Tea catechins in sustained release formulations as cancer specific proliferation inhibitors

Abstract

The invention described herein encompasses a methods and compositions of treating cancer or solid tumors comprising the administration of a therapeutically effective amount of catechins, a group of polyphenols found in green tea, to a mammal in need of such therapy. Compositions of catechins include but not limited to, epigallocatechin gallate (EGCg), epicatechin (EC), epicatechin gallate (ECG), epigallocatechin (EGC). The unique compositions of the invention contain various combinations of the catechins, alone or in combination with each other or other therapeutic agents and are used to treat primary and metastatic cancers in humans. The invention also encompasses the varying modes of administration of the therapeutic compounds, including a sustained release formulation which may be used as a therapeutic compound for the treatment of cancer or as a dietary supplement for the prevention of cancer.

Description

[0001] This is a continuation-in-part of U.S. patent application Ser. No. 09 / 537,211, filed on Mar. 29, 2000, which is incorporated herein, by reference, in its entirety, and which in turn claims benefit to U.S. provisional application serial No. 60 / 126,893 filed Mar. 30, 1999 and U.S. provisional application serial no. 60 / 151,109 filed Aug. 27, 1999.1. INTRODUCTION[0002] The present invention relates to novel methods and sustained release compositions which utilize catechins, including but not limited to, epigallocatechin gallate (EGCg), epicatechin (EC), epicatechin gallate (ECG), and epigallocatechin (EGC), which are found in varying levels in tea leaves. The unique sustained release compositions of the invention contain various amounts of the catechins, including combinations of catechins, or catechins and other therapeutic agents. The invention also encompasses the varying modes of administration of the therapeutic compounds, such as a sustained release formulation which is use...

AI Technical Summary

Benefits of technology

[0030] The disclosure is based, in part, on the discovery that epigallocatechin gallate (EGCg), alone and in combination with other catechins and other anti-cancer therapeutic agents, inhibits the activity of a cancer-specific protein, an isoform of NADH oxidase specific to cancer cells (tNOX). The inhibition of tNOX results in the inhibition of cell growth, and ultimately, apoptosis of the cancer cell, whereas normal cells (which lack tNOX but instead express the isoform CNOX) are less affected. Thus, the invention provides a potent therapeutic effect without or while reducing the adverse effects on normal, healthy cells.

[0035] As used herein, the terms "treating cancer" and "treatment of cancer" mean to inhibit the replication of cancer cells, to inhibit the spread of cancer, to decrease tumor size, to lessen or reduce the number of cancerous cells in the body, and to ameliorate or alleviate the symptoms of the disease caused by the cancer. The treatment is considered therapeutic if there is a decrease in mortality and / or morbidity.

[0041] As used herein, the term "sustained release formulation" refers to any composition that provides slow, controlled, and / or timed release of one or more active ingredients.

Problems solved by technology

However, because of the many variables in lifestyle inherent to such a study, a definitive link between green tea and its cancer prevention effects could not be concluded.

Despite the above studies, the efficacy of EGCg as a single agent therapy for the prevention of cancer is still unclear.

Moreover, the efficacy of EGCg as a therapeutic drug to treat or reverse cancer in a patient is unknown.

Moreover, none of the studies evaluated the efficacy of varying levels of catechin combinations or compositions of multiple catechins for the treatment of cancer.

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