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Nanoliposomal irinotecan for use in treating small cell lung cancer

A technology for small cell lung cancer and tecan, applied in liposome delivery, medical preparations containing active ingredients, inorganic active ingredients, etc.

Inactive Publication Date: 2019-04-16
IPSEN BIOPHARM LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

To date no targeted therapy has succeeded in significantly improving patient outcomes

Method used

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  • Nanoliposomal irinotecan for use in treating small cell lung cancer
  • Nanoliposomal irinotecan for use in treating small cell lung cancer
  • Nanoliposomal irinotecan for use in treating small cell lung cancer

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0105] Embodiment 1: liposomal irinotecan

[0106] The liposomal irinotecan composition preferably comprises or consists of phosphatidylcholine, cholesterol and polyethylene glycol derivatized phosphatidylethanolamine. Liposome irinotecan may comprise a unilamellar lipid bilayer vesicle comprising phosphatidylcholine and cholesterol thereby encapsulating irinotecan sucrose octasulfate. The diameter of irinotecan liposomes in the liposomal irinotecan composition was 110 nm (±20%). Liposome irinotecan may comprise irinotecan sucrose octasulfate encapsulated in liposomes having a unilamellar lipid bilayer vesicle approximately 110 nm in diameter encapsulating Aqueous space of irinotecan as sucrose octasulfate salt in gelled or precipitated state; in which vesicles are composed of: 1,2-distearoyl-sn-glyceryl-3-phosphocholine (DSPC ) (eg, about 6.8 mg / mL), cholesterol (eg, about 2.2 mg / mL), and methoxy-terminated polyethylene glycol (MW 2000)-distearoylphosphatidylethanolamine (M...

Embodiment 2

[0111] Topoisomerase I inhibition has potent effects on a broad range of cancer cell lines. Reference data are available in the Wellcome Trust Sanger Institute database for the Genomics of Drug Sensitivity in Cancer program for 663 cancer cell lines screened for sensitivity to SN-38 (URL www.cancerrxgene.org / translation / Drug / 1003). Analysis of this data indicates that SCLC cell lines have similar sensitivity to SN-38 as pancreatic and gastrointestinal cancer cell lines ( figure 1 ). In this dataset, cancer cell lines of gastrointestinal (HT-29, HCT-116, LoVo, MKN45) or pancreatic (AsPC-1, BxPC3, CFPAC-1, MiaPaCa-2) origin are highlighted by solid circles, for these Significant in vivo antitumor efficacy of MM-398 was observed in cancer cell lines. SCLC cell lines DMS114 and NCI-H1048 (see below) are also shown as solid circles.

[0112] The activity of the active metabolite SN-38 of irinotecan against various SCLC cell lines was studied in in vitro growth and viability ass...

Embodiment 3

[0114] The activity of MM-398 as a single agent was studied in a xenograft model of SCLC. DMS114 cells were inoculated subcutaneously in NCR nu / nu mice. When the tumor volume reaches about 300mm 3 , the mice were treated with 10 or 20 mg / kg of MM-398 irinotecan hydrochloride administered intravenously once a week for 4 weeks. Based on PK modeling and comparison with clinical PK data, a dose level corresponding to the dose considered to be clinically relevant in mice is selected. Such as image 3 As shown, antitumor activity was seen at all dose levels tested in the DMS114 model. Animals with tumors receiving 10 or 20 mg / kg showed tumor regression that persisted approximately 20-27 days after the last dose of MM-398 (2 / 5 and 4 / 5 at 10 and 20 mg / kg, respectively. 5 completely disappeared).

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Abstract

Novel therapies for the treatment of small cell lung cancer (SCLC) include the administration of an antineoplastic therapy consisting of liposomal irinotecan administered once every two weeks, optionally including the administration of other non-antineoplastic agents to the patient such as the administration of a corticosteroid and an anti-emetic to the patient prior to the administration of the irinotecan liposome.

Description

[0001] related application [0002] This application claims U.S. Provisional Application No. 62 / 337,961 (filed May 18, 2016), U.S. Provisional Application No. 62 / 345,178 (filed June 3, 2016), U.S. Provisional Application No. 62 / 362,735 (filed July 15, 2016) filed), U.S. Provisional Application No. 62 / 370,449 (filed August 3, 2016), U.S. Provisional Application No. 62 / 394,870 (filed September 15, 2016), U.S. Provisional Application No. 62 / 414,050 (filed October 28, 2016) U.S. Provisional Application No. 62 / 415,821 (filed Nov. 1, 2016), U.S. Provisional Application No. 62 / 422,807 (filed Nov. 16, 2016), U.S. Provisional Application No. 62 / 433,925 (filed Dec. 14), U.S. Provisional Application No. 62 / 455,823 (filed February 7, 2017), and U.S. Provisional Application No. 62 / 474,661 (filed March 22, 2017), each of which Incorporated herein by reference in its entirety. technical field [0003] The present invention relates to the treatment of patients diagnosed with small cell lung...

Claims

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Application Information

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IPC IPC(8): A61K31/4745A61P35/00A61K9/127
CPCA61K9/127A61K31/4745A61P35/00A61K31/573A61K9/0019A61K45/06A61K2300/00A61K33/243
Inventor B·阿迪维加亚J·B·菲茨杰拉德H·李
Owner IPSEN BIOPHARM LTD
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