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Method for Treatment of Primary Hormone Resistant Endometrial and Breast Cancers

a breast cancer and hormone-resistant technology, applied in the field of primary hormone-resistant endometrial and breast cancer treatment, can solve the problems of no treatment option for patients with recurrent or metastatic endometrial carcinoma, and the depletion of prs in the target tissue of progestin treatmen

Inactive Publication Date: 2017-07-20
LIPOXEN TECHNOLOGIES LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

The present invention provides new methods for treating endometrial and breast cancers that are negative for progesterone receptors (PR) and estrogen receptors (ER). Specifically, the invention provides methods for treating these cancers by administering cridanimod or a salt or ester thereof in combination with a PR agonist or a SERM / SERD, respectively. The methods may result in a complete response (CR), partial response (PR / PR), or stable disease (SD) as per RECIST criteria. The invention also provides pharmaceutical compositions comprising cridanimod or a salt or ester thereof and a PR agonist or a SERM / SERD for the treatment of these cancers.

Problems solved by technology

Currently no therapy of recurrent or metastatic endometrial carcinoma is available to patients.
Unfortunately, progestin treatment leads to depletion of PRs within the target tissue (Satyaswaroop et al., Cancer Lett 1992; 62:107-114).

Method used

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  • Method for Treatment of Primary Hormone Resistant Endometrial and Breast Cancers

Examples

Experimental program
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Effect test

example 1

tion of PR-Agonist and Sodium Cridanimod has Limited Efficacy in Secondary PR-Negative Endometrial Cancer with Acquired Resistance to PR-Agonist but is Highly Effective in Primary PR-Negative Endometrial Cancer

[0095]Eight patients with advanced and metastatic endometrial cancer (FIGO stage III-IV; Mutch. Gynecol Oncol. 2009, 115:325-328) were included to the study. All patients were not amenable for treatment for surgery, chemo- or radiotherapy. Tumor tissue samples from the patients were assessed for PR level. Primary progesterone receptor-negative (PR−) cancer was registered in 3 patients; secondary progesterone receptor-negative (PR−) cancer was registered in 5 patients. All patients were treated with oral PR agonist medroxyprogesterone acetate (MPA) at dose of 500 mg once a day and sodium cridanimod (SC) intramuscular injections at dose of 500 mg twice a week. The responses (complete response, partial response or stable disease) according to RECIST 1.0 (www.recistcom; Therasse e...

example 2

tion of PR-Agonist and Sodium Cridanimod has Significant Antitumor Effect in an Animal Model of Human Primary PR-Negative Endometrial Cancer and Limited Efficacy in an Animal Model of Human Secondary PR-Negative Endometrial Cancer

[0097]In order to confirm the above clinical findings, cridanimod / PR-agonist therapy was tested in animal models of human primary and secondary PR-negative cancers:

[0098]Mouse Model of Primary PR-Negative Endometrial Cancer:

[0099]40 female 8-week-old immunodeficient BNX nu / nu mice (Harlan Laboratories) were bilaterally s.c. injected with 5×106 of human primary PR-negative endometrial cancer cells HEC-1B in 0.1 ml of Matrigel forming two tumors per mouse. Treatment was started on the next day after the injection and discontinued after 5 weeks. Cohorts (10 mice / group) received either:

1) Vehicle control group: vehicle only, 0.9% sodium chloride for injection i.m each alternate day and i.p. for 5 days / week.

2) MA only control group: megestrol acetate (MA) (10 mg...

example 3

tion of Tamoxifen and Sodium Cridanimod is Highly Effective for Treatment of Primary ER-Negative Breast Cancer

[0107]Nine women (48-69 years old) with primary PR / ER-negative (diagnosed using LBA and ICH methods) and HER2 negative (as determined with IHC Dako DakoCytomation's HercepTest), i.e., triple negative breast cancer (TNBC) of stage III-IV not amenable for surgery, chemo- or radiotherapy were treated with tamoxifen (40 mg / day orally) in combination with sodium cridanimod solution injected intramuscularly (i.m.) twice a week at a dose of 500 mg during the first four weeks. After discontinuation of sodium cridanimod, patients continued to take tamoxifen only. The response was assessed each 8 weeks according to RECIST 1.0 criteria (www.recistcom; Therasse et al., J. Natl. Cancer Inst., 2000, 92(3):205-216). The interim results of the trial are shown in Table 4, below.

TABLE 4Patient PR / ER Tamoxifen dailyClinical Progression-free#statusdose, mgeffectperiod, months1Negative20PR82Nega...

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Abstract

The invention provides a method for treatment of primary progesterone receptor-negative (PR−) endometrial cancer comprising administering (i) cridanimod or a salt or an ester thereof and (ii) a progesterone receptor (PR) agonist. The invention further provides a method for treatment of a primary estrogen receptor-negative (ER−) breast cancer, comprising administering (i) cridanimod or a salt or an ester thereof and (ii) a selective estrogen receptor modulator (SERM) or a selective estrogen receptor down-regulator (SERD). Also provided are compositions related to the above methods.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS[0001]This application claims priority to U.S. Provisional Application No. 62 / 076,546, filed on Nov. 7, 2014, the disclosure of which is herein incorporated by reference in its entirety.FIELD OF THE INVENTION[0002]The invention provides a method for treatment of primary progesterone receptor-negative (PR−) endometrial cancer comprising administering (i) cridanimod or a salt or an ester thereof and (ii) a progesterone receptor (PR) agonist. The invention further provides a method for treatment of a primary estrogen receptor-negative (ER−) breast cancer, comprising administering (i) cridanimod or a salt or an ester thereof and (ii) a selective estrogen receptor modulator (SERM) or a selective estrogen receptor down-regulator (SERD). Also provided are compositions related to the above methods.BACKGROUND OF THE INVENTION[0003]Endometrial cancer is one of the most common invasive gynecologic cancers. Currently no therapy of recurrent or metastatic e...

Claims

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Application Information

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IPC IPC(8): A61K31/57A61K31/473
CPCA61K31/473A61K31/57A61K31/135A61K31/138A61K31/40A61K31/565A61K31/58A61K2300/00A61P35/00A61P43/00
Inventor GENKIN, DMITRYSURKOV, KIRILL
Owner LIPOXEN TECHNOLOGIES LTD
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