in 0004 Platelets are an important cellular component of platelet count will reduce morbidity and/or mortality and blood involved in hemostasis as well as thrombotic or thereby provide patient outcome benefit. thromboembolic events. Abnormally high platelet counts Such as those that result from hematological proliferative 0009 AS used herein, a vaso-occlusive event includes a disorderS Such as for example essential thrombocythemia pathological partial occlusion (including a narrowing) or have been recognized as an important risk factor in throm complete occlusion of a blood vessel, a stent or a vascular bus formation. Furthermore, it has long been accepted that graft. A vaso-occlusive event intends to embrace thrombotic aspirin, which is known to inhibit cyclooxygenase and and thromboembolic events, and the vascular occlusion thereby prevents production of thromboxane A in platelets, disorders or conditions to which they give rise. Thus, a lowers the incidence of thrombotic and thromboembolic VaSo-occlusive event is intended to embrace all vascular events. For platelets, therapeutic regimens thus far reported occlusive disorders resulting in partial or total vessel occlu have as their aim an inhibition of platelet function (e.g., Sion from thrombotic or thromboembolic events, except inhibition of platelet adhesion, aggregation or factor those that are related to high platelet count due to a hema release). An alternative modality is the reduction in platelet tological proliferative disorder. A thrombotic event as used count in patients with abnormally high levels in certain herein is meant to embrace both a local thrombotic event and hematological malignancies to levels approximating normal a distal thrombotic event (e.g., a thromboembolic event such levels. Therapeutic intervention for reducing platelet count as for example an embolic stroke). A vaso-occlusive event to low normal or below normal levels in subjects without also includes abnormal blood vessel growth induced by the myeloproliferative disorders has not been proposed prima presence of platelets and the factors they secrete. An rily Since normal platelet count has been thought to be example of this latter form of vaso-occlusive event is intimal critical to normal hemostasis. hyperplasia which results in a narrowing of the blood vessels (i.e., reduction in the diameter of blood vessels either locally SUMMARY OF THE INVENTION or throughout an extended segment of the vessel) due to a 0005 The invention in a broad aspect involves the sur hyperproliferation of cells of the intimal layer of the blood prising discovery that Subjects, including those with normal vessel wall. US 2005/0228001 A1 Oct. 13, 2005 0.010 Preferably, the subject is otherwise free of symp 0014. In yet another embodiment, the subject is one who toms calling for treatment with the agent. In Some embodi will undergo an elective Surgical procedure. The agent may ments, the Subject is preferably free of Symptoms associated be administered to Such a Subject prior to the elective with a hematological proliferative disorder Such as for Surgical procedure. The method of the invention can also be example myeloproliferative disease. Preferably, the Subject directed towards a Subject who has undergone a Surgical is a human Subject, but is not So limited. In another embodi procedure. AS used herein, a Surgical procedure is meant to ment, the Subject is apparently healthy. In preferred embodi embrace those procedures that have been classically ments, the Subjects do not have abnormally elevated platelet regarded as Surgical procedures as well as interventional levels (i.e., a platelet count that is higher than the normal cardiology procedures Such as arteriography, angiography, range) that are caused by a hematological proliferative angioplasty and Stenting. Thus, the Surgical procedure, disorder. Thus, preferably, the Subjects do not have a hema whether elective or not, can be Selected from the group tological proliferative disorder. In an important embodi consisting of coronary angiography, coronary Stent place ment, the Subject has a normal platelet count prior to ment, coronary by-pass Surgery, carotid artery procedure, treatment. In Some embodiments, the Subject has a higher
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