# US 10,307,450 B2 · Method of treating neurological conditions with extract of Nerium species or Thevetia species

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- Number: US 10,307,450 B2
- Document ID: US10307450B2
- Status: Granted
- Kind: B2
- Application number: 15/704,212
- Filed: 2017-09-14
- Published: 2018-02-15
- Granted: 2019-06-04
- Earliest claimed: 2010-01-11
- Assignees: Phoenix Biotechnology, Inc.
- Applicants: Phoenix Biotechnology, Inc.
- Inventors: Otis C. Addington; Robert A. Newman
- Web page: https://patentgrep.com/patent/US10307450B2

## CPC

- A61K 36/24: Apocynaceae (Dogbane family), e.g. plumeria or periwinkle
- A61K 31/19: Carboxylic acids, e.g. valproic acid (salicylic acid A61K31/60)
- A61K 31/56: Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
- A61K 31/704: attached to a condensed carbocyclic ring system, e.g. sennosides, thiocolchicosides, escin, daunorubicin {(digitoxin A61K31/7048)}
- A61K 31/7048: having oxygen as a ring hetero atom, e.g. leucoglucosan, hesperidin, erythromycin, nystatin {, digitoxin or digoxin}
- A61K 45/06: Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
- 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)

## Abstract

A method of treating neurological condition in a subject by administration of a neuroprotective composition of a mixture of two or more triterpenes. Alzheimer's disease, Huntington's disease, stroke or Parkinson's disease are treated by administering a therapeutically effective amount of the neuroprotective composition to a subject.

## Claims

### Claim 1

A method of treating a neurological disorder, condition or disease, the method comprising administering a therapeutically effective amount of a neuroprotective composition consisting essentially of oleanolic acid (O), ursolic acid (U) and betulinic acid (B) as the primary or sole pharmacologically active ingredients, wherein:
a) the neuroprotective composition excludes cardiac glycoside, and excludes pharmacologically active polysaccharide obtained from Nerium species or of Thevetia species; and
b) the O, U and B are independently selected upon each occurrence from the free acid form, salt form, derivative form, prodrug form or a combination thereof.

### Claim 2 (depends on 1)

The method of claim 1, wherein 0.5-10 mg of O per kg of body weight, 1-6.5 mg of U per kg of body weight, and 1-3.5 mg of B per kg of body weight are administered per day.

### Claim 3 (depends on 1)

The method of claim 1, wherein the neurological condition is a neurological disease or disorder having an etiology associated with altered Na,K-ATPase activity.

### Claim 4 (depends on 1)

The method of claim 1, wherein the neurological condition is a neurological disease or disorder having an etiology associated with altered HIF-1α activity.

### Claim 5 (depends on 1)

The method of claim 1, the molar amount of U exceeds the molar amount of B.

### Claim 6 (depends on 1)

The method according to claim 1, wherein the neurological condition is selected from the group consisting of amyotrophic lateral sclerosis, bovine spongiform encephalopathy, multiple sclerosis, diabetic neuropathy, autism and juvenile neuronal ceroid lipofuscinosis.

### Claim 7 (depends on 1)

The method of claim 1, wherein the molar amount of O exceeds the molar amount of U.

### Claim 8 (depends on 1)

The method of claim 1, wherein the molar ratio of O:U is about 4-2 O:3-1 U, or about 3-3.5 O:about 2-2.5 U, or about 3 O: about 2 U, or about 3.2 O:about 2.3 U, or about 7.8 O:about 7.4 U, or about 0.8-1.2 O:1.2-0.8 U, or about 7-8 O:about 7-8 U, or about 7.5 O:about 7.7 U, or about 4-2 O:0.1-1.5 U, 3-3.5 O:about 0.8-1.2 U, or about 3 O:1 U, or about 3.2 O: about 1 U, or about 7.8 O:about 1 U, or about 7-8 O:1.2-0.8 U, or about 7-8 O:about 1.1-0.9 U, or about 7-8 O:about 1 U.

### Claim 9 (depends on 1)

The method of claim 1, wherein the molar amount of O exceeds the molar amount of B.

### Claim 10 (depends on 1)

The method of claim 1, wherein the molar ratio of O:B is about 4-2 O:3-1 B, or about 3-3.5 O:about 2-2.5 B, or about 3 O:about 2 B, or about 3.2 O:about 2.3 B, or about 7.8 O:about 7.4 B, or about 0.8-1.2 O:1.2-0.8 B, or about 7-8 O:about 7-8 B, or about 7.5 O:about 7.7 B, or about 4-2 O:0.1-1.5 B, 3-3.5 O:about 0.8-1.2 B, or about 3 O:1 B, or about 3.2 O:about 1 B, or about 7.8 O:about 1 B, or about 7-8 O:1.2-0.8 B, or about 7-8 O:about 1.1-0.9 B, or about 7-8 O:about 1 B.

### Claim 11 (depends on 1)

The method of claim 1, wherein the molar amount of O exceeds the molar amount of U or B.

### Claim 12 (depends on 11)

The method of claim 11, wherein the molar ratio of O:U:B is about 4-2 O:3-1 U:0.1-1.5 B, or about 3-3.5 O:about 2-2.5 U:about 0.8-1.2 B, or about 3 O:2 U:1 B, or about 3.2 O:about 2.3 U:about 1 B, or about 7.8 O:about 7.4 U:about 0.8-1.2 B, or about 7-8 O:about 7-8 U:about 0.8-1.2 B, or about 7.8 O:about 7.4 U:about 0.9-1.1 B, or about 7.8 O:about 7.4 U:about 1 B.

### Claim 13 (depends on 1)

The method of claim 1, wherein the neurological condition is selected from the group Alzheimer's disease, Huntington's disease, stroke, and Parkinson's disease.

### Claim 14 (depends on 1)

The method according to claim 1, wherein the neuroprotective composition is administered on a recurring basis daily, every other day, every second day, every third day, every fourth day, every fifth day, every sixth day, weekly, every other week, every second week, every third week, monthly, bimonthly, semi-monthly, every other month every second month, quarterly, every other quarter, trimesterly, seasonally, semi-annually, or annually.

### Claim 15 (depends on 1)

The method according to claim 1, wherein the neuroprotective composition is administered one or more times in a day.

### Claim 16 (depends on 1)

The method of claim 1, wherein the method is a time-delayed method of treating stroke in subject, the method comprising:
within an acceptable delay period after said subject has suffered the stroke, administering said neuroprotective composition in an amount sufficient to treat said stroke.

### Claim 17 (depends on 16)

The method of claim 16, wherein the delay period is 10 hours to less.

### Claim 18 (depends on 16)

The method of claim 16, wherein the stroke is ischemic stroke or stroke-mediated ischemic brain injury.