IP Library Granted Patent US 9,278,133
Granted Patent B2
US 9,278,133 · App. 12/447,351 · Granted Mar 8, 2016

Highly purified type A

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Quick Facts
Patent No.
US 9,278,133
App. No.
12/447,351
Granted
Mar 8, 2016
Kind
B2
Abstract

A novel type A botulinum toxin preparation is provided. A neuromuscular transmission blocking agent comprising as an active ingredient a highly purified type A botulinum toxin from Clostridium botulinum as infant botulism pathogen and a medicament for treating a disease with a muscle overactivity comprising as an active ingredient said toxin. In particular, the medicament of the present invention, as compared to the conventional known botulinum toxin preparations, has rapid efficacy of potential and is less diffusive and thus, having a broader safety margin, may be used as therapeutic medicament for decreasing local, muscle overactivity in a disease with a muscle overactivity.

Claims (11)

1. A neuromuscular transmission blocking agent, comprising, as an active ingredient, a highly purified botulinum toxin type A S toxin (NTX), an active center protein, that is from hemagglutinin-non-producing Clostridium botulinum type A isolated as infant botulism pathogen, that is not in a complex with a non-toxic protein (NTNH), and that does not comprise hemagglutin (HA) proteins, wherein said botulinum toxin type A S toxin (i) has a molecular weight of 150 kDa and (ii) has a broader therapeutic window, a broader safety margin, and exhibits a more rapid efficacy and a less diffusive property than botulinum toxins LL, L and M.

2. The neuromuscular transmission blocking agent of claim 1 , wherein said highly purified botulinum toxin type A is produced by any HA-negative strain of Kyoto-F, Chiba-H, Y-8036, 7I03-H, 7I05-H, or KZ1828 derived from infant botulism pathogen.

3. The neuromuscular transmission blocking agent of claim 1 , which further comprises a stabilizing agent for botulinum toxin.

4. The neuromuscular transmission blocking agent of claim 3 , wherein said stabilizing agent is a human serum albumin.

5. A medicament for treating a disease with a muscle overactivity, comprising, as an active ingredient, a highly purified botulinum toxin type A S toxin (NTX), an active center protein, that is from HA-non-producing Clostridium botulinum type A isolated as infant botulism pathogen, that is not in a complex with a non-toxic protein (NTNH), and that does not comprise HA proteins, wherein said botulinum toxin type A S toxin (i) has a molecular weight of 150 kDa and (ii) has a broader therapeutic window, a broader safety margin, and exhibits a more rapid efficacy and a less diffusive property than botulinum toxins LL, L and M.

6. The medicament of claim 5 , wherein said highly purified botulinum toxin type A is produced by any HA-negative strain of Kyoto-F, Chiba-H, Y-8036, 7I03-H, 7I05-H, or KZ1828 derived from infant botulism pathogen.

7. The medicament of claim 5 , wherein said disease with a muscle overactivity is a disease induced by local overactivity, said disease being selected from strabismus, blepharospasm, hemifacial spasm, spasmodic torticollis, post-stroke spasticity, cerebral palsy, spasmodic dysphonia, headache, chronic pain, the stiffness in the shoulders, paresis occurring at the onset of Parkinson disease or multiple sclerosis, myofascial pain syndrome, spasm of the masticatory muscles, chronic anal fissure, overactive bladder, bruxism, facial myokymia, tic, local dystonia, or wrinkle.

8. The medicament of claim 5 , which further comprises a stabilizing agent for botulinum toxin.

9. The medicament of claim 8 , wherein said stabilizing agent is a human serum albumin.

10. The medicament of claim 7 , wherein the headache is a migraine headache.

11. The medicament of claim 7 , wherein the chronic pain is lumbago.

Assignments (6)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jan 15, 2020
From: THE CHEMO-SERO-THERAPEUTIC RESEARCH INSTITUTE
To: KM BIOLOGICS CO., LTD.
Reel/Frame 051520/0971 →
CHANGE OF ADDRESS OF ASSIGNEE Recorded Apr 15, 2019
From: THE CHEMO-SERO-THERAPEUTIC RESEARCH INSTITUTE
To: THE CHEMO-SERO-THERAPEUTIC RESEARCH INSTITUTE
Reel/Frame 050169/0778 →
CHANGE OF ENGLISH NAME Recorded Jan 28, 2016
From: THE UNIVERSITY OF TOKUSHIMA
To: TOKUSHIMA UNIVERSITY
Reel/Frame 037630/0710 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Aug 1, 2014
From: THE CHEMO-SERO-THERAPEUTIC RESEARCH INSTITUTE
To: THE UNIVERSITY OF TOKUSHIMA
Reel/Frame 033445/0308 →
CHANGE OF NAME Recorded Jan 16, 2013
From: JURIDICAL FOUNDATION THE CHEMO-SERO-THERAPEUTIC RESEARCH INSTITUTE
To: THE CHEMO-SERO-THERAPEUTIC RESEARCH INSTITUTE
Reel/Frame 029636/0944 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Apr 27, 2009
From: HARAKAWA, TETSUHIRO; NAKANO, HIROTOSHI; TORII, YASUSHI; GOTO, YOSHITAKA; SHINMURA, MIHO; OKUDA, SACHIO; KAJI, RYUJI; KOSAKI, SHUNJI
To: JURIDICAL FOUNDATION THE CHEMO-SERO-THERAPEUTIC RESEARCH INSTITUTE
Reel/Frame 022604/0394 →