Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Having -c- – wherein x is chalcogen – bonded directly to...
Reexamination Certificate
2000-03-14
2001-05-01
Jones, Dwayne C. (Department: 1614)
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
Having -c-, wherein x is chalcogen, bonded directly to...
C514S063000, C514S185000, C514S410000
Reexamination Certificate
active
06225333
ABSTRACT:
TECHNICAL FIELD
The present invention is in the field of photodynamic therapy such as may be applied in treating cancers.
BACKGROUND
Photodynamic therapy (PDT) is a treatment that is based upon the differential uptake by cancerous cells of photosensitizing agents, followed by irradiation of the cells to cause a photochemical reaction that is believed to generate chemically disruptive species, such as singlet oxygen. These disruptive species in turn injure the cells through reaction with cell parts, such as cellular and nuclear membranes. Photodynamic therapy has been used successfully for treating several types of cancer cells.
However, certain types of cancers, such as the very virulent pigmented melanoma, are known to be poorly responsive to photodynamic therapy (PDT) with FDA-approved photosensitizing agents such as Photofrin, a haematoporphyrin derivative (1), as well as with several second generation phototherapeutic agents (2) whose lowest energy absorption band lies in the 600-700 nm spectral range. This lack of response is generally ascribed to optical filtering of the incident light by the melanin granules, which are expressed with a particularly high frequency in this tumor type.
One avenue taken used to address this problem has been to attempt to develop and use new photosensitizing agents that have energy absorption bands deeper in the infrared region than those mentioned above. One of the difficulties in this approach has been that such new photosensitizing agents are not as effective in their generation of disruptive species once irradiated, and they require further FDA approval.
Accordingly, it is an object of the present invention to develop effective techniques whereby pigmented cancer cells may be treated by PDT, including through techniques that apply efficient and approved photosensitizing agents.
In view of the present disclosure and the practice of the present invention, other advantages of the present invention may become apparent.
SUMMARY OF THE INVENTION
The present invention in general terms includes a method of treating cancerous tissues characterized by high concentrations of pigmented compounds, the method including irradiation of the neoplastic tissue with light of comprising the steps: (1) subjecting the cancer tissue to relatively high power light which is absorbed by the pigment so as to substantially reduce its amount in the pigmented cancerous cells; (2) treating the tumour with one or more photosensitizing agents; followed by (3) subjecting the tumour tissue to relatively low power light absorbed by the photosensitizer so that the photosensitizer is promoted to a more reactive state and induces a series of chemical and biological events causing the disruption of the integrity of the tumour cells or their ability to maintain metabolism or reproduce.
As used herein, reference to substantial reduction of the amount of the pigment in the cells shall be understood as meaning reducing the amount of pigment in the cell so as to render it sufficiently translucent to the relatively low power light used to activate the photosensitizing agent(s).
The method of the present invention may be applied to any pigmented cancer cells, such as melanoma cells pigmented with melanin.
The relatively high power light may be provided by any appropriate light source such as by a laser adapted to provide high peak power laser irradiation. Typically, such high peak power laser irradiation preferably will provide submicrosecond pulsed power output of at least about 10
2
mJ pulsed over 10 nanoseconds.
The one or more photosensitizing agent may be any photosensitizing agent, including those selected from the group consisting of tetrapyrrol-based photosensitizers, such as porphyrins (e.g., haematoporphyrin), chlorins, phthalocyanines and naphthalocyanines (e.g., such as Si(IV)-naphthalocyanine). Such photosensitizing agents may also include those selected from the group consisting of coumarins and psoralens.
REFERENCES:
Sarna et al., “Photosensitization of Melanins: A comparitive Study”, Photochemistry and Ohotobiology vol. 42, No. 5, pp. 529-532, 1985.*
Dougherty, T.J. (1987) Photosensitizers: therapy and detection of malignant tumours. Photochem. Photobiol., 45, 879-889.
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Marcus S. (1996) Clinical photodynamic therapy: the continuing evolution. In Photodynamic therapy: basic principles and clinical applicatio. Marcel Dekker New York (Edited by Henderson B. W. and Dougherty T. J.) pp. 219-268.
