Protox files IND with U.S. FDA for prostate cancer
December 14, 2005
Vancouver, British Columbia - Protox Therapeutics Inc. announced today that it has submitted an investigational new drug (IND) application to the U.S. Food and Drug Administration (FDA) for the Company’s lead product, PRX302. Protox plans to initiate Phase 1 clinical trials of PRX302, for the treatment of recurrent localized prostate cancer, early next year, upon approval of the IND by the FDA.
“Filing our first IND with the FDA is the most important milestone for 2005 and brings us closer to fulfilling the unmet needs resulting from a cancer that afflicts more then 230,000 North American men every year,” stated Dr. Fahar Merchant, President and CEO of Protox. “This accomplishment reflects our Company’s capability and commitment to advance PRX302 for not only prostate cancer but also BPH (benign prostatic hyperplasia) and ultimately to commercialize the PORxinTM platform for these and other cancers.”
“At present there are no licensed drugs available for salvage therapy of purely local recurrence of prostate cancer,” continued Dr. Merchant. “PRX302 is a novel, first-in-class pore-forming prodrug that is activated by prostate specific antigen (PSA), an enzyme that is produced and found to be active only in the prostate. We believe that the combined use of image-guided local delivery and a pro-toxin targeted for PSA-producing cells may allow us to effectively treat localized prostate cancer without the side effects usually associated with current treatments.”
The Phase I trial will be an open-label, dose-escalation clinical trial of PRX302 in patients with locally recurrent prostate cancer and enrollment of patients is planned to begin immediately after IND activation by the FDA. Phase I trials will be conducted at Scott & White Memorial Hospital in Temple, Texas and at least one additional site in the United States. The trial is expected to enroll 18-24 patients and has been designed to determine safety, tolerability and therapeutic activity of PRX302. The company plans to file an IND for PRX302B for the treatment of BPH in 2006.
About Prostate Cancer
Prostate cancer is one of the most common malignancies in American men. It is estimated that nearly 232,090 men in the United States will be diagnosed with prostate cancer in 2005. In most men with prostate cancer, the disease grows very slowly and is initially found to be localized and confined to the gland. Nearly 30,250 men will die of prostate cancer in 2005. PRX302 is being developed for the treatment of localized recurrent prostate cancer in men with locally progressing disease without evidence of metastases. The intended route of administration for PRX302 in humans is by intra-prostatic injection.
Current treatment options for localized prostate cancer include surgery (radical prostatectomy), brachytherapy (implantation of radioactive seeds), and external beam irradiation. Unfortunately each of these therapies can result in erectile dysfunction, incontinence, urinary toxicity and rectal toxicity. To improve the outcomes for patients with localized prostate cancer adjuvant hormonal therapy or chemotherapy may also be used.
About Protox Therapeutics
Protox Therapeutics Inc. is developing novel targeted cancer therapeutics based on engineered protein toxins. Its lead programme (PORxinTM) is based on pore forming protoxins such as modified proaerolysin. PORxinsTM are inactive pro-drugs that are preferentially activated at the tumour site into potent toxins by cancer specific proteases, thereby causing cancer cell death. The Company works in partnership with research groups at the University of Victoria, Johns Hopkins University, Scott & White Hospital and other research institutions.
For more information contact:
Terry Vanderkruyk
Director, Investor Relations
Protox Therapeutics Inc.
604-688-4376 tel
604-789-0844 cell
604-688-0173 fax
Email tvanderkruyk@protoxtherapeutics.com
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