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Protox Therapeutics Inc. today announced that the Company has received Institutional Review Board approvals to proceed with its Phase 2a clinical trial evaluating PRX302 for the treatment of localized recurrent prostate cancer
VANCOUVER, Canada | January 15, 2008 | Protox Therapeutics Inc. (TSX-V:PRX), a leader in the development of targeted therapeutic proteins, today announced that the Company has received Institutional Review Board (IRB) approvals to proceed with its Phase 2a clinical trial evaluating PRX302 for the treatment of localized recurrent prostate cancer. Activities associated with patient screening have commenced and the Company expects to enroll the first patient in the first quarter of 2008.
“This is the first of three Phase 2 trials planned to commence this year,” said Dr. Fahar Merchant, President and CEO of Protox. “The Phase 2a study will enable us to build upon the favourable results from our recently completed Phase 1 studies and allow us to develop the most effective development strategy to support commercialization of PRX302.”
PRX302, a targeted PSA activated pore-forming pro-toxin, has shown promising signs of clinical and biologic activity in two Phase 1 trials. The goal of this Phase 2a study will be to optimize dosing in order to fully exploit the therapeutic potential of PRX302, while maintaining its excellent safety profile.
“The impressive results reported earlier on the Phase 1 studies provides us with the confidence that PRX302 represents a significant opportunity for the treatment of not only prostate cancer, but also BPH,” commented Dr. Samuel Denmeade, Chief Scientific Officer of Protox and co-inventor of PRX302.
About the Phase 2a Study
A total of up to 30 patients with recurrent localized prostate cancer following primary radiation therapy will be enrolled in this Phase 2a, single-arm, open-label, multi-centre study. The trial is designed to determine the optimal injection regimen that provides the maximal therapeutic benefit, while maintaining safety and tolerability of a single intra-prostatic treatment of PRX302. By increasing the volume and/or number of deposits, it is anticipated that the treatment effects of PRX302 may extend to larger volumes of the prostate and, consequently, enhance its therapeutic activity. Measure of therapeutic activity will be based on changes in PSA levels, PSA doubling time and tumour burden.
About PRX302
PRX302 is the lead drug candidate in the company’s PORxinTM technology platform. PORxin drugs are pro-drugs that are activated by specific proteases produced at elevated levels on the surface of target cells. PRX302 has been generated by engineering the naturally occurring toxin proaerolysin to create a potent agent with a distinct mode of action. The drug has been engineered so that it is activated by prostate-specific antigen (PSA), an enzyme that is overproduced in patients suffering from prostate cancer and BPH (benign prostatic hyperplasia or enlarged prostate). Once activated, the drug punches holes in the target cells causing the contents to leak out and ultimately cell death.
About Prostate Cancer
Prostate cancer is a leading cause of cancer death in North American men. One in every six men is diagnosed with prostate cancer during their lifetime. The American Cancer Society estimates that during 2007 approximately 219,000 new cases of prostate cancer will be diagnosed and over 27,000 men will die from the disease in the U.S. Current treatment options for localized prostate cancer include surgery and radiation therapy. Serious side effects are associated with these therapies including erectile dysfunction, incontinence, urinary dysfunction and bowel problems.
About Protox
Protox Therapeutics is a leader in advancing novel, targeted protein toxin therapeutics for the treatment of cancer and other proliferative diseases. Two novel drug candidates derived from the company’s INxin™ and PORxin™ platforms are being developed in three clinical programs. 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. Phase 1 clinical trials evaluating PRX302 (PORxin) have been completed for the treatment of localized prostate cancer and benign prostatic hyperplasia (enlarged prostate).
NO REGULATORY AUTHORITY HAS APPROVED OR DISAPPROVED THE CONTENT OF THIS RELEASE. THE TSX VENTURE EXCHANGE DOES NOT ACCEPT RESPONSIBILITY FOR THE ADEQUACY OR ACCURACY OF THIS RELEASE.
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.
SOURCE: PROTOX |
