AEterna Zentaris (AEZS) reported Phase 3 results for its North American efficacy trial Z-033 and the safety trial Z-041 in benign prostatic hyperplasia (BPH), with its lead endocrinology compound for urology, cetrorelix pamoate.
The first multi-center efficacy trial Z-033 was conducted in 53 sites in the United States and Canada, with 8 additional sites in Europe. The study involved 667 patients under the supervision of lead investigator, Herbert Lepor, M.D., Professor and Chairman, Department of Urology, at NYU School of Medicine, New York. Patients entered a 1- to 4-week screening period to confirm severity and stability of voiding symptoms based on the International Prostate Symptom Score (IPSS).
The study Z-033 demonstrated no clear differences in overall efficacy with all 3 groups showing an improvement in IPSS of approximately 4 points that was maintained throughout the 52 weeks. There was a slight advantage in favor of the main active treatment arm (Arm A) up to Week 46 of the follow-up, which was no longer demonstrated at Week 52. These differences did not achieve statistical significance. Furthermore, a favorable trend on the IPSS, as compared to placebo, was seen in a sub-group of patients with large prostate glands (greater than 50 cm3) on entry to the study.
The market reacted to the lack of encouraging results by dropping shares to $.95 down from a 52-week high of $3.25.
AEZS announced earnings last week. Consolidated revenues were $8.4 million for the three-month period ended June 30, 2009, compared to $10.5 million for the same period in 2008. Consolidated net loss for the three-month period ended June 30, 2009 was $13.1 million, or $0.24 per basic and diluted share, compared to $20.6 million, or $0.39 per basic and diluted share, for the same period in 2008.
The firm has a cash balance of $57 million. Its market cap is about the same, giving the company itself a value of zero in the eyes of its investors.
Douglas A. McIntyre
