Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Web – sheet or filament bases; compositions of bandages; or...
Reexamination Certificate
2002-02-21
2004-07-13
Kishore, Gollamudi S. (Department: 1615)
Drug, bio-affecting and body treating compositions
Preparations characterized by special physical form
Web, sheet or filament bases; compositions of bandages; or...
C424S449000, C424S443000
Reexamination Certificate
active
06761900
ABSTRACT:
INTRODUCTION
Field of the Invention
The field of this invention is delayed-type hypersensitivity inducing agents.
BACKGROUND OF THE INVENTION
The number of Human Immunodeficiency Virus (HIV) patients worldwide has been increasing rapidly in recent years, and is said to be approximately 33 million (WHO; end of 1998). Against this backdrop, there is a rush to develop a vaccine for HIV. However, but because of the mutation of the configuration of the virus following infection, a feature of HIV, an accurate vaccine has not yet been found. In addition, although many therapeutic medications for HIV have been developed, none completely cure HIV. Furthermore, current AIDS drugs (protease inhibitors, non-nucleoside reverse transcriptase inhibitors, nucleoside reverse transcriptase inhibitors, etc.) employ complex techniques. Long-term administration of these agents causes patients to suffer persistent adverse events, such as anemia, peripheral neuritis, pancreatitis, nausea, and headaches. Also, the possibility of long-term administration resulting in drug resistance cannot be ruled out. Yet another disadvantage of current treatment modalities is cost, in that current therapeutic medications for HIV are extremely expensive, often ranging between $15,000 to $20,000 per person per year, which necessarily limits patient access.
One type of agent that represents an effective alternative to current HIV treatment modalities is the delayed-type hypersensitivity (DTH) inducing agent, which type of agent has been researched as an immunomodulator that elicits immunological response in HIV patients by increasing the activity of the immune system cells in the body. Delayed-type hypersensitivity inducers are substances that induce Type 4 hypersensitivity when they come into contact with human skin, and they include trinitrobenzene sulfonic acid, picryl chloride(PC), 2,4-dinitrofluorobenzene(DNFB), and 1-chloro-2,4-dinitrobenzene (DNCB). Of these, DNCB has been widely used in the treatment of HIV and in immunological research, and the present invention focuses on DNCB as a DTH inducer in many embodiments, as described in greater detail below.
DNCB was discovered in Germany before World War II. Research conducted in the 1950s in the US demonstrated that DNCB is not carcinogenic. Later, in the 1970s, safety research was conducted in various types of animals. DNCB is generally known to be a powerful, delayed allergy-inducing skin irritant in humans, and is used in, among other things, immunological tests of skin diseases.
Research on DNCB therapy in HIV patients began slowly from the middle of the 1980s, and research on DNCB therapy in HIV patients was conducted in the first half of the 1990s, from which DNCB was claimed to be effective for treating HIV. However, this claim was not proved. In the latter half of the 1990s, the development of PCR analysis technology began to confirm the efficacy of DNCB in HIV patients. In addition, DNCB was also previously investigated as a possible treatment for cancer: tests were conducted in which DNCB was applied locally to induce a delayed allergic reaction and thereby utilize its immunity inducing capabilities. However, these findings have not been put to practical use. Furthermore, DNCB has been used in, among other things, the treatment of warts.
A method for using DNCB in HIV patients that has been employed in recent years has been to dissolve the DNCB in an acetone solvent and impregnate a gauze-like cloth with the resulting product and apply this to the skin. This topical preparation is then dried, covered and left to stand for several hours (typically at least 8 hours). This long application time means that an HIV patient would be restricted for at least 8 hours, a fairly long time, which would prevent that person from leading the same lifestyle as a healthy person.
There is considerable interest, therefore, in the development of a topical DTH inducing agent composition that could efficiently deliver an effective amount of a DTH inducing agent to a host in a short period of time.
Relevant Literature
References of interest include: Stricker et al. Dendritic cells and dinitrochlorobenzene (DNCB): A new treatment approach to AIDS.
