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Method of treating cancer

A prostate cancer, dosage technology, applied in pharmaceutical formulations, medical preparations containing active ingredients, antitumor drugs, etc., can solve problems such as unmet medical needs

Pending Publication Date: 2022-02-22
LAEKNA LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, cross-resistance between the taxanes (docetaxel and cabazitaxel) and the AR targeting agents abiraterone and enzalutamide has recently been reported in the literature, Clinical management of resistant mCRPC patients is even more challenging with current treatment strategies (van Soest et al., Eur J Cancer. 2013; 49(18):3821-30.; Shiota et al., Cancer Sci. 2018; 109(10): 3224-34.doi:10.1111 / cas.13751.)
Therefore, there is a large unmet medical need for the development of new therapies for patients with treatment-resistant mCRPC

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment A

[0153] Example A: Mouse Mini-PDX Model Research

[0154] General Research Design

[0155] The goal of this study was to evaluate the in vivo therapeutic efficacy of CFG920 and afluoroxetine in the MDX191210 Mini-PDX model. The tumor sample was obtained from a 63-year-old male patient diagnosed with abiraterone-resistant prostate cancer.

[0156] animal

[0157] Male Balb / c nude mice were purchased from Nanjing Biomedical Research Institute of Nanjing University (Nanjing, China, SCXK(Su) 2018-0008), certificate: 201806774. Species: House mouse (MusMusculus;); Strain: Balb / c naked; Age: 6 to 8 weeks; Sex: male; Body weight: 20 g to 25 g; Number of animals: 6 mice. Animals had free access to radiation sterilized dry pelleted chow throughout the study period. Animals had free access to sterile drinking water.

[0158] Mice were housed two animals per cage in a specific pathogen-free room at constant temperature and humidity. Captive conditions: temperature: 20°C-26°C; humidi...

Embodiment B

[0179] Example B: Dose Escalation and Efficacy Study of CFG920 and Prednisone Plus Afluoroxetine in Patients with Metastatic Castration-Resistant Prostate Cancer Following Standard of Care Therapy

[0180] overall design

[0181] The Phase I portion of the study was in patients who progressed or were intolerant to any anti-androgen therapy, such as abiraterone, enzalutamide, apalutamide, or any other later approved androgen receptor (AR) antagonist. CFG920 and A dose escalation study of the recommended phase II dose (RP2D) of combination therapy with prednisone + afluxetide. The Phase II portion of the study was initiated after progression or intolerance to any of two prior antiandrogen therapies (as described above) or one of more antiandrogen therapies plus a chemotherapeutic drug selected from docetaxel and cabazitaxel. The preliminary efficacy and safety of the combination therapy of CFG920 and prednisone + afluxerti compared to afuxerbin monotherapy were evaluated in mC...

Embodiment C

[0301] Example C: Summary of the Efficacy and Safety of Combination Therapy of CFG920+Afuroxerti in Human Patients

[0302] One of the objectives of the study in Example B was to evaluate patients in Cohort 1 who received a combination therapy dose of CFG920 75 mg + Prednisone 5 mg BID + Afluxetide 100 mg QD. The patient exhibited anticancer efficacy as assessed by prostate specific antigen (PSA) after receiving the combination therapy of CFG920 + prednisone + afluxerti treatment. The patient's clinical presentation is summarized below in support of this patent application.

[0303] Medical history: This study involved a 79-year-old Caucasian man with a past medical history of atrial fibrillation, hypertension, acid reflux, insomnia, and glaucoma; Lisinopril / Metoprolol, Aluminum Hydroxide / Simethicone, Temazepam, Timolol / Travoprost. He was diagnosed with prostate cancer at the age of 66. She underwent radical prostatectomy shortly after her prostate cancer diagnosis, and des...

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Abstract

The present application provides a method of treating castrate resistant prostate cancer in a patient, comprising administering to the patient a combination of afuresertib and CFG920, wherein the castrate resistant prostate cancer is also resistant to one or more standard of care treatments.

Description

[0001] priority claim [0002] This application claims priority and benefit from International Application Serial No. PCT / CN2019 / 099754 filed on August 8, 2019. The entire contents of the foregoing applications are hereby incorporated by reference. [0003] field of invention [0004] The present disclosure relates to methods of treating cancer and to combinations useful in such treatment. Background technique [0005] Effective treatment of hyperproliferative disorders, including cancer, is a continuing goal of the field of oncology. In general, cancer results from the dysregulation of normal processes controlling cell division, differentiation, and apoptotic cell death and is characterized by the proliferation of malignant cells with the potential for unlimited growth, local expansion, and systemic metastasis. Dysregulation of normal processes includes abnormalities in signal transduction pathways, and / or abnormal regulation of gene transcription, and / or responses to fact...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/573A61K31/4439A61K45/06A61K31/444A61K31/4155A61P35/00A61P35/04
CPCA61K31/573A61K31/4439A61K45/06A61K31/444A61K31/4155A61P35/00A61P35/04A61K2300/00
Inventor 吕向阳张瑞鹏岳勇张敏华
Owner LAEKNA LTD
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