THE WOODLANDS, Texas (
) -- This morning's
conference call was boring. There was no discussion of
. The closest we got to fun was Repros CEO Joe Podolski explaining men who took the experimental testosterone-raising drug Androxal were reporting "lower rates of abstinence" and therefore had low sperm counts. (Lots of ejaculations, understand?)
Repros reported results from a second pivotal study of Androxal on Tuesday which read very much like what the company said
: Androxal, a pill, normalized testosterone levels in men with lower-than-normal testosterone and did not cause a statistically lower sperm count than placebo.
A lot of Androxal data wasn't reported Tuesday, just like it was omitted last March. Instead, Repros' Podolksi offered assurances about Androxal's efficacy and safety, even while remaining non-committal about presenting complete results from the two clinical trials at a medical meeting.
The company intends to file Androxal for approval with the FDA in the middle of next year.
Repros shares rose 21% to 25.62 Tuesday, so like last March, investors are brushing off the real risk FDA rejects Androxal.
Androxal is a variant of the female reproductive hormone Clomid which Repros is developing as a treatment for men with low testosterone. Right now, men with "low T" are prescribed various testosterone-laden gels and creams --
Axiron. The worldwide testosterone market is $2 billion annually and growing but these rub-on treatments are messy, carry the risk of transference and cause sperm counts to fall. (A big negative for men who still want to father kids.) As a pill, Androxal is designed to be much more convenient, can't be transferred to kids or women, and most importantly, doesn't lower sperm count.
In the second phase III study disclosed Tuesday, Repros said 81% of Androxal-treated men reached normal testosterone range, which exceeded the 75% threshold requirement under the Special Protocol Agreement reached with the FDA.
Seventy-nine percent of men on Androxal reported normal testosterone in the first phase III study.
What was the rate of testosterone normalization for men treated with placebo in the phase III study? Repros did not disclose.
What were the baseline and end-of-treatment levels of testosterone for patients in both arms of the study? Repros did not disclose.
Was the testosterone normalization endpoint reached with statistical significance? Repros did not disclose.
The terms "statistical significance" or "statistically signifcant" do not appear in today's press release.
The study's sperm count endpoint is similarly messy.
Twenty of 134 men on Androxal reported sperm counts that fell 50% below their baseline levels compared to 2 of 47 men on placebo. While numerically worse, Repros said the Androxal was statistically non inferior to placebo but only just barely. To meet the study's sperm-count endpoint, Androxal could be no more than 20% worse than placebo. The reported statistical difference was 18.3%.
Last March, Repros admitted that one of the clinical trials sites fabricated baseline sperm counts for patients. As a result, the company analyzed the study omitting patients from that troubled site. Here, the statistical worsening in sperm count reduction was 19.6%, meaning the study came within a whisper of failing on this endpoint.
Repros also slipped in a change to the reporting from the first phase III study. Tuesday, the company said 16 of 113 Androxal-treated men reported sperm counts lower than 50% from baseline. Last March, it was 15 of 113 patients.
Under the SPA agreement, Androxal must meet both primary endpoints in both phase III clinical trials in order for the study to be considered successful.
On Tuesday, Repros said it "believes" the sperm-count endpoint was met. Why not just make a definitive statement? Repros CEO Podolski blamed his lawyers for wanting to be conservative.
Repros must complete an Androxal safety study plus finish some preclinical work before submitting for FDA approval in the middle of next year. The company is also still working through a
by a New York urologist who claims
-- Reported by Adam Feuerstein in Boston.
Adam Feuerstein writes regularly for TheStreet. In keeping with company editorial policy, he doesn't own or short individual stocks, although he owns stock in TheStreet. He also doesn't invest in hedge funds or other private investment partnerships. Feuerstein appreciates your feedback;
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