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news.Zonagen has received European approval to begin a phase II study comparing its lead compound Proellex to Tap Pharmaceutical's Lupron in the treatment of endometriosis.
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The European phase II study will enroll 40 women and compare three doses of double blinded Proellex against open label Lupron, the current standard of care, for up to six months of treatment. Zonagen expects to have reportable interim three-month results from the study in the fourth quarter of 2006.
Proellex is also being studied in a US phase II trial for the treatment of uterine fibroids. This study will enroll 150 patients and will compare two doses of Proellex versus placebo in a double-blind design. Data from this trial is not expected until at least late Q3, 2006.
Along with its update on Proellex, Zonagen also announced financial results for the year and fourth quarter ended December 31, 2005. The company reported that total revenues for 2005 were $634,000, as compared to $257,000 for 2004.
Net loss for the three-month period ended December 31, 2005, was $2.3 million or, as compared to a net loss of $744,000 for the same period in the prior year, and was -$7.4 million for the 12-month period ended December 31, 2005, as compared to -$3.7 million for the same period in the prior year.
The increase in loss per share for the three-month and twelve-month periods ended December 31, 2005 was primarily due to an increase in clinical research activities relating to Androxal and Proellex.