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Drug developed at UC Davis may prevent breast cancer, treat post-menopausal vaginal atrophy
Drug developed at UC Davis may prevent breast cancer, treat
post-menopausal vaginal atrophy
November 03, 2005
20-year collaboration between UC Davis and Finnish researchers
led to new drug
(SACRAMENTO, Calif.
) - A tamoxifen-like drug developed by UC
Davis and Finnish researchers, now in clinical testing as a
treatment for vaginal atrophy, may also help to prevent breast
cancer, two preliminary studies suggest.
The studies, based on research in a mouse model of human breast
cancer, will be published in the November issue of the Journal of
Steroid Biochemistry and Molecular Biology and the December issue
of Breast Cancer Research.
"These reports indicate that prevention of breast cancer may be
another benefit of the use of ospemifine," said Michael W.
DeGregorio, a professor of medicine at UC Davis.
"The findings are
very encouraging."
DeGregorio is senior author of the November article and a
contributing author of the December paper. He has spent the last 20
years developing ospemifene in collaboration with Risto
Lammintausta, managing director of Hormos Medical Corp. in Turku,
Finland.
Ospemifene is now being developed by QuatRx Pharmaceuticals, an
Ann Arbor, Mich.-based biopharmaceutical company that recently
merged with Hormos Medical Corp. The drug is expected to enter
Phase 3 clinical testing in the United States early next year for
the treatment of vaginal atrophy, a common condition among
postmenopausal women.
Ospemifene is one of a class of drugs called selective estrogen
receptor modulators.
The well-known agent tamoxifen, used to
prevent breast cancer in women at high risk for the disease, and
raloxifen, currently used to prevent bone fractures in women with
osteoporosis, belong to the same class.
In the Journal of Steroid Biochemistry and Molecular Biology,
DeGregorio and his colleagues at UC Davis compared the ability of
ospemifene, tamoxifen and raloxifen to inhibit breast cancer in
mice exposed to a carcinogen. Ospemifene and tamoxifen both
inhibited breast cancer development: Mice in the ospemifene group
were 95 percent less likely than mice in the control group to
develop breast cancer. Raloxifen had no such effect.
The study is
available online in advance of its publication in print at
www.sciencedirect.com.
The second study, led by Jeffrey P.
Gregg, an associate
professor of pathology and laboratory medicine at UC Davis, reports
that in a mouse model, both tamoxifen and ospemifene inhibited the
growth and progression of pre-malignant breast lesions that closely
resemble human ductal carcinomas in situ. Both these agents
decreased the growth of the lesions by reducing the proliferation
rate of the precancerous cells.
The article is available online in advance of its print
publication date at www.breast-cancer-research.
com.
While similar, tamoxifen, raloxifen and ospemifine have
variations in chemical structure that give them unique therapeutic
profiles. For example, raloxifen can prevent bone fractures, but it
can also cause hot flashes, insomnia and blood clots. Tamoxifen can
decrease a high-risk woman's odds of developing breast cancer by
half, but the drug also increases the risk of endometrial cancer
and can cause the same side effects as raloxifen.
In clinical tests so far, ospemifene appears to have a unique
estrogen-like effect on the vagina, yet a neutral effect on the
endometrium, or lining of the uterus, and no aggravation or
initiation of hot flashes. Results of the Phase 1 and Phase 2
tests, conducted in postmenopausal women in Finland, appear in the
journal Menopause in September 2003 and March 2005.
"Dr. Lammintausta and I worked for many years to find a drug
that would have beneficial effects in healthy, postmenopausal women
but be absolutely safe," said DeGregorio.
"We're gratified that
this seems to be the case."
Decreased estrogen levels can lead to a thinner, less elastic
and more fragile vaginal lining. Known as vaginal atrophy, the
problem affects 10 to 40 percent of post-menopausal women. Symptoms
may include dryness, itching, burning, irritation, a
feeling of pressure, and pain or
light bleeding with sex.
Estrogen creams, rings, patches or oral
supplements are often prescribed
to treat vaginal atrophy.
University of California,
Davis-Health System
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