March 27 Repros Therapeutics Inc said
its experimental drug to treat low levels of testosterone met
the main goals of a key study, succeeding in bringing patients'
testosterone levels to a normal range.
The results come after a delay announced in January when
Repros said it identified certain discrepancies in the study
population and sought FDA guidance on data analysis. The
company's stock has halved since then.
Repros said the late-stage study of 113 patients, in which
its drug Androxal was compared to a placebo, had required that
75 percent of subjects given the drug show a 24-hour average
total testorone in a normal range at the end of the 12 weeks.
Results showed 79 percent of the intent-to-treat patients
were within the normal range and that no single subject
exhibited any testosterone assessment at any time that was above
the normal range -- a finding important for the FDA's safety
A separate analysis showed 83 percent of men that completed
the study were within the normal range, the company said.
The study also met goals related to sperm count.
Chief executive Joseph Podolski said Repros expects to
complete enrolling patients in a second late-stage study on
Androxal by the end of May.
The drug is being studied as a treatment for secondary
hypogonadism, a condition where parts of the brain responsible
for stimulating the testes to produce testosterone do not
The drug is expected to compete with AbbVie Inc's
Androgel, Auxilium Pharmaceuticals Inc's Testim and Eli
Lilly and Co's Axiron, all of which are already on the
Androxal is one of Repros's two products in development. The
other, Proellex, is being tested to treat uterine fibroids -
noncancerous tumors that develop in the womb.
Repros shares closed at $9.13 on Wednesday on the Nasdaq,
down about 42 percent since the beginning of this year.