BioXell starts Phase IIa trial of elocalcitol in male infertility

The trial is designed to test the ability of elocalcitol to improve sperm quality in infertile male patients. Results are expected for the end of 2008.

The trial will involve a total of 234 infertile male patients with poor sperm quality and no known specific causes of infertility, and will test elocalcitol at doses of 75mcg and 150mcg versus placebo for an effect on various sperm parameters. Treatment duration is four months, preceded by three months of pre-screening/washout and one week of medication-free run-in, and with a one month follow-up after treatment.

The primary endpoint is total sperm motility (percentage), with secondary endpoints including forward motility (percentage), total and forward motility (absolute value), morphology (atypical cells), conception rate, IL-8 seminal plasma levels, leukocytes in the semen and safety and tolerability.

Enrico Colli, chief medical officer and head of R&D at BioXell, said: “Elocalcitol is emerging, through accumulated evidence from clinical and preclinical studies, as a potential treatment of choice for urological disorders with an inflammatory component. There are strong reasons to believe that male infertility, for which there is a large unmet medical need, may also be one of these indications, broadening the potential therapeutic range of our lead compound.”