Method for treating human diseases associated with an increased deoxyribonucleic acid content in extracellular spaces of tissues and a medicinal preparation for carrying out said method

Inventors

Genkin, Dmitry Dmitrievich • Tets, Viktor Veniaminovich • Tets, Georgy Viktorovich

Assignees

CLS Therapeutics Ltd

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Publication Number

US-8871200-B2

Patent

Publication Date

2014-10-28

Expiration Date


Abstract

The invention relates to medicine. The invention provides inventive method for treating human diseases associated with an increased deoxyribonucleic acid content in extracellular spaces of tissues and organs, which method comprises enterally administering DNAse enzyme in a quantity of 20 000-500 000 Kunz units in a day per 1 kg of the body mass. The single dose of the inventive medicinal preparation for treating human diseases associated with an increased deoxyribonucleic acid content in extracellular spaces of tissues and organs comprises 20 000-500 000 Kunz units of the DNAse enzyme. The oral administration of the above-mentioned important doses of the preparation allows the catalytically significant amount of DNAse to be absorbed into the systemic circulation in such a way that the dose-dependent treating effect thereof is exhibited.

Core Innovation

The invention relates to treating a disease in a human associated with increased deoxyribonucleic acid content in extracellular spaces of tissues and organs. The method comprises enterally administering a DNASE I enzyme to a human in need thereof in doses from 20,000 to 500,000 Kunitz units per 1 kg of the body mass per day.

The DNASE I medicinal preparation is introduced as single doses and is suitable for enteral administration, including multiple oral/rectal dosage forms. The documented concept emphasizes that sufficiently high oral doses increase urine DNA-hydrolytic activity and systemic circulation absorption.

The provided in vivo and example data include studies across human conditions associated with extracellular DNA, including oncological disease, EBV infectious mononucleosis, maxillo-facial phlegmona, periodontitis and systemic lupus erythematosus, and age-specific sperm motility impairment.

Claims Coverage

Two independent claims are provided. Both recite enteral administration of a DNASE enzyme to treat a human condition, together with a defined Kunitz-unit daily dose range expressed per 1 kg of body mass, with one claim focused on extracellular DNA-associated diseases and one claim focused on age-specific sperm motility impairment.

Enteral DNASE I treatment for extracellular DNA-associated disease

Treating a disease associated with increased deoxyribonucleic acid content in extracellular spaces of tissues and organs by enterally administering a DNASE I enzyme in doses from 20,000 to 500,000 Kunitz units per 1 kg of the body mass per day.

Enteral DNASE treatment for age-specific sperm motility impairment

Treating age-specific sperm motility impairment in a human by enterally administering a DNASE enzyme in doses from 20,000 to 500,000 Kunitz units per 1 kg of the body mass per day.

Overall, the claim coverage centers on enteral DNASE administration and a defined daily dosing range in Kunitz units per kilogram of body mass to address human disease settings tied to increased extracellular DNA and to treat age-specific sperm motility impairment.

Stated Advantages

Sufficiently high oral doses increase urine DNA-hydrolytic activity and systemic circulation absorption.

Documented Applications

Treating a disease associated with increased deoxyribonucleic acid content in extracellular spaces of tissues and organs in humans, with example data across oncological disease, EBV infectious mononucleosis, maxillo-facial phlegmona, periodontitis and systemic lupus erythematosus, and age-specific sperm motility impairment.

Reducing antibiotic-resistant mutants when microbiology findings are described in combination with rifampicin or gentamycin.

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