Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Radical -xh acid – or anhydride – acid halide or salt thereof...
Reexamination Certificate
1998-12-29
2001-06-26
Jones, Dwayne C. (Department: 1614)
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
Radical -xh acid, or anhydride, acid halide or salt thereof...
C424S045000
Reexamination Certificate
active
06251941
ABSTRACT:
BACKGROUND OF THE INVENTION
Retinoids are a class of naturally occurring and synthetic derivatives of Vitamin A which function in vivo as regulators of a number of physiological functions including cellular proliferation, cytodifferentiation and embryonal morphogenesis. This class includes a number of clinically important compounds such as those shown
FIG. 1
which have been shown or hypothesized to have utility in the therapy and prevention of various types of cancer. For example, Hong et al., N. Eng. J. Med. 323: 795-801 (1990) have shown that adjuvant treatment with 13-cis retinoic acid after definitive anti-cancer treatment in patients with carcinoma of the head and neck significantly reduces the incidence of secondary tumors of the aerodigestive tract. Head and neck cancer, like lung cancer, is significantly related to tobacco smoking, and in fact many of the tumors reduced in incidence in the Hong et al. study were lung cancers. Retinoids have also been shown to be effective in the prevention and reversal of certain types of induced hyperplasia and metaplasia in cultured rodent respiratory epithelia. Lasnitzki et al., Cancer Treatment Reports 66: 1375-1380 (1982).
Unfortunately, while retinoids have been shown to provide beneficial effects in the prevention of at least some types of cancer, the therapeutic regiment requires chronic administration. Under these circumstances, substantial systemic toxicity may result, including hyperlipidemia, hypercalcemia, and skin, liver and central nervous system toxicity. This toxicity has limited the utility of retinoids as therapeutic agents in the prevention of cancer.
SUMMARY OF THE INVENTION
We have now developed a system for administration of retinoids by inhalation to overcome the chronic toxicity problems presented by systemic administration and to make retinoid therapy available as an option for the prevention of epithelial cancers of the respiratory tract, especially those that are associated with tobacco use. Thus, in accordance with the present invention, there is provided a method for prevention of epithelial cancer of the respiratory tract in an at-risk individual, comprising administering by inhalation to the respiratory tract of the individual an air-borne composition (i.e., an aerosol or finely divided dry powder) comprising a therapeutically effective amount of at least one retinoid. The retinoid is suitably administered with a metered dose aerosol producing inhaler, in which the retinoid is dissolved in a combination of a pharmaceutically acceptable chlorofluorocarbon propellant and an amine solubilizing agent.
REFERENCES:
patent: 4529600 (1985-07-01), Dawson et al.
Hong et al., “Prevention of Secon Primary Tumors with isotretinon in squammous-cell carcinoma of the head and neck”, New Engl. J. Med. 323:795-801, (1990).*
Moren et al., Aerosols in Medicine, Principles, Diagnosis and Therapy, 1993.*
Aerosols in Medicine,F. Moren et al., eds. Elsevier, New York, New York, 1993.
Molecusol brochure (1988).
Hong et al., “Prevnetion of Second Primary Tumors with Isoretinoin in Squamous-Cell Carcinoma of the Head and neck”New Engl. J. Med.323: 795-801 (1990).
Laznitzki et al., “Prevention and Reversal by a Retinoid of 3,4-beanzpyrine—and Cigarette Smoke Condensate-induced Hyperplasia and Metaplasia of Rodent Respiratory Epithelia in Organ Culture”,Cancer Treatment Rep.66: 1375-1380 (1982).
Warrell, Jr., R.P., “Retinoids in Cancer”, inImmunoPharmaceuticals,E.S. Kimball, ed., CRC Press, New York, New York, 1993, pp. 101-128.
Osol et al.., Editor of Remington's Pharmaceutical Sciences, 15th Edition, 1975, p. 1651.*
Windholz et al., Editor of The Merk Index, 10th Edition, p. 1381, 1983.*
Stein et al., Editor of Internal Medicine, 45th Edition, Chapters 71-72, pp. 699-715, 1993, 1975.
Tong William P.
Warrell Raymond P.
Jones Dwayne C.
Oppedahl & Larson LLP
Sloan-Kettering Institute for Cancer Research
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