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EP0488583A2 Expired / Lapsed EP ⏱️ 0.0 years remaining

Improved kit and method for administration of bacillus calmette-guerin

Assignee: Jewish Hospital of St Louis
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Filing: 1991-11-21
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Granted: —
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Expires: 2011-11-21
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Abstract

Abstract Improved treatment of superficial bladder tumors through the administration by intravesical instillation of bacillus Calmette-Guerin is realized through the use of a therapeutic composition comprising bacillus Calmette-Guerin (BCG) suspended in an 0.85 to 0.90 wt % (i.e. about 0.15 M) sodium chloride solution containing a buffer to maintain the pH of the solution in the range 6.6 to 7.4, preferably 7.0. A kit and method are provided whereby such a composition may be employed to maximize intravesical attachment of BCG for improved efficacy.

Inventors

  • 👤 Timothy L. Ratliff
  • 👤 M'liss A. Hudson
  • 👤 Julie K. Ritchey

Bibliographic Details

Application Number —
Jurisdiction EP
Data Source google_patents
Last Synchronized 2026-10-23 22:44
CPC Classifications
A; A61; A61K; A61K47/00; A61K47/06; A61K47/22; A61K35/00; A61K35/66; A61K35/74; A61K47/02; A61K47/16; A61K47/18; A61K47/183; A61K47/20; A61K9/00; A61K9/0012; A61K9/0034

Claims Analysis

Total Claims: 13
Claim 1
Independent Claim 45 words
A therapeutic composition for the treatment of superficial bladder tumors in a mammal, comprising bacillus Calmette-Guerin (BCG) suspended in an 0.85 to 0.90 wt % sodium chloride solution containing a buffer to maintain the pH of said solution in the range of 6.6 to 7.4.
Claim 2
Dependent Claim 20 words
A composition as claimed in claim 1 wherein said sodium chloride solution is maintained at a pH of approximately 7.0.
Claim 3
Dependent Claim 34 words
A composition as claimed in claim 1 or 2 wherein said buffer is selected from the group consisting of phosphate, Tris (hydroxymethyl) aminomethane, N-tris[hydroxymethyl]-methyl-2-aminoethanesulfonic acid, N,N-bis[2-hydroxyethyl]-2-aminoethanesulfonic acid, 3-(N-morpholino)propanesulfonic acid, 3-(N-morpholino)-2-hydroxy-propanesulfonic acid, and N-[2-hydroxyethyl]piperazine-N′-[2-ethanesulfonic acid].
Claim 4
Dependent Claim 37 words
A composition as claimed in any one of claims 1 to 3 formed from a kit comprising: (a) a dosage amount of BCG in lyophilized form; and (b) an 0.15 M sodium chloride solution containing said buffer.
Claim 5
Dependent Claim 41 words
A composition as claimed in any one of claims 1 to 4 formed by reconstituting 120 mg of BCG in lyophilized form in 50 mls of 0.15 M sodium chloride solution containing said buffer and suitable for administration by intravesical instillation.
Claim 6
Dependent Claim 23 words
The use of a therapeutic composition as claimed in any one of claims 1 to 5 in the treatment of superficial bladder tumors.
Claim 7
Dependent Claim 60 words
A kit for use in the in vivo treatment of superficial bladder tumors through the administration by intravesical instillation of bacillus Calmette-Guerin, comprising: (a) a dosage amount of bacillus Calmette-Guerin in lyophilized form; and (b) an 0.85 to 0.90 wt % sodium chloride solution containing a buffer to maintain the pH of said solution within the range 6.6 to 7.4.
Claim 8
Dependent Claim 20 words
A kit as claimed in claim 7 wherein said sodium chloride solution is maintained at a pH of approximately 7.0.
Claim 9
Dependent Claim 34 words
A kit as claimed in claim 7 or 8 wherein said buffer is selected from the group consisting of phosphate, Tris (hydroxymethyl) aminomethane, N-tris[hydroxymethyl]-methyl-2-aminoethanesulfonic acid, N,N-bis[2-hydroxyethyl]-2-aminoethanesulfonic acid, 3-(N-morpholino)propanesulfonic acid, 3-(N-morpholino)-2-hydroxy-propanesulfonic acid, and N-[2-hydroxyethyl]piperazine-N′-[2-ethanesulfonic acid].
Claim 10
Independent Claim 51 words
A method for the treatment of superficial bladder tumors in a mammal, which comprises administering to said mammal a therapeutic composition comprising bacillus Calmette-Guerin suspended in an 0.85 to 0.90 wt % sodium chloride solution containing a buffer to maintain the pH of said solution in the range 6.6 to 7.4.
Claim 11
Dependent Claim 20 words
A method as claimed in claim 10 wherein said sodium chloride solution is maintained at a pH of approximately 7.0.
Claim 12
Dependent Claim 33 words
A method as claimed in claim 10 or 11 wherein said buffer is selected from the group consisting of phosphate, Tris (hydroxymethyl)aminomethane, N-tris[hydroxymethyl]-methyl-2-aminoethanesulfonic acid, N,N-bis[2-hydroxyethyl]-2-aminoethanesulfonic acid, 3-(N-morpholino)propanesulfonic acid, 3-(N-morpholino)-2-hydroxy-propanesulfonic acid, and N-[2-hydroxyethyl]piperazine-N′-[2-ethanesulfonic acid].
Claim 13
Dependent Claim 19 words
A method as claimed in claim 10 wherein said treatment is continued for a period of approximately 2 hours.

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