Immunol Letters
1991;29:191-196; Stricker et al. Pilot study of topical dinitrochlorobenzene (DNCB) in human immuno deficiency virus infection.
Immunol Letters
1993;36:1-6; Stricker et al. Topical dinitrochlorobenzene in HIV disease.
J Am Acad Dermatol
1993;28:796-797; Stricker et al. Clinical and immunologic evaluation of HIV-infected patients treated with dinitrochlorobenzene (DNCB).
J Am Acad Dermatol
1994;31:462-466; Stricker R B, Goldberg B, Mills L B, Epstein W L. Improved results of delayed-type hypersensitivity skin testing in HIV-infected patients treated with topical dinitrochlorobenzene(DNCB).
J Am Acad Dermatol
1995;33:608-611; Stricker & Goldberg. Safety of topical dinitrochlorobenzene.
Lancet
1995;346:1293; Stricker et al. Improved results of delayed-type hypersensitivity skin testing in HIV-infected patients treated with topical dinitrochlorobenzene.
J Am Acad Dermatol
1996;35:491-493; Stricker et al. Decrease in viral load associated with topical dinitrochlorobenzene therapy in HIV disease.
Res Virol
1997;148:343-348; Traub et al. Topical immune modulation with dinitrochlorobenzene (DNCB) in HIV disease: A controlled trial from Brazil.
Dermatology
1997;195:369-373; Stricker et al. Topical immune modulation (TIM): A novel approach to the immunotherapy of systemic disease.
Immunol Letters
1997;59:145-150; Oracion et al. DNCB treatment of HIV-infected patients leads to beneficial immunologic outcomes, reduced viral load, and improved measures of quality-of-life.
J Invest Dermatol
1998;110:476.
SUMMARY OF THE INVENTION
Topical patch preparations that contain a delayed-type hypersensitivity inducer, e.g., 1-dichloro-2,4-dinitrobenzene (DNCB), and methods for using the same are provided. The subject topical patch preparations are made up of an adhesive gel composition that is present on a support, where the adhesive gel composition includes the delayed-type hypersensitivity inducer, a water-soluble polymer gel, water and a water holding agent. In using the subject topical patch preparations, the topical patch preparations are applied to a skin surface of a subject and maintained at the site of application for a period of time sufficient for an effective amount of the delayed-type hypersensitivity inducer to be administered to the subject, where this maintenance period typically does not exceed about 60 minutes. The subject invention finds use in a variety of applications where the administration of a delayed-type hypersensitivity inducer is desired, and is particularly suited for use in the treatment of HIV associated disease conditions, e.g., AIDS.
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Stricker et al. “Decrease in viral load associated with topical dinitrochlorobenzene therapy in HIV disease”Res Virol(1997) 148:343-348.
Oracion et al. “DNCB treatment of HIV-infected patients leads to beneficial immunologic outcomes, reduced viral load, and improved measures of quality-of-life”J. Invest Deermatol.(1998) 110:476.
Stricker et al. Dendritic cells and dinitrochlorobenzene (DNCB): A new treatment approach to AIDSImmunol Letter(1991) 29:191-196.
Stricker et al. “Pilot study of topical dinitrochlorobenzene (DNCB) in human immuno deficiency virus infection”Immunol Letters, (1993) 36:1-6.
Stricker et al. “Tropical dinitrochlorobenzene in HIV disease”J. Am. Acad Dermatol(1993) 28:796-797.
Stricker et al. Clinical and immunologic evaluation of HIV-infected patients treated with dinitrochlorobenzene (DNCB).J. Am. Acad Dermatol(1994) 31:462-466.
Stricker et al. Improved results of delayed-type hypersensitivity skin testing in HIV-inf
Mori Ichiro
Shudo Jutaro
Bozicevic Field & Francis LLP
Field Bret E.
Ghali Isis
Kishore Gollamudi S.
Teikoku Pharma USA Inc.
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