Procyon's PSP94 blood test detects severity of prostate cancer, study shows

By Angela McDaniels

Seattle, Dec. 2 - Procyon Biopharma Inc. said a company study found that prostate secretory protein of 94 amino acids (PSP94) levels were a better predictor of the aggressivity of prostate cancer than prostate-specific antigen levels or a patient's free-to-total prostate-specific antigen ratio.

The study was designed to evaluate the company's PSP94 immunoassays for the diagnosis and prognosis of prostate cancer.

Patients underwent biopsy confirmation of prostate cancer after an abnormal digital rectal examination or detection of high prostate-specific antigen levels. Of the 1,212 patients who underwent the diagnosis, 596 were found to have cancer.

Among a subgroup of 649 men where prostate-specific antigen levels had a low predictive value and the digital examine was normal, 260 were found to have cancer. In this subgroup, PSP94 levels were able to discriminate among patients with high-grade, moderate-grade and low-grade disease, while the other indicators could not, the company said.

Patients with low serum PSP94 levels had a high probability for having prostate cancer detected at biopsy. PSP94 was also found to be a strong predictor of relapse after radiotherapy and radical prostatectomy, the company said.

"This is the first report of a serological marker which can predict both the presence of prostate cancer and help identify patients with high-grade or stage disease at diagnosis better than PSA or FTPSA ratio in a clinical setting," lead investigator Robert K. Nam of the University of Toronto said in a company news release.

The findings will be published in the Journal of Urology, and marketing partner Mediocre Inc. has begun marketing Procyon's three PSP94 assays developed for research purposes, the company said.

PSP94 is one of the three major proteins secreted in the seminal fluid. PSP94-based test kits measure the amount of free PSP94, bound PSP94 and PSP94-binding protein present in the blood, the relative ratios of which are believed to have utility in prostate cancer prognosis, diagnosis and monitoring, the company said.

These test kits differentiate between patients with prostate cancer and patients with benign conditions and have the potential to significantly reduce the number of prostate biopsies, thus reducing the associated cost, morbidity and infection risk, the company said.

Prostate cancer is one of the most common cancers worldwide and the leading cancer in men in Europe and North America, the company said. According to the American Cancer Society, it is estimated that 232,090 new cases will occur in the United States during 2005 and more than 30,000 men will die from prostate cancer.

Procyon is a Montreal-based biotechnology company that develops therapeutics in the fields of cancer and HIV/AIDS.

Mediocre, also based in Montreal, manufactures and distributes immunodiagnostic and research products.

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