Protox Therapeutics Inc. (TSX: PRX), a leader in the development of receptor targeted fusion proteins, today announced financial results for the third quarter, ended September 30, 2009.
"During the third quarter we were very pleased to report impressive results from our open-label Phase 2 study of PRX302 for the treatment of moderate to severe benign prostatic hyperplasia, and to announce completion of enrollment in our Phase 2b TRIUMPH trial of PRX302," said Dr. Fahar Merchant, President and CEO of Protox. "In our open label study, patients who received an optimal dose of PRX302 demonstrated a twelve point improvement in the International Prostate Symptom Score (IPSS) after one year following a single treatment, almost double that seen with oral therapies and comparable to many surgical procedures. These very encouraging data have only increased our anticipation for the top-line results from our TRIUMPH study, which are expected within the next 2 months."
Third Quarter 2009 Highlights:
- Completed patient enrollment in the TRIUMPH Phase 2b study, a multi-centre, double-blinded, placebo controlled trial evaluating PRX302 in 92 males with moderate to severe benign prostatic hyperplasia (BPH). Top line results from the study are anticipated in December 2009 or early January 2010. - Announced positive 12 month data from the open-label Phase 2 study of PRX302, indicating that males with moderate to severe BPH who received an optimal dose of PRX302 continued to demonstrate significant symptomatic relief at 12 months following a single treatment. No safety issues were identified in this study and no sexual dysfunction has been reported in any of the subjects dosed to date. Detailed data from this study were presented at the 30th World Congress of the Société Internationale d'Urologie Conference on November 2nd, 2009.
FINANCIAL RESULTS
During the third quarter of 2009 and first nine months of 2009, the Company earned interest income of $3,000 and $46,000 respectively, compared to $91,000 and $229,000 for the corresponding periods in 2008. Interest income and investment returns have declined as a result of lower balances available to earn investment income, and lower returns available in the market.
Total expenses in Q3, 2009 increased over the preceding quarter due to the continuing level of activity in the Company's lead program, PRX302 for the treatment of BPH, with full enrollment of the TRIUMPH study achieved in September 2009.
For the three months ended September 30, 2009, the Company reported a net and comprehensive loss of $2.2 million or ($0.03) per share compared with $2.5 million or ($0.03) per share for the three months ended September 30, 2008. The net loss for the nine months ended September 30, 2009 totaled $6.3 million or ($0.08) per share compared with $6.4 million or ($0.09) per share for the nine months ended September 30, 2008. The modest decrease in net loss over the comparative period in 2008 was primarily driven by a decrease in research and development costs as the effect of clinical program consolidation takes effect, as well as the impact of efforts to reduce costs across all areas of the Company, including general and administration. This was offset by an increase in stock based compensation during the quarter which resulted from the issuance of 2,155,000 options within Q3, 2009 - the first issuance in 2009.
Research and development ("R&D") costs for Q3, 2009 were $1.5 million compared to $2.0 million for the Q3, 2008. R&D costs for the nine months ended September 30, 2009 were $4.4 million compared to $4.6 million for the nine months ended September 30, 2008. The decreases for the periods reflect the effect of the consolidation of the research and development programs to focus on the lead BPH program.