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Methods for treating myeloproliferative disorders

A technique for myeloid hyperplasia and disorders, applied in biochemical equipment and methods, chemical instruments and methods, microbiological determination/inspection, etc., can solve the problem that no drug shows selective anti-clonal effect

Inactive Publication Date: 2018-06-08
PROMEDIOR
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Although a large number of drugs have been developed and evaluated in MF clinical trials, so far no drugs have demonstrated selective anticlonal effects despite activity in alleviating other symptoms

Method used

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  • Methods for treating myeloproliferative disorders
  • Methods for treating myeloproliferative disorders
  • Methods for treating myeloproliferative disorders

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0356] Example 1. Treatment of myelofibrosis with recombinant human SAP (rhSAP)

[0357] Test patients diagnosed with myelofibrosis (including PMF, post-PV MF, or post-ET MF) for baseline mutations in one or more genes such as JAK2, MPL, CALR, ASXL1, EZH2, SRSF2, IDH1, and IDH2 state. To measure the baseline mutation status, a peripheral blood sample is collected from the patient, DNA is extracted from the sample and analyzed by real-time quantitative allele-specific PCR to measure one or more genes such as JAK2, MPL, CALR, Mutation status (ie identification of the presence or absence of one or more mutations) of ASXL1, EZH2, SRSF2, IDH1 or IDH2. Patients received recombinantly expressed human SAP containing α2,3-sialic acid in CHO cells (rhSAP expressed in CHO cells; containing at least one α2,3 linkage and glycosylated differently from SAP derived from human serum SAP; an exemplary SAP protein of the present disclosure). Efficacy was assessed by assessment of myeloid resp...

Embodiment 2

[0358] Example 2. Treatment of myelofibrosis with recombinant human SAP (rhSAP)

[0359] Test patients diagnosed with myelofibrosis (including PMF, post-PV MF, or post-ET MF) for baseline mutations in one or more genes such as JAK2, MPL, CALR, ASXL1, EZH2, SRSF2, IDH1, and IDH2 state. To measure the baseline mutation status, a peripheral blood sample is collected from the patient, DNA is extracted from the sample and analyzed by real-time quantitative allele-specific PCR to measure one or more genes such as JAK2, MPL, CALR, Mutation status (ie identification of the presence or absence of one or more mutations) of ASXL1, EZH2, SRSF2, IDH1 or IDH2. Patients received recombinantly expressed human SAP containing α2,3-sialic acid in CHO cells (rhSAP expressed in CHO cells; containing at least one α2,3 linkage and glycosylated differently from SAP derived from human serum SAP). Efficacy was assessed by assessment of myeloid response rate, defined as a one-step reduction in the WH...

Embodiment 3

[0360] Example 3. Reduction of Mutant Allele Burden in Myelofibrosis Using Recombinant Human SAP (rhSAP)

[0361] Test patients diagnosed with myelofibrosis (including PMF, post-PV MF, or post-ET MF) for baseline mutations in one or more genes such as JAK2, MPL, CALR, ASXL1, EZH2, SRSF2, IDH1, and IDH2 state. To measure the baseline mutation status, a peripheral blood sample is collected from the patient, DNA is extracted from the sample and analyzed by real-time quantitative allele-specific PCR to measure one or more genes such as JAK2, MPL, CALR, Mutation status (ie identification of the presence or absence of one or more mutations) of ASXL1, EZH2, SRSF2, IDH1 or IDH2. Patients with mutations in one or more genes received recombinantly expressed human SAP containing α2,3-sialic acid in CHO cells (rhSAP expressed in CHO cells; contains at least one α2,3 linkage and is glycosylated SAP different from SAP derived from human serum). Doses are adjusted to effectively reduce mu...

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Abstract

In part, the disclosure relates to methods of treating myeloproliferative disorders by administering one or more Serum Amyloid Protein (SAP) proteins. In certain aspects, the method further comprisesmonitoring treatment efficacy by measuring change in mutant allele burden. In certain aspects, the disclosure relates to methods of treating myelofibrosis in patient sub-populations who carry myelofibrosis-associated mutations in some of their cells by administering an SAP protein.

Description

[0001] Cross References to Related Applications [0002] This application claims priority and the benefit of U.S. Provisional Patent Application Serial Nos. 62 / 148,005 (filed April 15, 2015) and 62 / 218,869 (filed September 15, 2015), the disclosure of which is adopted in its entirety incorporated herein by reference. Background technique [0003] Myeloproliferative disorders (MPDs), also known as myeloproliferative neoplasms (MPNs), refer to a group of disorders characterized by clonal abnormalities of blood cells, such as myeloid blood cells and precursors. These disorders may affect myeloid, erythroid, and platelet cells. Myeloproliferative disorders present diagnostic and therapeutic challenges. [0004] In certain proliferative disorders such as myelofibrosis (MF), healthy organ tissue is replaced by fibrosis causing organ insufficiency that contributes to the symptoms of the disorder. Myelofibrosis (including primary myelofibrosis, myelofibrosis after polycythemia vera...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C12Q1/6886A61K38/17
CPCA61K38/202A61K38/13A61K38/1716A61K38/2013A61K38/212A61K9/0019C12Q1/6886C07K2319/00C12Q2600/156C07K14/47A61K45/06A61K31/519A61P19/08A61K2300/00C12Q1/6883
Inventor 伊丽莎白·特雷胡布理查德·M·杰克
Owner PROMEDIOR
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