* Arzoxifene meets primary goals of second Phase III study
* Raises bone mineral density, compared with placebo
(Adds details on trial, results, share price)
By Ransdell Pierson
NEW YORK, April 8 Eli Lilly and Co (LLY.N) said
on Wednesday its experimental osteoporosis drug arzoxifene has
achieved its primary goals in a second late-stage clinical
trial among postmenopausal women.
The Indianapolis drugmaker said the latest favorable
results for the drug were seen in a Phase III study among 311
women aged 45 to 60, all of whom had normal or low bone mass.
Low bone mineral density is considered a risk for developing
the bone-thinning condition.
Subjects received either daily 20 milligram doses of
arzoxifene or a placebo. All women also received daily
500-milligram supplements of calcium.
After two years, arzoxifene increased bone mineral density
of the lumbar spine and of the total hip by 2.9 percent and 2.2
percent, respectively, compared with placebo. The results were
deemed statistically significant.
There was no significant difference among the two groups in
incidence of adverse events, except that vaginal yeast
infections were seen among 4 percent of women taking the Lilly
drug, but among none in the placebo group.
There were no significant differences among the arzoxifene
and placebos groups in incidence of cancer or endometrial
hyperplasia, a thickening in the lining of the uterus that can
be a precursor to endometrial cancer.
Data from the trial, called Foundation, were described in
the online edition of the Journal of Clinical Endocrinology &
The published results come several weeks after favorable
data from another Phase III study of arzoxifene, called Next,
among postmenopausal women with osteoporosis. In that trial,
arzoxifene proved superior to Lilly's older osteoporosis drug
Evista in increasing bone mineral density in the lumbar spine,
total hip and femoral neck regions.
Both Lilly drugs are members of the family of
osteoporosis-prevention drugs called selective estrogen
receptor modulators, or SERMs.
Lilly shares rose 1.4 percent to close at $32.34 on the New
York Stock Exchange.
(Reporting by Ransdell Pierson; Editing by Andre Grenon)