# US 10,945,961 B2 · Method using enteric-coated etidronate for treating calcification, hypercalcaemia, and calcinosis of the brain and other organs

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- Number: US 10,945,961 B2
- Document ID: US10945961B2
- Status: Granted
- Kind: B2
- Application number: 16/106,346
- Filed: 2018-08-21
- Published: 2019-02-21
- Granted: 2021-03-16
- Earliest claimed: 2017-08-21
- Assignees: Zy Ytherapeutics LLC
- Applicants: Bryan Alan Hill; John Stephan McCarty; Jeffrey Arlin Loeb
- Inventors: Bryan Alan Hill; John Stephan McCarty; Jeffrey Arlin Loeb
- Web page: https://patentgrep.com/patent/US10945961B2

## CPC

- A61K 9/2846: {Poly(meth)acrylates}
- A61B 5/14546: {for measuring analytes not otherwise provided for, e.g. ions, cytochromes}
- A61B 5/4839: {combined with drug delivery}
- A61B 5/4848: {Monitoring or testing the effects of treatment, e.g. of medication}
- A61B 6/501: {for diagnosis of the head, e.g. neuroimaging or craniography}
- A61K 9/0053: {Mouth and digestive tract, i.e. intraoral and peroral administration}
- A61K 9/0056: {Mouth soluble or dispersible forms; Suckable, eatable, chewable coherent forms; Forms rapidly disintegrating in the mouth; Lozenges; Lollipops; Bite capsules; Baked products; Baits or other oral forms for animals}
- A61K 9/4816: {Wall or shell material}
- A61K 9/4891: {Coated capsules; Multilayered drug free capsule shells (with drug coating for immediate release A61K9/4808; osmotic devices A61K9/0004)}
- A61K 9/5026: {obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates}
- A61K 31/663: Compounds having two or more phosphorus acid groups or esters thereof, e.g. clodronic acid, pamidronic acid
- A61P 25/08: Antiepileptics; Anticonvulsants
- G16B 50/00: ICT programming tools or database systems specially adapted for bioinformatics
- G16H 20/10: relating to drugs or medications, e.g. for ensuring correct administration to patients
- G16H 50/20: for computer-aided diagnosis, e.g. based on medical expert systems
- G16H 50/70: for mining of medical data, e.g. analysing previous cases of other patients
- G16H 70/20: relating to practices or guidelines
- G16H 70/40: relating to drugs, e.g. their side effects or intended usage
- A61B 5/002: {Monitoring the patient using a local or closed circuit, e.g. in a room or building (A61B5/0017 takes precedence)}
- A61B 5/021: Measuring pressure in heart or blood vessels
- A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D)
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- G16B: BIOINFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR GENETIC OR PROTEIN-RELATED DATA PROCESSING IN COMPUTATIONAL MOLECULAR BIOLOGY
- G16H: HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA

## Abstract

Among other things, compositions, kits, and methods for epilepsy therapy using a process for treating calcinosis manifested in Neurocysticercosis, Tuberous Sclerosis Complex, and Sturge-Weber Syndrome; an automated platform for real-time diagnosis and treatment of calcinosis comprising a computer-implemented method for using predictive analytics for administering a novel drug, Kamini™, to human patients generated at least in part from information that has been accumulated automatically from on-line resources.

## Claims

### Claim 1

A method for using disodium etidronate for preventing the development of calcifications that could led to neurological symptoms in human patients lacking calcifications, taken from a patient population diagnosed with a condition taken the group consisting of Sturge-Weber Syndrome, Tuber Sclerosis Complex, and Neurocysticercosis, the method comprising:
(a) diagnosing Sturge-Weber Syndrome by means comprising at least one of radiological imaging of leptomeningeal angiomas in the brain, symptom history of Port Wine Birthmark, ocular glaucoma, or tissue genetic testing for GNAQ somatic mutation;
(b) diagnosing Tuber Sclerosis Complex by means comprising at least one of radiological imaging of cortical tubers, subependymal nodules, symptom history of autism spectrum disorder, or genetic testing for gene TSC1 and TSC2 mutations;
(c) diagnosing Neurocysticercosis by means comprising at least one of radiological imaging of cystic brain lesions, positive serology for taenia solium, or travel or living history in endemic regions;
(d) administrating a calcinosis-preventing drug regimen comprising disodium etidronate once or twice daily at a dosage of 2.5 to 20 mg/kg/per day to the diagnosed patients;
(e) monitoring the amount of calcinosis by means of radiological imaging;
(f) obtaining auxiliary medical information of the level of calcinosis by means of symptoms presentation, said symptoms comprising headache, epileptic seizures, behavioral disturbance;
(g) and modifying said calcinosis-preventing drug regimen to ameliorate side effects by means comprising dosage adjustment, drug holiday periods.