Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Nitrogen containing other than solely as a nitrogen in an...
Reexamination Certificate
2001-04-16
2004-04-27
Reamer, James H. (Department: 1614)
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
Nitrogen containing other than solely as a nitrogen in an...
C424S423000
Reexamination Certificate
active
06727287
ABSTRACT:
CROSS-REFERENCE TO RELATED APPLICATIONS
Not applicable.
STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT
Not applicable.
REFERENCE TO A MICROFICHE APPENDIX
Not applicable.
BACKGROUND OF THE INVENTION
Toluene sulfonamide is known to be a highly effective anti-fungal agent, and is useful for treating plant and animal (e.g., human) tissues infected with a fungus. For instance, U.S. Pat. No. 3,340,148 to Pugh discloses that para-toluene sulfonamide is highly effective as a topical agent for treatment of fungal skin diseases.
U.S. Pat. No. 5,981,454 to Wu discloses a toluene sulfonamide-containing composition that exhibits anti-cancer and tumor necrotizing activity. That patent discloses that the minimum effective concentration of toluene sulfonamide in such a composition is 10% by weight. The present invention relates to efficacious anti-cancer compositions that were not previously described by others.
BRIEF SUMMARY OF THE INVENTION
The invention relates to a pharmaceutical composition that exhibits anti-tumor activity. The composition comprises less than 10%, by weight, (or less than 9%, 7%, 3%, or 1%) of a toluene sulfonamide and a pharmaceutically acceptable carrier. The carrier can, for example, be an injectable carrier or an orally-administrable carrier. The precise identity of the toluene sulfonamide is not critical. The sulfonamide moiety can be in the meta-, ortho-, or para- position, and the nitrogen atom can be substituted with two hydride radicals. One or both of the hydride radicals can be replaced by a C
1
to C
6
straight, branched, or cyclic organic radical. Examples of suitable toluene sulfonamides include para-toluene sulfonamide, ortho-toluene sulfonamide, meta-toluene sulfonamide, N-ethyl ortho-toluene sulfonamide, N-ethyl para-toluene sulfonamide, and N-cyclohexyl para-toluene sulfonamide. The composition can comprise two or more toluene sulfonamides.
The pharmaceutically acceptable carrier comprises one or more additional ingredients. Suitable ingredients include 0-90% (w/w) polyethylene glycol, 0-90% (w/w) 2-ethyl-1,3-hexanediol, 0-90% (w/w) propanediol, 0-50% (w/w) decanedioic acid, 0-25% (w/w) dimethyl sulfoxide, 0-50% (w/w) ethanol, honey, a surfactant, and an emulsifier.
The invention also includes a method of making the pharmaceutical composition exhibiting anti-tumor activity. The method comprises combining a toluene sulfonamide and a pharmaceutically acceptable carrier to form the composition.
In another aspect, the invention relates to a method of inhibiting growth of a tumor in a human patient. This method comprises administering to the patient the pharmaceutical composition described herein, i.e., one comprising less than 10%, by weight, of a toluene sulfonamide. Administration of the composition to the patient inhibits growth of the tumor. The composition can be orally administered to the patient, infused into a blood vessel of the patient, injected at a tumor site in the patient, or topically applied at a tumor site.
The pharmaceutical composition described herein can also be used to shrink a tumor in a human patient who has a tumor, or to prevent tumorigenesis in a human patient who does not have, or is not recognized as having, a tumor.
REFERENCES:
patent: 3340148 (1967-09-01), Pugh
patent: 4160452 (1979-07-01), Theeuwes
patent: 4256108 (1981-03-01), Theeuwes
patent: 4265874 (1981-05-01), Bonsen et al.
patent: 4663308 (1987-05-01), Saffran et al.
patent: 4777049 (1988-10-01), Magruder et al.
patent: 4885174 (1989-12-01), Bodor et al.
patent: 4983396 (1991-01-01), Bodor et al.
patent: 5891454 (1999-04-01), Wu
patent: 1204511 (1999-01-01), None
patent: 11269 (1989-08-01), None
Shih Rocky C. S.
Wu John Y. J.
Wu Lester J.
Akin Gump Strauss Hauer & Feld & LLP
PTS International, Inc.
Reamer James H.
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