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Extensive in vivo and in vitro experimental trials have been carried out on Soyselect® to provide a complete pharmacological profile.
In vivo
estrogenic activity in animal models of menopause (1-4):
Soyselect® in the immature rat uterotrophic assay has shown no effect, leaving unchanged uterine weight when compared to controls.
Soyselect® in the ovariectomized rat (OVX) model of menopause produced a bone-sparing effect associated with a slowing down in the increased bone turnover observed after ovariectomy (as indicated in table 1 by measurements of serum osteocalcin levels and urinary excretion ratio of deoxypyridinoline, DPD). Organ weight data and histopathological analysis did not show any stimulatory activity of Soyselect® on the uterus, thus suggesting a tissue specific response.
Table 1: bone-related parameters in rats after treatment
with
SOYSELECT® or 17-ß estradiol
anticancer activity (5-7):
the chemopreventive effect of Soyselect® has been evaluated on 7,12-dimethylbenz[a]anthracene (DMBA) induced mammary tumors in rats. Only tumors classified
as adenocarcinomas were considered for data evaluation. In treated animals, mammary tumors took a longer period of time to develop, with a dose-dependent percentage reduction of poorly differentiated tumors.
antiangiogenic activity (8):
Soyselect® has been proven effective in inducing a significant inhibition of angiogenesis caused by means of basic Fibroblast Growth Factor (bFGF) in athymic nude mice.
In vitro
antioxidant activity (9-11):
Soyselect® and its isoflavone fraction has been evaluated
by means of different experimental models (cells free,
membrane and cell systems).
cardiovascular protective activity (12-13):
Soyselect® isoflavone fraction has been evaluated for
the inhibiotn of polymorphonuclear leukocytes (PMN) adhesion to activated platelets or endothelial cell lining on
the injured vascular wall. This mechanism is involved in the
inflammatory process and tissue damage characteristic
of some pathological situation such as reperfusion injury,
atherosclerosis and thrombosis.
(1) Report Pharm/04/03 - Indena S.p.A., Internal File.
(2) Report Pharm/05/03 - Indena S.p.A., Internal File.
(3) Gallo D., Zannoni G.F., Apollonio P., Martinelli E., Ferlini C., Passetti G., Riva A., Morazzoni P., Bombardelli E., Scambia G., Menopause 12, 589 (2005).
(4) Report Pharm/08/03 - Indena S.p.A., Internal File.
(5) Report Pharm/03/98 - Indena S.p.A., Internal File.
(6) Gallo D., Giacomelli S., Cantelmo F., Zannoni G.F., Ferrandina G., Fruscella E., Riva A., Morazzoni P., Bom-bardelli E., Mancuso S., Scambia G., Breast Cancer Res. Treat. 69, 153 (2001).
(7) Gallo D., Ferrandina G., Giacomelli S., Fruscella E., Zannoni G.F, Morazzoni P., Riva A., Bombardelli E., Mancuso S., Scambia G., Cancer Lett.186, 43 (2002).
(8) Report Pharm/20/02 - Indena S.p.A., Internal File.
(9) Report Istituto Chimico e Tossicologico dell’ Università degli Studi di Milano, 24 September 1999 - Indena S.p.A., Internal File.
(10) Report Istituto Chimico e Tossicologico dell’Università di Milano, 7 December 2000 - Indena S.p.A., Internal File.
(11) Maffei Facino R., Carini M., Aldini G., Piccone M., Morazzoni P., Bombardelli E., Joint Meeting of the ASP, AFERP, GA and PSE 1999, 2000 Years of Nat. Prod. Res. “Past, Present and Future”, July 26-30, Amsterdam, 1999.
(12) Report Consorzio Mario Negri Sud, 22 June 2001 - Indena S.p.A., Internal File.
(13) Rotondo S., Totani L., Manarini R., Piccoli A., Martelli N., Pecce R., Riva A., Morazzoni P., Evangelista V., Food & Nutrition for Better Health, 13-15 June 2001, Santa Maria Imbaro - Lanciano, Italy.
