"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
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
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
For the three months ended
Research and development ("R&D") costs for Q3, 2009 were
Direct costs incurred in Q3, 2009 for the PRX302 clinical programs for the treatment of BPH and prostate cancer as well as activities associated with maintaining the PRX321 program totaled
General and administrative ("G&A") costs for Q3, 2009 were
At
As at
For complete financial results, please see the Company's filings at www.sedar.com.
About Protox
Protox Therapeutics is a leader in advancing novel, receptor targeted fusion proteins. Two novel drug candidates derived from the company's INxin(TM) and PORxin(TM) platforms are being developed in three clinical programs. Protox's lead program, PRX302 (PORxin), is currently being studied in a Phase 2b placebo controlled trial called TRIUMPH, to treat benign prostatic hyperplasia (BPH or enlarged prostate). Positive Phase 2a results at three months treating BPH patients were released at the end of 2008 and extended data demonstrated durability and efficacy at 12 months. PRX302 is also being evaluated for the treatment of localized prostate cancer. A Phase 2a clinical trial evaluating PRX321 (INxin) for the treatment of primary brain cancer has been completed and the drug has received Fast Track Designation and Orphan Drug Status from the US FDA and EMEA. Protox is also collaborating with the U.S. National Institutes of Health (NIH) on a research program focused on the discovery of next generation fully human targeted therapeutics.
Certain statements included in this press release may be considered forward-looking. Such statements involve known and unknown risks, uncertainties and other factors that may cause actual results, performance or achievements to be materially different from those implied by such statements, and therefore these statements should not be read as guarantees of future performance or results. All forward-looking statements are based on Protox' current beliefs as well as assumptions made by and information currently available to Protox and relate to, among other things, anticipated financial performance, business prospects, strategies, regulatory developments, market acceptance and future commitments. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. Due to risks and uncertainties, including the risks and uncertainties identified by Protox in its public securities filings; actual events may differ materially from current expectations. Protox disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
For further information: James Beesley, Senior Director, Investor Relations, Protox Therapeutics, (604) 484-0975, [email protected]; Michael Moore, Vice President, Investor Relations, Equicom Group, (416) 815-0700 x 241, [email protected]
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