Drug – bio-affecting and body treating compositions – Antigen – epitope – or other immunospecific immunoeffector – Conjugate or complex
Reexamination Certificate
1998-07-07
2001-04-03
Wortman, Donna C. (Department: 1643)
Drug, bio-affecting and body treating compositions
Antigen, epitope, or other immunospecific immunoeffector
Conjugate or complex
C424S196110, C424S197110
Reexamination Certificate
active
06210677
ABSTRACT:
FIELD OF THE INVENTION
This invention relates to a method for reducing the physiologic effects of drugs on mammals in vivo. Specifically, the method of this invention consists of inducing specific anti-drug antibodies in mammals with immunogens consisting of a drug conjugated to a carrier molecule. More particularly, the method of this invention consists of generating antibodies towards addictive substances—particularly cocaine and nicotine—such that the physiologic effects of such addictive substances are reduced. As a result, toxicity to such addictive substances is dramatically lowered in those mammals which have been treated with the immunogens prior to introduction of the addictive substance. In addition, mammals can be afforded prophylactic protection from such addictive substances by the administration of the drug-conjugated immunogen prior to introduction of the addictive substance.
BACKGROUND OF THE INVENTION
The National Institute of Drug Abuse National Household Survey on drug abuse estimated that in 1991 there were approximately 12 million persons in the United States that abused drugs. This included approximately 4.5 million occasional abusers of cocaine and greater than 800,000 habitual users of cocaine. The United States government is projected to spend an estimated $12 billion in 1993 on federal drug control programs with an estimated $2.7 billion allocated to help defray the cost of drug treatment programs. Typical methods of drug treatment therapy include psychological counseling. Heroin addiction is sometimes treated with methadone therapy to permit gradual withdrawal, however, the replacement drug methadone is itself addictive.
It would be highly desirable to develop a method to neutralize or minimize the effects of controlled substances or addictive drugs thereby rendering continued abuse of addictive substances unproductive due to the reduced physiologic effect of the drug on the user. Additionally, a physiologic reduction of the action of the drug, or reduction of the rate in which the drug effects the mammalian subject, would help contribute to reduce the toxicity of the drug. Such a method would be highly desirable in the treatment of habitual substance abusers, in the prophylactic prevention of abuse, to reduce toxicity of drugs, and may provide an additional method to slowly release toxic anti-neoplastic drugs.
SUMMARY OF THE INVENTION
The present invention consists of the administration of an immunogen consisting of a drug conjugated to a carrier molecule. The immunogen induces in the recipient the production of antibodies to the drug, as well as to the carrier molecule in most cases. Such antibodies, in turn, sequester a subsequently administered drug thereby reducing the drug's physiologic effects in the recipient. To demonstrate the method of this invention, an anti-cocaine immunogen was synthesized that markedly demonstrated a reduction in the physiologic effects and toxicity of cocaine in laboratory animals. A “reduction in the physiologic effect of a drug” is defined herein as that which can be readily observed and measured, such as heart rate, breathing rate, auditory stimulus, eye dilation, irritability, agitation, and pain reflex, in the case of cocaine.
The present invention describes a method for preventing or treating drug abuse by administering drug-conjugated immunogen that induces in the recipient antibodies, which specifically recognize and neutralize a targeted controlled substance. Such antibodies are then available in the treated recipient to reduce or eliminate the effect of a subsequent intake of the drug including reduction of the physiologic effects of subsequent drug use and reduction of the toxicity of the drug. The invention therefore is of great assistance in drug treatment programs.
The method of this invention may also be employed to reduce anti-neoplastic drug toxicity and to provide for a method of slow in vivo release of drugs.
REFERENCES:
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patent: 5773003 (1998-06-01), Swain et al.
patent: WO 92/03163 (1992-03-01), None
Bagasra, et al., Immunopharmacology, 23:173-179, Jun. 1992.*
Carrera et al., Nature, 378:727-730, Dec. 1995.*
Gallacher, G., Immunopharmacology, 27:79-81, Feb. 1994.*
Okawa, et al., Journal of Immunological Methods, 149:127-131, 1992.
Brumback Brenda G.
Townsend and Townsend / and Crew LLP
Wortman Donna C.
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