Protox advances Phase I prostate cancer study and planned BPH clinical trial
August 10, 2006
VANCOUVER, Aug. 10 - Protox(TM) Therapeutics Inc. (TSX-V:PRX)announced today that the first two cohorts of patients in its Phase I clinicaltrial for prostate cancer using PRX302 have been treated safely and that doseescalation to the third cohort will commence this month.
The Company also reported that the University of Vermont will participatein the clinical trial, joining Scott & White Memorial Hospital, the leadcenter in the trial, which began treating patients in May 2006.
"The participation of the University of Vermont and Dr. Mark Plante, thePrincipal Investigator, will ensure completion of patient recruitment for thistrial by the end of the year," said Dr. Fahar Merchant, President and ChiefExecutive Officer of Protox Therapeutics. "We look forward to reportinginterim results based on a larger number of patients in the fourth quarter."
The Phase I trial is intended to examine the safety, tolerability andtherapeutic activity of PRX302 in patients with localized recurrent prostatecancer. PRX302 is injected into the prostate under sonographic guidance. Eachnew cohort receives a higher dose of PRX302 once safety of the drug isestablished in the previous cohort. Changes in PSA levels are measured andprostate biopsies are performed after 30 days to monitor therapeutic activity.The Company today also announced the completion of a Pre-Clinical TrialApplication (CTA) meeting with Health Canada regarding a planned Phase Iclinical trial using PRX302 for the treatment of benign prostatic hyperplasia(BPH) or enlarged prostate. Based on feedback from Health Canada, Protoxintends to submit a CTA in the third quarter of 2006.
Pre-clinical studies have shown that PRX302 can destroy prostate tissuein the presence of prostate specific antigen (PSA), an enzyme that is found atelevated levels in both BPH and prostate cancer. The purpose of thedestruction is to reduce the size of the prostate and relieve the pressureexerted by the enlarged prostate on the urethra which causes a number ofpainful and bothersome urinary symptoms associated with the disease.
About Prostate Cancer
Prostate cancer is one of the most common malignancies in North Americanmen. One in every six men is diagnosed with prostate cancer during theirlifetime. It is estimated that during 2006 approximately 250,000 new cases ofprostate cancer will be diagnosed and some 30,000 men will die from thedisease throughout North America. Current treatment options for localizedprostate cancer include surgery (radical prostatectomy), brachytherapy(implantation of radioactive seeds), and external beam irradiation. Seriousside effects are associated with all these therapies including erectiledysfunction, incontinence and bowel problems.
About BPH
BPH is a common urological condition characterized by painful andbothersome symptoms that include difficulty in initiating a urine stream, asense of urgency, leaking, dribbling and presence of blood in the urine. Thecondition affects nearly 50 million men throughout North America, Europe andJapan. More than half of all men will have symptoms of BPH by age 60 and asmany as 90% may suffer from BPH after the age of 70. Current treatmentincludes watchful waiting, drug therapy, and surgery ranging from minimallyinvasive therapies to radical surgery. The most common surgical procedureperformed for BPH is transurethral resection of the prostate (TURP), howeverall currently available therapies only treat symptoms of the condition and arenot curative.
About Protox
Protox Therapeutics is a product-focused development-stage company and aleader in advancing novel, targeted protein toxin therapeutics for treatmentof cancer and other proliferative diseases. The Company currently has threeclinical programs in various stages of development for the treatment ofprimary brain cancers, localized prostate cancer and cancers that over-expressIL-4 receptors. The Company also has a pre-clinical program for benignprostatic hyperplasia (BPH) that is expected to enter clinical trials. Throughthe Company's INxin(TM) and PORxin(TM) technology platforms, therapeuticcandidates are generated by engineering the naturally occurring toxins,Pseudomonas exotoxin and proaerolysin. These drugs are potent anti-canceragents with distinct modes of action. INxin drugs target cancer cells thatproduce specific tumor associated receptors on their cell surface. Once boundto the cancer cells, INxin drugs enter the cell and inhibit protein synthesiswhich ultimately leads to cell death. PORxin drugs are pro-drugs that areactivated by specific proteases produced at elevated levels by target cells.Once activated, the drug punches holes in the cells causing the contents toleak out and ultimately cell death.
Certain statements included in this press release may be consideredforward-looking. Such statements involve known and unknown risks,uncertainties and other factors that may cause actual results, performance orachievements to be materially different from those implied by such statements,and therefore these statements should not be read as guarantees of futureperformance or results. All forward-looking statements are based on Protox'current beliefs as well as assumptions made by and information currentlyavailable to Protox and relate to, among other things, anticipated financialperformance, business prospects, strategies, regulatory developments, marketacceptance and future commitments. Readers are cautioned not to place unduereliance on these forward-looking statements, which speak only as of the dateof this press release. Due to risks and uncertainties, including the risks anduncertainties identified by Protox in its public securities filings; actualevents may differ materially from current expectations. Protox disclaims anyintention or obligation to update or revise any forward-looking statements,whether as a result of new information, future events or otherwise.
For further information: visit our website at www.protoxtherapeutics.com , or contact:
Anthony Boone, Director, Investor Relations and Corporate Communications, Protox Therapeutics, (604) 688-0199, aboone@protoxtherapeutics.com;
Michael Moore, Investor Relations, The Equicom Group, (416) 815-0700 x 241, mmoore@equicomgroup.com
