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Protox Receives IRB Approval to Conduct Clinical Testing of PRX302
at a Leading U.S. Hospitals
Thursday, October 20, 2005 - Vancouver, British Columbia - Protox Therapeutics
Inc. announced today that it has received approval from the Institutional Review
Board (IRB) at the Scott and White Memorial Hospital and Clinic in Temple,
Texas (Scott and White) to conduct a Phase 1 clinical study of PRX302 for the
treatment of localized, recurrent prostate cancer. The clinical study may begin
once Protox has submitted an Investigational New Drug Application (IND) to the
United States Food and Drug Administration (US FDA) and is informed by the US
FDA that Protox may proceed with the Phase 1 study.
"Obtaining IRB approval at a leading hospital such as Scott and White provides
considerable credibility to our lead candidate PRX302 and our planned clinical
program", said Dr. Fahar Merchant, President and CEO of Protox. He added,
"we are pleased that, once we secure US FDA approval of our IND, we shall be
able to initiate the Company's first human clinical trial at Scott and White."
The Company intends to file its first IND this Quarter, as reported on August 26,
2005, and once approved will initiate a Phase I clinical trial at Scott and White
and at least one additional U.S. site.
The Principal Investigator for this study will be Dr. K. Scott Coffield, M.D.,
Professor of Surgery, who leads the Genitourinary Cancer Team and is Program
Director of Urology Residency as well as Urological Research coordinator at the
Texas A&M University System College of Medicine. He is board certified in
urology and specializes in urologic oncology.
Investigators Arthur Frankel, M.D., Arthur Boyer, Ph.D., Laura Culp, M.D., Robert
Hall, M.D., and Thomas Kuehl, Ph.D. will be part of the Scott and White team
working with Coffield on this Phase I study.
"The need to extend therapy options for prostate cancer which has failed primary
radiation therapy and remains confined to the prostate has generated interest in
injection of biological agents which potentially eradicate residual prostate
cancer," stated Coffield. "The novel agent of Protox Therapeutics Inc., PRX302,
may permit prostate cell specific eradication of cancer with a method which holds
promise for an even wider application in the management of this common
malignancy which impacts quality and quantity of life of over 200,000 men
diagnosed each year in this country alone."
The Phase 1 study is intended to examine the safety and tolerability of local
injections of PRX302 into the prostate. The study is designed to determine the
dose limiting toxicity (DLT) and the maximum tolerated dose (MTD) in patients
with biopsy-proven localized prostate cancer without distant metastases who
have already received primary radiotherapy and still show biochemical failure.
PRX302 is injected into the prostate under sonographic guidance using a
modification of the method developed for radon seed brachytherapy. The
Company believes that local therapy with PRX302 will result in destruction of
some or all of the remaining active tumor tissue.
About Scott and White
Scott and White is the largest multi-specialty practice in Texas with more than
500 physicians and is considered to be one of the foremost healthcare
institutions in the US. The hospital is ranked among the top 15 major teaching
hospitals in the US. Scott and White is affiliated with the Texas A&M University
College of Medicine and its physicians are involved in clinical trials that focus on
improving patient care, treatment outcomes and medical safety.
About Protox Therapeutics
Protox Therapeutics Inc. is developing novel therapeutics for the treatment of cancer and other indications by engineering the naturally occurring bacterial protein Proaerolysin, which kills cells by puncturing their cell membrane after activation by proteases at the tumour site (PORxin). The Company believes that its engineering approach will produce targeted cancer therapeutics that may have greater efficacy and fewer side effects than existing treatments.
About PRX302
PRX302 is a genetically engineered form of the bacterial protoxin, Proaerolysin
which is injected directly into the prostate where it is converted to the active toxin
Aerolysin, by the serine protease, Prostate Specific Antigen (PSA). Aerolysin
oligomerizes to form a stable heptamer, which inserts into the cell membrane of
healthy and cancerous prostate cells to produce channels in the cell membrane
leading to leakage of cellular contents and cell death. Protox plans to initiate
Phase I human clinical trials of PRX302 for the treatment of localized recurrent
prostate cancer and benign prostatic hyperplasia (BPH or enlarged prostate),
representing large unmet clinical needs with a potential combined world-wide
market in excess of $17 billion US. (Theta Reports, 2004)
About Prostate Cancer
Prostate cancer is one of the most common malignancies in North American
men. It is estimated that approximately 230,000 men in the United States will be
diagnosed with prostate cancer in 2005. In most men with prostate cancer, the
disease progresses very slowly and it is initially found to be confined to the gland.
Approximately 30,000 American men will die of prostate cancer in 2005.
For more information, contact:
Terry Vanderkruyk
Director, Investor Relations, Protox Therapeutics Inc.
Tel: 604-688-4376
Cell: 604-789-0844
Fax: 604-688-0173
tvanderkruyk@protoxtherapeutics.com
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