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Lopinavir and ritonavir for the treatment of cervix disorders

A Lopina, Cervical technology applied in the field of cancer and disorders, which can solve the problem of low treatment outcomes

Pending Publication Date: 2021-01-08
DOUGLAS PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

While some of these alternative treatment modalities show promise, their treatment outcomes are lower than the reported success rates of 80-95% obtained in quality-assured colposcopy units

Method used

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  • Lopinavir and ritonavir for the treatment of cervix disorders
  • Lopinavir and ritonavir for the treatment of cervix disorders
  • Lopinavir and ritonavir for the treatment of cervix disorders

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 8

[0222] A preferred treatment regimen is described in Example 8.

[0223] Treatment of dysplasia associated with HPV

[0224] In a preferred embodiment of the invention, the pharmaceutical composition is useful for treating a female subject suffering from HPV-associated cervical dysplasia.

[0225] As used herein, "dysplasia" encompasses both preinvasive lesions and cancer. Preinvasive lesions associated with HPV include high-grade squamous intraepithelial lesion (HSIL), atypical squamous cells of undetermined significance (ASCUS), and low-grade squamous intraepithelial lesion (LSIL). Cancers associated with HPV include, for example, cervical intraepithelial neoplasia (CIN) and invasive cervical cancer (ICC).

[0226] The disclosed methods and treatment regimens can be used to treat dysplasia associated with HPV. In some aspects, for example, the disclosed methods and treatment regimens can be used to treat HSIL. In some aspects, the disclosed methods and treatment regimens...

Embodiment 1

[0237] Example 1: Evaluation of the effect of lopinavir:ritonavir at a total API concentration of 20 μM in a ratio of 8:1-16:1 w / w on E6 / E7 immortalized non-transformed endocervical cells

[0238] E6 / E7 endocervical cells are a non-transformed cell line with a phenotype similar to that found in HPV-associated cervical dysplasia. Thus, the cell line represents a good model for evaluating the effects of lopinavir and ritonavir on precancerous and early cancer conditions. For example, dysplasia CIN1-CIN3 associated with HPV.

[0239] 1.1 Method

[0240] 1.1.1 Cell culture

[0241] at 5% CO 2 and 37°C, E6 / E7 cells were maintained by standard methods in RPMI growth medium containing 5% fetal calf serum (FCS).

[0242] Experiments were performed on cells inoculated from T75 confluent starter cultures into T25 flasks. The cells were cultured in T25 flasks for 6 days. Standard culture conditions were followed for the first 3 days, while on days 4-6 the cells were grown in growth...

Embodiment 2

[0252] Example 2: Evaluation of the effect of lopinavir:ritonavir with a total API concentration of 20 μM in a ratio of 8:1-14:1 w / w on HPV18-positive HeLa cervical cancer cells

[0253] The effect of different ratios of lopinavir and ritonavir was evaluated in HeLa cells. HeLa cells, an HPV18-positive cervical cancer cell line, are a good model for HPV-associated malignancies such as invasive cervical cancer (ICC).

[0254] 2.1 Method

[0255] Follow the method described in 1.1, except:

[0256] 2.1.1: The cells were cultured in T25 flasks for 2 days. Standard culture conditions were followed on the first day, while the cells were grown on the second day in growth medium without FCS.

[0257] 2.1.2: Culture was continued for 2 days in RPMI growth medium containing 5% FCS and a total API concentration of 20 μΜ with lopinavir and ritonavir in the ratios stated in the results section.

[0258] 2.2 Results

[0259] Fig. 2 (A) shows with DMSO (control); 20 μ M lopinavir alone...

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Abstract

The present invention concerns pharmaceutical compositions formulated for topical application that are useful in the treatment of HPV-related pathologies and in particular the treatment of premalignant and malignant conditions of the cervix. The compositions comprise a therapeutically effective amount of lopinavir and ritonavir in a pharmaceutically acceptable vehicle and wherein the weight ratio(w / w) of lopinavir: ritonavir is between 9:1 and 18:1.

Description

technical field [0001] Provided herein are methods and compositions for treating and / or inhibiting the development or progression of cancers and benign proliferative disorders of the cervix, particularly such cancers and disorders caused by human oncoviruses such as human papillomavirus (HPV). In particular, there is provided a composition comprising lopinavir and ritonavir for use in treating and / or inhibiting the progression of HPV-associated cervical dysplasia. Background technique [0002] There are many different forms of cancer, and the disease is believed to have many different causes. Cancer rates vary, but in most developed countries it is the second leading cause of death after heart disease. Current estimates suggest that one in three currently living Americans will develop some form of cancer. It is well known that there is a need to develop new and improved therapies for the treatment of cancer. In addition, there is a need to develop therapeutic agents that ...

Claims

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Application Information

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IPC IPC(8): A61K31/427A61K31/513A61P35/00
CPCA61K31/513A61K31/427A61P35/00A61K2300/00A61P15/02A61K9/0034A61K9/06A61K47/38
Inventor 伊恩·汉普森琳妮·汉普森
Owner DOUGLAS PHARMA
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