Biolo. R., G. Jori, M. Soncin, R. Pratesi, U. Vanni, B. Rihter, M.E. Kenney and M. A. J. Rodgers (1994) Photodynamic therapy of B16 pigmented melanoma with liposeme-delivered Si(IV)—naphathalocyanine. Photochem. Photobiol.59, 362-365.
Biolo. R., Jori, M. Soncin, B. Rihter, M.E. Kenney and M. A. J. Rodgers (1996) Effect of photosensitizer delivery system and irradiation parameters on the efficieny of photodynamic therapy of B16 pigmented melanoma in mice. Photochem. Photobiol. 63, 224-228.
Sounik J. R., L. A. Schechtman, B. D. Rihther, W. E. Ford, M. A.J. Rodgers and M. E. Kenney (1990) Synthesis and characterization of naphthalocyanines and phthalocyanines of use in sensitizer studies. In Photodynamic Therapy: Mechanisms II. SPIE vol. 1203 (Edited by T. J. Dougherty and A.Katzir), pp. 224-232.
Anderson R. R. amd J.A. Parrish (1982) Optical properties of human skin. In The science of photomedicine. Plenum Press, New York (Edited by Regan, J. D. and J.A. Parrish), pp. 174-194.
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Cuomo V., G. Jori, B. Rihter, M.E. Kenney and M. A. J. Rodgers (1990) Liposomes—delivered Si(IV)—naphthalocyanine as a photodynamic for experimental tumors: pharmacoikinetic and phtottherapeutic studies. Br. J. Cancer 62, 966-970.
Fitzpatrick T. B., G Szabo (1959) The melonocyte : cytology and cytochemistry. J Invest Dermatol 32, 197-209.
Schuitmaker J. J., J. A van Best, J. L. van Delft, J. E. Jannink, J, A. Oosterhuis, G. F. J. M. Vrensen, D. de Wolff-Rouendaal, T. M. A. R. Dubbelman (1995) Photodynamic therapy of Hamster green melanoma in vitro and in vivo usin bacteriochlorin a as photosensitizer. In Photochemoterapy: Photodynamic Therapy and other modalities. SPIE vol 2625 (Edited by Ehrenberg B., Jori G., Moan J.) pp. 251-260.
Moan J., Q. Peng, V. Iani, L. Ma, R W. Horobin, K. Berg, M. Kongshang and J. M.Nesland (1995) Biodistribution, pharamacokinetic and in vivo fluorescence spectroscopic studies of photosensitizer. In Photodynamic Therapy and other modalities. SPIE vol 2625 (Edited by Ehrenberg B., Jori G., Moan J.) pp. 234-250.
Schoenfeld N., R. Mamet, Y. Nordenberg, M. Shafran, T. babushkin and Z. Malik. (1994). Photoporphyrin biosynthesis in melanoma B16 cells stimulated by 5—aminolevulinic acid and chemical inducers: characterization of photodynamic inactivation. Inc. J. Cancer, 56 106-116.
Sarna T., I. A. Menon and R. C. Sealy (1985) Photosensitization of melanins: a comparative study Photochem. Photobiol. 42 529-532.
Maon J., Peng Q., Iani V., Ma L., Horobin R., Berg K. and Kongshaug M. (1996) Bidistribution, pharmocokinetic and in vivo Fluorescence spectroscopic studies of photosensitizers. SPIE 2625 234-250.
Database CAPLUS on STN, No. 1996:168613, Young et al., “Photodynamic therapy of pigmented choroidal melanomas using a liposomal preparation of benzoporphyrin derivative.” Arch. Opthalmol. (Chicago). Abstract, 1996 114(2), pp. 186-192.
Database BIOSOS on STN, No. 1995:255603, Gonzales et al., “Photodynamic Therapy of Pigmented Choroidal Melanomas” Investigtive Opthalmology & Visual Science. Abstract, 1995, 36(5), pp. 871-878.
Jori Giulio
Kenney Malcolm E.
Rodgers Michael A. J.
Bowling Green State University
Jones Dwayne C.
Standley & Gilcrest LLP
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