Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – 9,10-seco- cyclopentanohydrophenanthrene ring system doai
Reexamination Certificate
1995-06-07
2001-09-18
Dees, Jose G. (Department: 1616)
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
9,10-seco- cyclopentanohydrophenanthrene ring system doai
C514S167000
Reexamination Certificate
active
06291443
ABSTRACT:
TECHNICAL FIELD
The present invention relates, in general, to a method of preventing or treating alopecia, and, in a specific embodiment, to a method of preventing or treating alopecia induced by chemotherapeutic agents.
BACKGROUND
Alopecia is a common and distressing side effect of many chemotherapeutic agents and for which there is currently no effective preventive measure. In a recent study, thirty-five of forty-six patients receiving chemotherapy ranked alopecia as more important than vomiting (Tierney et al, B. J.
Cancer,
62:527-528, 1990).
Recently, using the young rat model, Applicants demonstrated that ImuVert, a biologic response modifier prepared from the bacterium
Serratia marcescens,
protected the animals from alopecia induced by cytosine arabinoside or adriamycin (Hussein et al,
Science
249: 1564-1566, 1990). In subsequent studies, similar protection from ARA-C-induced alopecia was observed from recombinant interleukin-1 (IL-1) beta (Jimenez et al
FASEB J.
1991).
The present invention provides an independent method of preventing and treating chemotherapy-induced alopecia. This method involves the use of a growth factor, such as epidermal growth factor (EGF) or fibroblast growth factor (FGF). It should be noted that, as far as Applicants are aware, ImuVert has not been shown to stimulate the production of EGF or FGF, nor has it been proposed to stimulate such production.
The present invention also relates to the use of Vitamin D
3
, or a metabolite thereof, alone or in combination with EGF to prevent or treat alopecia. Vitamin D
3
is absorbed after ingestion of fish liver oils or irradiated yeast. Plants and animal sources contain only the inactive vitamin D precursors, 7-dehydrocholesterol or ergosterol. 7-Dehydrocholesterol is stored in the skin and can be converted by sunlight into vitamin D
3
. However, whether ingested or formed by ultraviolet irradiation in the skin, Vitamin D has to be transformed into active metabolites. Vitamin D
3
is converted to 25-hydroxycholecalciferol by liver enzymes. Then in the kidneys two compounds 1,25-dihydroxycholecalciferol and 24,25-dihydroxycholecalciferol are formed. The vitamin D active metabolites play an important role in the absorption of calcium from the intestinal tract, bone deposition and bone reabsorption.
1,25-Dihydroxyvitamin D
3
, an active metabolite of Vitamin D
3
, has been shown to increase EGF receptors on breast cancer cells (Falette et al, Molec. and Cell. Endocrinol., 63 (1-2):189-198, 1989) and on a cell line established from rat calvaria (Petkovich et al, J. Biol. Chem. 262 (28):13424-13428, 1987). However, as far as Applicants are aware, the effect of Vitamin D
3
or a metabolite thereof, on alopecia has not been shown or proposed.
SUMMARY OF THE INVENTION
It is a general object of the invention to provide a method of treating or preventing alopecia. It is a specific object of the invention to prevent or treat alopecia in patients undergoing treatment with chemotherapeutic agents, including cycle specific agents (such as cytosine arabinoside (ARA-C)) and non cycle specific agents (such as Cytoxan), individually or in combination.
Further objects and advantages of the invention will be clear from the description that follows.
REFERENCES:
patent: 4425916 (1984-01-01), Bowen
patent: 4566455 (1986-01-01), Kramer
patent: 5017371 (1991-05-01), Cummins
patent: 5342411 (1994-08-01), Maxted et al.
patent: 5449668 (1995-09-01), Sestelo et al.
Jimenez Joaquin J.
Yunis Adel A.
Dees Jos,e G.
Greenberg & Traurig, LLP
Pryor Alton
Rzucidlo Eugene C.
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