Drug – bio-affecting and body treating compositions – Plant material or plant extract of undetermined constitution... – Containing or obtained from a root – bulb – tuber – corm – or...
Reexamination Certificate
1998-08-14
2001-07-31
Witz, Jean C. (Department: 1651)
Drug, bio-affecting and body treating compositions
Plant material or plant extract of undetermined constitution...
Containing or obtained from a root, bulb, tuber, corm, or...
Reexamination Certificate
active
06267994
ABSTRACT:
BACKGROUND OF THE INVENTION
The invention relates to the use of an extract of
Cimicifuga racemosa
for treating estrogen-dependent tumors.
Extracts of the rhizome of the black cohosh (
Cimicifugae racemosae rhizoma
) exhibit estrogen-like effects. Components which bind specifically to estrogen receptors and are able to lower gonadotropin levels in ovariectomized rats have been found in the extracts. It has therefore proved to be of value to administer these extracts for the purpose of treating climacteric complaints and dysmenorrhea.
The use of estrogen-containing pharmaceuticals for regulating climacteric complaints is out of the question in the case of patients who are at risk of mammary carcinoma since the growth of estrogen-dependent tumors is naturally augmented by administering estrogen. Since the mechanism by which estrogen-analogous substances act is still unclear, a risk of estrogen-dependent tumors has, as a precaution, been regarded as a contraindication in regard to administering these substances.
It has been reported (Nesselhut et al. in TW Gynäkologie (1993) pages 249 to 250) that relatively low concentrations of the plant drugs rhaponticin and Cimicifuga extract augment the proliferation of carcinoma cells in vitro.
It is also known to treat estrogen-dependent tumors with an antiestrogenic active compound. The currently most popular active compound of this type is tamoxifen (Z)-2-[4-(1,2-diphenyl-1-butenyl)phenoxy]-N,N-dimethyl-ethylamine.
For the above mentioned reasons, it was not possible to consider using estrogens or estrogen-analogous substances to regulate the climacteric complaints of the patients who were being treated with an antiestrogen of this nature.
Whether or not the proliferation of mammary tumor cells is inhibited depends on the concentration of the tamoxifen. However, it is not possible to increase the concentration to a range at which proliferation of the tumor cells is reliably prevented, since tamoxifen becomes toxic at these concentrations.
The present invention therefore takes, as its starting point, the problem of achieving tumor therapy even when using relatively low concentrations of anti-estrogen.
SUMMARY OF THE INVENTION
It is therefore an object of the invention to provide compositions which are useful in antitumor therapy, but avoid the toxicity of high doses of known antiestrogenic compounds. According to this object, compounds are provided which comprise an extract of a medicinal plant of the genus Cimicifuga and, preferably, an antiestrogenic compound. In one embodiment, the antiestrogenic compound is tamoxifen. In yet another embodiment, the antiestrogenic compound is genistein.
It is another object of the invention to provide pharmaceutical compositions suitable for use in antitumor therapy that provide a greater degree of tumor inhibition than known antiestrogenic compounds. According to this object, the inventive compositions are admixed with a pharmaceutically acceptable excipient. In a preferred embodiment, the pharmaceutical compositions are provided in a unit dose form, which contains the extract from about 5 mg to about 500 mg of Cimicifuga plant material.
It is yet another object of the invention to provide methods of treating tumors. According to this object, methods are provided that are especially suited for the treatment of estrogen-dependent tumors. Methods are described, comprising administering compositions which comprise Cimicifuga extracts, either alone or in combination with at least one antiestrogenic compound. The combination methods provide greater effectiveness at lower doses of known antiestrogenic compound. In one embodiment, a composition comprising an extract of a medicinal plant of the genus Cimicifuga is administered to a patient in need of treatment in a therapeutically effective amount. In a preferred embodiment, the composition administered further comprises at least one antiestrogenic compound. In another embodiment, the antiestrogenic compound is tamoxifen. In yet another embodiment, the antiestrogenic compound is genistein. In a preferred embodiment, a therapeutically effective amount of the extract includes from about 5 mg to about 500 mg of Cimicifuga plant material daily.
REFERENCES:
patent: 5569459 (1996-10-01), Shylankevichg
Patent abstract of Japan, vol. 15, No. 1 (C-0793), Jan. 7, 1991 & JP 02 255622 A (Tsumura & Co). Oct. 16, 1990.
T. Nesselhut et al., “Untersuchungen Zur Proliferativen Potenz Von Phytopharmaka Mit Ostrogenvahnlicher Wirkung Bei Mammakarzinomzellen,”, Archives of Gynecology and Obstetrics, vol. 254, Nos. 1-4, 1993, pp. 817-818, XP002060552.
G. Rauthe; “Wechseljahresbeschwerden bei Mammakarzinompatientinnen,” Fortschr. Med. 114, 1996, pp. 26/46 -30/48.
Bodinet Cornelia
Freudenstein Johannes
Nesselhut Thomas
Schneider Peter
Foley & Lardner
Meller Mike
Schaper & Bruemmer GmbH & Co. KG
Witz Jean C.
LandOfFree
Use of extract of cimicifuga racemosa does not yet have a rating. At this time, there are no reviews or comments for this patent.
If you have personal experience with Use of extract of cimicifuga racemosa, we encourage you to share that experience with our LandOfFree.com community. Your opinion is very important and Use of extract of cimicifuga racemosa will most certainly appreciate the feedback.
Profile ID: LFUS-PAI-O-2436209