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Interleukin-11 compositions and methods of use

A technology of interleukin and composition, which is applied in the pharmaceutical composition for preventing and/or treating thrombocytopenia, and relieves the field of individual thrombocytopenia, which can solve the problems of enhancing, limiting beneficial effects, increasing cancer incidence and mortality, etc.

Inactive Publication Date: 2008-12-10
WYETH LLC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Diagnosing thrombocytopenia in cancer patients is often complicated by the fact that such patients are often treated with multiple drugs and may also receive methods that enhance the toxicity of these drugs
Thus, drug-induced thrombocytopenia limits the beneficial effects of chemotherapy on potentially curable malignancies by preventing proper administration of drugs at optimal doses and regimens, which may lead to increased cancer morbidity or even mortality

Method used

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  • Interleukin-11 compositions and methods of use
  • Interleukin-11 compositions and methods of use
  • Interleukin-11 compositions and methods of use

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0166] Example 1: Effect of IL-11 on CMC-544-Induced Thrombocytopenia in Nude Mice

[0167] experimental design:

[0168] In this example it is shown that IL-11( ) on CMC-544-induced thrombocytopenia. Initial IL-11 dosing was daily intraperitoneal administration (250 μg / kg) starting two days before CMC-544 administration, or twice daily (125 μg / kg) starting 8 hours after CMC-544 administration (considered day 0) . IL-11 was administered daily for 8 days after CMC-544 administration. Mice were bled on day 0 to obtain baseline platelet values ​​and then either vehicle or CMC-544 was administered ip at 4 μg per mouse. Higher or lower doses of CMC-544 were also administered. Blood samples were taken at various time points 3 days after drug administration.

[0169] method:

[0170] A 25-gauge needle was inserted into the tail vein of the mouse and then withdrawn to allow the blood droplet to ooze out. A 5 μL blood sample was collected for analysis. Platelet values ​​were ...

Embodiment 2

[0172] Example 2: Effect of IL-11 on CMC-544-induced Thrombocytopenia in Monkeys

[0173] A - first study

[0174] Test design:

[0175] On day -9, blood was taken from 10 monkeys (cynomolgus monkeys) from which 8 monkeys with more normal blood values ​​were selected for the study. The selected monkeys were divided into 2 groups, 4 in each group. A group of test monkeys were pre-administered IL-11 for 5 days before receiving CMC-544. Another group of monkeys (or control monkeys) is administered a sterile saline vehicle control. This provides an appropriate control for the stress involved in administering IL-11 to monkeys in order to differentiate potential vehicle and / or IL-11 side effects (i.e. effects on blood or hematological parameters), should they occur . Both groups received CMC-544 on Day 1. IL-11 was administered to the test group on the day of CMC-544 administration, and continued for 4 days. The test group received a total of 10 doses of IL-11. Both groups o...

Embodiment 3

[0219] Example 3: Effect of calicheamicin conjugates on platelet levels in mice

[0220] experimental design:

[0221] On day 0, mice were bled to obtain baseline platelet values. Mice were then administered vehicle, CMC-544 or other calicheamicin conjugates intravenously or intraperitoneally (4 μg per mouse). Higher or lower dosages may also be administered. Blood samples were taken at 72 hours (Day 3), 96 hours (Day 4) and 168 hours (Day 8) after drug administration.

[0222] method:

[0223] A 25-gauge needle was inserted into the tail vein of the mouse and then withdrawn to allow the blood droplet to ooze out. A 5 μL blood sample was collected for analysis. Blood was sampled on day 0 before drug administration, and on days 3, 4, and 8, for a total of 4 collections of 5 μL each (20 μL in total).

[0224] Dosing: CMC-544 or other calicheamicin conjugates were administered once at a dose of 4 μg calicheamicin DMH intraperitoneally or intravenously. The dose volume for an...

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Abstract

The present invention provides methods for the treatment and / or prevention of thrombocytopenia including thrombocytopenia associated with drug-induced liver damage and thrombocytopenia associated with drug-induced bone marrow destruction. The methods of treatment of the invention include administration of interleukin-11 to a subject suffering from or susceptible to thrombocytopenia and / or receiving or about to receive a treatment involving a conjugate therapeutic agent whose administration results in thrombocytopenia. Also provided are pharmaceutical compositions and kits useful for carrying out such methods of treatment.

Description

[0001] related application [0002] This application claims priority to Provisional Application No. 60 / 742,658, filed December 6, 2005, and Provisional Application No. 60 / 842,294, filed September 5, 2006, both entitled "Interleukin-11 Combination substances and methods of use”. Each provisional application is hereby incorporated by reference in its entirety. Background of the invention [0003] Platelets are important for maintaining hemostasis and initiating clot formation at the site of injury. Platelets also release growth factors at the site of clot formation that speed up the healing process, one of several functions. In patients with reduced levels of platelets, a condition known as thrombocytopenia, the inability to form blood clots is the most immediate consequence. Severe thrombocytopenia results in a typical pattern of bleeding: multiple petechiae in the skin, usually most prominent on the calf; scattered small petechiae over minor trauma; bleeding from the mucous...

Claims

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Application Information

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IPC IPC(8): A61K38/20A61K47/48A61P35/00A61K47/68
Inventor N·K·达姆尔J·迪约瑟夫P·F·尚德尔
Owner WYETH LLC
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