# US 2013/0252902 A1 · Type a2 botulinum toxin preparation

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- Number: US 2013/0252902 A1
- Document ID: US20130252902A1
- Status: Published application
- Kind: A1
- Application number: 13/903,731
- Filed: 2013-05-28
- Published: 2013-09-26
- Earliest claimed: 2008-03-31
- Assignees: The Chemo-Sero-Therapeutic Research Institute
- Inventors: Shinji NAKAHIRA; Yasushi Torii; Yoshitaka Goto; Miho Shinmura; Satomi Munechika; Sachio Okuda; Shunji Kozaki
- Web page: https://patentgrep.com/patent/US20130252902A1

## CPC

- A61K 38/164: {from bacteria}
- A61K 38/4893: {Botulinum neurotoxin (3.4.24.69)}
- A61P 21/00: Drugs for disorders of the muscular or neuromuscular system
- A61P 21/02: Muscle relaxants, e.g. for tetanus or cramps
- Y02A 50/30: Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change
- 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)
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- Y02A: TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE

## Abstract

A method for treating a patient who has a neutralizing antibody to a type A1 botulinum toxin. The method includes administering 150 kDa type A neurotoxin from type A2 Clostridium botulinum (A2 NTX) to the patient. In accordance with the present invention, a problem can be solved of decrease in clinical response caused by a neutralizing antibody to a type A1 botulinum toxin produced when a patient is treated with a pharmaceutical preparation containing a type A1 botulinum toxin.

## Claims

### Claim 1

A method for treating a patient who has a neutralizing antibody to a type A1 botulinum toxin, said method comprising administering A2 NTX to the patient.

### Claim 2

A method for treating a patient suffering from a disease with muscle overactivity who has a neutralizing antibody to a type A1 botulinum toxin, said method comprising administering A2 NTX to the patient.

### Claim 3 (depends on 1)

The method of claim 1, wherein the administering is topical.

### Claim 4 (depends on 1)

The method of claim 1, wherein the administering is intramuscular.

### Claim 5 (depends on 4)

The method of claim 4, wherein a dose administered is 0.01 to 2000 units, wherein one unit is a mouse LD50 amount of A2 NTX.

### Claim 6 (depends on 4)

The method of claim 4, wherein a dose administered is 0.5 to 600 units, wherein one unit is a mouse LD50 amount of A2 NTX.

### Claim 7 (depends on 2)

The method of claim 2, wherein the disease with muscle overactivity is selected from the group consisting of strabismus, blepharospasm, hemifacial spasm, spasmodic torticollis, post-stroke apasticity, cerebral palsy, spasmodic dysphonia, migraine headache, lumbago, shoulder stiffness, paresis occurring at onset of Parkinson's disease, paresis occurring at onset of multiple sclerosis, myofascial pain syndrome, spasm of a masticatory muscle, chronic anal fissure, overactive bladder, bruxism, facial myokymia, tic, local dystonia, and wrinkle.

### Claim 8 (depends on 1)

The method of claim 1, wherein the A2 NTX is administered as a mixture comprising the A2 NTX and a stabilizing agent.

### Claim 9 (depends on 8)

The method of claim 8, wherein the stabilizing agent is a human serum albumin.

### Claim 10 (depends on 8)

The method of claim 8, wherein the mixture comprises a final concentration of 0.1 to 5 mg/ml of the stabilizing agent.

### Claim 11 (depends on 8)

The method of claim 8, wherein the mixture comprises a final concentration of 0.5 to 2 mg/ml of the stabilizing agent.

### Claim 12 (depends on 9)

The method of claim 9, wherein the mixture comprises a final concentration of 0.1 to 5 mg/ml of the stabilizing agent.

### Claim 13 (depends on 9)

The method of claim 9, wherein the mixture comprises a final concentration of 0.5 to 2 mg/ml of the stabilizing agent.

### Claim 14 (depends on 8)

The method of claim 8, wherein the mixture further comprises a solvent selected from the group consisting of distilled water, physiological saline, and 0.01 M to 0.1M of a phosphate buffer.

### Claim 15 (depends on 9)

The method of claim 9, wherein the mixture further comprises a solvent selected from the group consisting of distilled water, physiological saline, and 0.01 M to 0.1M of a phosphate buffer.

### Claim 16 (depends on 14)

The method of claim 14, wherein the mixture further comprises ethanol or glycerol.

### Claim 17 (depends on 15)

The method of claim 15, wherein the mixture further comprises ethanol or glycerol.

### Claim 18 (depends on 8)

The method of claim 8, wherein the mixture has a pH of 3 to 8.

### Claim 19 (depends on 8)

The method of claim 8, wherein the mixture has a pH of 4 to 7.

### Claim 20 (depends on 8)

The method of claim 8, wherein the mixture has a pH of 5 to 7.