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Methods for predicting drug responsiveness in cancer patients

A cancer and pharmacy technology that can be used in biochemical equipment and methods, drug combinations, drug delivery, etc., to solve problems such as missing critical opportunities

Pending Publication Date: 2021-01-29
亚拉勒提治疗欧洲私人有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] In cancer treatment, critical moments are often missed due to the trial and error approach used to find effective therapies

Method used

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  • Methods for predicting drug responsiveness in cancer patients
  • Methods for predicting drug responsiveness in cancer patients
  • Methods for predicting drug responsiveness in cancer patients

Examples

Experimental program
Comparison scheme
Effect test

example 1

[0556] Example 1. Identification of biomarkers of sensitivity and resistance to 2X-121.

[0557] A panel of the NCI60 cell line can be used to determine sensitivity to 2X-121, but other cell line panels can also be used. Here we used the panel of 74 cell lines shown in Table 1.

[0558] Table 1. Measured growth inhibition (IC50 in [mu]M) of cell lines treated with 2X-121.

[0559]

[0560]

[0561]

[0562]

[0563] The 61 cancer cell lines in Table 1 (excluding M14 HEC-1 ECC-1 SNG-11 HEC-88nu SR IM-9 Namalwa MC / CAR U266 JVM-13NCEB- 1 ARH-77) baseline DNA chip. For each array, a logit transformation was performed followed by a Z-transformation so that the mean was zero, SD was 1, and the logit transformation was associated with growth inhibition (-log(GI50)). The expression level of each gene of Table 2 and Table 3 in each cell line correlated with the growth (log(GI50)) of these cell lines in the presence of 2X-121. Pearson correlation coefficients were determ...

example 2

[0583] Example 2. Clinical proof-of-concept study.

[0584] A phase I trial of 2X-121 was conducted in the United Kingdom (clinicaltrial.gov number NCT01618136). The daily oral dose of 2X-121 is 50-800 mg. Of the 41 patients enrolled in the Phase I clinical trial, 35 were evaluated for response. Among them, 2 cases had partial response (PR) (overall response rate (ORR) 5%), and 13 cases had stable disease (SD). Biopsy and BRCA analysis were voluntary and available from 16 and 7 patients, respectively. figure 2 is a waterfall plot showing the change from baseline tumor diameter for 16 patients who underwent biopsy.

[0585] Of the 16 biopsy patients, 13 passed quality control (QC) in our laboratory and were assayed on the Affymetrix HG-U133Plus2 array. Table 4 shows 13 patients.

[0586] A statistical analysis plan was completed prior to blinded prediction of 2X-121 sensitivity on 13 samples. In this analysis, for each patient, the difference in the mean expression of th...

example 3

[0609] Example 3. Predicting breast cancer patient responsiveness to 2X-121 or a pharmaceutically acceptable salt thereof.

[0610] The diagnostic methods described herein can be used to predict the responsiveness of breast cancer patients to treatment with 2X-121 or a pharmaceutically acceptable salt thereof. Specifically, the breast cancer patient may be a patient who has not received any cancer treatment before, or a patient who has received cancer treatment other than 2X-121 or a pharmaceutically acceptable salt thereof. Still further, the patient can be a patient diagnosed with breast cancer or suffering from recurrence of breast cancer.

[0611] A biological sample (eg, a breast tissue sample such as obtained by biopsy) can be obtained from a patient by methods well known in the art. The sample can be frozen and / or prepared by, for example, formalin fixation and paraffin embedding. Specifically, for one or more of the biomarkers shown in Table 2 and / or Table 3, mRNA ca...

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Abstract

The present invention features methods, devices, and kits for detecting gene expression in a patient with a cancer or determining responsive of a patient with a cancer to a treatment, such as treatment with 2X-121 or a pharmaceutically acceptable salt thereof. The invention further includes methods of treating a patient with a cancer by administering a treatment, e.g., treatment with 2X-121 or a pharmaceutically acceptable salt thereof, in particular when the patient is determined to be responsive to the treatment based on the expression of the biomarkers described herein.

Description

technical field [0001] Biomarkers are used to predict a subject's responsiveness to cancer therapy. Background technique [0002] DNA microarrays have been used to measure gene expression in patient tumor samples to facilitate diagnosis. In addition to type, stage and origin, gene expression can reveal the presence of cancer in a patient. Gene expression may even play a role in predicting the efficacy of cancer therapies. In recent decades, the National Cancer Institute (NCI) has tested cancer therapeutics in limiting the growth of 60 human cancer cell lines. NCI also measured the gene expression of these 60 cancer cell lines using DNA microarrays. Various studies have explored the relationship between gene expression and treatment efficacy using NCI datasets. [0003] During the course of cancer treatment, critical moments are often missed due to the trial and error approach used to find effective therapies. In addition, cancer cells often develop resistance to previou...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C12Q1/6886A61P35/00
CPCA61P35/00C12Q1/6886C12Q2600/106C12Q2600/158A61K9/0053A61K31/519A61K45/06
Inventor S·克努森
Owner 亚拉勒提治疗欧洲私人有限公司
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