|
|
|
January 8, 2007
QuatRx Pharmaceuticals Reports Positive Results from Phase II Trial of Fispemifene
QuatRx was founded by a team led by Bob Zerbe, a highly experienced drug development executive from Warner-Lambert. Bob led the team that had developed Lipitor, the world's best selling drug with $12 billion in sales in 2005, and started QuatRx to in-license and develop drugs to treat metabolic and cardiovascular disease. Below, the company reports positive results from a Phase II trial of fispemifene, a novel orally available medicine for testosterone deficiency.
--------------------------------
QuatRx Pharmaceuticals today announced positive results
from its Phase II clinical study of fispemifene in men
with low testosterone levels. Fispemifene is a new, selective
estrogen receptor antagonist that is being developed as
an oral treatment for testosterone deficiency and associated
disorders in men. Symptoms of low testosterone include
sexual dysfunction, muscle wasting, reduced bone density,
lowered energy levels and glucose intolerance. Unlike
current exogenous testosterone treatments, fispemifene
is administered orally once daily and is designed to use
the body's natural mechanism to increase and maintain
testosterone levels within the body's normal physiologic
range.
In the randomized, double-blind, placebo-controlled study
conducted at 23 sites in the United States, 77 men with
secondary hypogonadism were evaluated after four weeks
of treatment. Patient groups treated with 100, 200 and
300 mg doses of fispemifene showed a 60%, 60% and 78%
increase in testosterone levels, respectively, compared
to baseline, while patients treated with placebo showed
a 14% increase in testosterone levels (p<0.05, p<0.01,
p<0.001 (fispemifene vs. placebo), respectively). Actual
increases in total testosterone ranged from 28.3 ng/dL
for placebo to 196.5 ng/dL for 300 mg fispemifene. In
all dose-groups the mean testosterone level increased
into the normal range of 300 ng/dl to 900 ng/dl. All primary
endpoints defined by the study protocol were met and no
safety issues were observed.
Back to News
|
|
| |
