Combination therapy for prostate cancer

A technology for prostate cancer and composition, which can be applied to drug combinations, medical preparations containing active ingredients, pharmaceutical formulations, etc., can solve problems such as inability to effectively and accurately repair DSB, cell death, etc.

Pending Publication Date: 2020-02-04
JANSSEN PHARMA NV
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

If not repaired, DSBs lead to cell death
When PARP inhibitors are used to treat tumor cells with defects in DNA repair involving the HR pathway

Method used

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  • Combination therapy for prostate cancer
  • Combination therapy for prostate cancer
  • Combination therapy for prostate cancer

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0076] Example 1 - Combination Therapy with Patient Evaluation

[0077] Niraparib was supplied as 200 mg capsules or tablets administered orally once daily by patients, abiraterone acetate was supplied as capsules or tablets (4 x 250 mg, total dose 1000 mg) administered orally once daily, and prednisone was administered as tablets Supplied as tablets or capsules (2 x 5 mg), administered orally twice daily (5 mg per tablet, twice daily). Dosing of niraparib was initiated at a starting dose of 200 mg once daily, which is 67% of the current clinical dose of niraparib monotherapy. The dose of abiraterone acetate 1000 mg once daily was kept constant throughout the treatment period, and the dose of prednisone 5 mg twice daily was also kept constant during the treatment period. All drugs were administered together starting on Day 1 of Cycle 1. The medicine must be swallowed whole. Patients took their doses (with or without food) in the morning, except on days when pharmacokineti...

Embodiment 2

[0116] Example 2 - Niraparib Plus Abiraterone Effects on Human Prostate Tumor Model Implanted in Castrated Male Mice (VCaP) Efficacy

[0117] Objective: This study evaluated the efficacy of niraparib in combination with abiraterone in castrated male mice bearing human VCaP prostate tumors. Readouts were tumor volume and survival.

[0118] cell culture

[0119] The human VCaP prostate tumor line was derived from spinal metastases from a patient with castration-resistant prostate cancer. VCaP tumor cells carry TMPRSS2-ERG fusions and express the androgen receptor. VCaP tumor cell lines were maintained in DMEM medium supplemented with 10% fetal calf serum at 37C in an atmosphere of 5% CO2 in air. Tumor cells were subcultured twice weekly by trypsin-EDTA treatment. Cells were harvested for tumor injection when they were in the exponential growth phase.

[0120] Tumor cell injection and study design

[0121] Each mouse was subcutaneously injected with VCaP tumor cells...

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Abstract

Provided are methods and compositions, for treating prostate cancer by administering to a patient in need thereof a therapeutically effective amount of a PARP inhibitor, e.g., niraparib; a therapeutically effective amount of a CYP17 inhibitor, e.g., abiraterone acetate, and a therapeutically effective amount of a glucocorticoid, e.g., prednisone.

Description

technical field [0001] The present disclosure relates to the use of small molecule therapeutics for the treatment of prostate cancer. Background technique [0002] Prostate cancer is the most common non-cutaneous malignancy in men and the second leading cause of cancer-related death in men in the Western world. Prostate cancer results from the uncontrolled growth of abnormal cells in the prostate gland. Once a prostate cancer tumor develops, androgens such as testosterone promote the growth of the prostate cancer. In its early stages, localized prostate cancer is usually cured with local therapies including, for example, surgical resection of the prostate and radiation therapy. However, when local therapy fails to cure prostate cancer, which is not curable in as many as one third of men, the disease progresses to incurable metastatic disease (i.e., disease in which the cancer spreads from one part of the body to another ). [0003] For many years, the established standar...

Claims

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Application Information

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IPC IPC(8): A61K31/454A61K31/573A61K31/58A61P35/00
CPCA61K31/454A61K31/573A61K31/58A61P35/00A61K45/06A61K2300/00
Inventor M.K.于L.A.斯尼德尔
Owner JANSSEN PHARMA NV
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