Methods and compositions for the treatment of autoimmune disorders using clofarabine

Abstract

This invention relates to methods of treating or preventing an autoimmune disorder comprising the administration of clofarabine or a pharmaceutically acceptable salt, hydrate, solvate, clathrate, prodrug or metabolite thereof to a patient in need of such treatment. The invention further relates to methods of treating or preventing an autoimmune disorder comprising the administration of clofarabine or a pharmaceutically acceptable salt, hydrate, solvate, clathrate, prodrug or metabolite thereof and an additional therapeutic agent to a patient in need of such treatment.

Description

1. FIELD OF THE INVENTION [0001] This invention relates to pharmaceutical compositions, dosage forms and dosage regimens utilizing clofarabine. This invention also relates to methods of treating autoimmune disorders, and to methods for dosing clofarabine, each of these methods also encompasses reducing or avoiding undesired effects associated with conventional treatment of autoimmune disorders. 2. BACKGROUND OF THE INVENTION 2.1 Autoimmune Disorders [0002] The immune system is a complicated network of cells and cell components that defend the body and eliminate infections caused by bacteria, viruses, and other invading microbes. Autoimmune disorders, however, cause the immune system to mistakenly attack the cells, tissues, and organs of a patient's own body. [0003] There are many different autoimmune diseases, and they can each affect the body in different ways. Autoimmune disorders can target specific organs and tissues in the body, e.g., the brain, as in Multiple Sclerosis, or the...

AI Technical Summary

Benefits of technology

[0021] As used herein, a “therapeutically effective amount” refers to that amount of the compound of the invention or other active ingredient sufficient to provide a therapeutic benefit in the treatment or management of the disease or to delay or minimize symptoms associated with the disease. Further, a therapeutically effective amount with respect to a compound of the invention means that amount of therapeutic agent alone, or in combination with other therapies, that provides a therapeutic benefit in the treatment or management of the disease. Used in connection with an amount of a compound of the invention, the term can encompass an amount that improves overall therapy, reduces or avoids symptoms or causes of disease, or enhances the therapeutic efficacy of or synergies with another therapeutic agent.

[0028] As used herein, the terms “treat”, “treating” and “treatment” refer to the eradication or amelioration of the disease or symptoms associated with the disease. In certain embodiments, such terms refer to minimizing the spread or worsening of the disease resulting from the administration of one or more prophylactic or therapeutic agents to a subject with such a disease.

Problems solved by technology

Autoimmune disorders, however, cause the immune system to mistakenly attack the cells, tissues, and organs of a patient's own body.

Unfortunately, these medications also suppress the ability of the immune system to fight infection and have other potentially serious side effects.

However, all of the potential uses for clofarabine have thus far remained unexplored or undeveloped.

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