MONTREAL, Dec. 2 /PRNewswire-FirstCall/ - Procyon Biopharma Inc. , a biotechnology company developing innovative therapeutics in the fields of cancer and HIV/AIDS, announced today that the findings of an extensive study, conducted by Dr. Robert K. Nam, MD, FRCSC, Assistant Professor of Surgery, Division of Urology at the Sunnybrook and Women's College Health Sciences Centre, University of Toronto, with its Prostate Secretory Protein of 94 amino acids (PSP94) immunoassays for the diagnosis and prognosis of prostate cancer, will be published in the Journal of Urology. The study conducted with 1212 patients who underwent biopsy confirmation of prostate cancer due to either an abnormal digital rectal examination (DRE) or high Prostate Specific Antigen (PSA) showed that PSP94 serum levels were a better predictor of the aggressivity of the cancer than PSA or FTPSA (Free to Total PSA ratio).
Prostate cancer is one of the most common cancer worldwide and the leading cancer in men in Europe and North America. 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. While about 30% of males over the age of 50 are believed to have prostate cancer as determined by pathology staining of prostate biopsy samples, the overall mortality from the cancer is low due to the fact that most of the time prostate cancer is slow growing. However it is critical to detect those cases where the cancer is aggressive and could be fatal. "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", said Dr. Nam.
In the study, of the 1212 patients who underwent the diagnosis, 596 were found to have cancer. Among a subgroup of 649 men where PSA had a low predictive value and DRE was normal, 260 were found to have cancer. In this subgroup, PSP94 levels were able to discriminate between patients with high grade disease (Gleason score greater than 8), from moderate grade and low grade disease, statistically, while PSA and FTPSA could not. Patients with low serum PSP94 levels had a high probability for having prostate cancer detected at biopsy.
"We are very pleased with the findings of this extensive study which shows that our diagnostic test for serum PSP94 would be an excellent serological marker to be used in combination with PSA for seeking out patients with aggressive prostate cancer which can be fatal," said Hans J. Mader, president and chief executive officer of Procyon Biopharma. "The publication of the results in a peer-reviewed journal complements the marketing efforts of our partner, Medicorp, who is currently marketing for research purposes the three PSP94 assays developed by Procyon," he concluded.
PSP94 is one of the three major proteins secreted in the seminal fluid, together with PSA and Prostatic Acid Phosphatase (PAP). 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. These test kits differentiate between patients with prostate cancer and patients with benign conditions among patients who underwent a biopsy for prostate cancer. The PSP94-based test kits have the potential to significantly reduce the number of first and repeat prostate biopsies thus reducing the associated cost, morbidity and infection risk. Recent studies also indicate that the PSP94-based test kits were able to predict patients suffering from a more aggressive disease. PSP94 was found to be a strong predictor of relapse post- radiotherapy as well as following radical prostatectomy.
ABOUT MEDICORP INC.
Medicorp is Canada's largest privately-held independent ISO 9001- certified manufacturer and distributor of immunodiagnostic and research products. Included are enzyme immunoassay (ELISA), immunoradiometric (IRMA), and radioimmunoassay (RIA) kits for hormone and tumor marker determinations. For both academic and research laboratories, Medicorp distributes worldwide an expanding line of products in immunology, endocrinology, cell biology and molecular biology. Medicorp also offers GMP custom immunoassay development, manufacturing and packaging and GLP clinical testing services.
ABOUT PROCYON BIOPHARMA INC.
Procyon Biopharma Inc. is a biotechnology company actively engaged in the discovery and development of innovative therapeutics in the fields of cancer and HIV/AIDS. The Company leverages its strengths in research and clinical development, bringing products through late-stage clinical trials and then evaluating the best options for further development, such as co-development and licensing. Procyon's pipeline includes: PCK3145, a non-toxic peptide soon to enter a Phase II North American trial for the treatment of advanced metastatic prostate cancer; TVT-Dox, a tumor vasculature targeting technology for the treatment of solid tumors for which an IND filing is expected within 12 months; and, PPL-100, a protease inhibitor for the treatment of drug- resistant HIV/AIDS soon to enter the clinic. Procyon has won the 2005 Frost & Sullivan Award for Excellence in Technology for its overall scientific and technological contributions towards the advancement of cancer therapy. Headquartered in Montreal, Procyon shares are listed on the Toronto Stock Exchange (TSX) under the ticker symbol PBP. For more information, visit www.procyonbiopharma.com .
This release contains forward-looking statements that reflect the company's current expectation regarding future events. The forward-looking statements involve risks and uncertainties. Actual events could differ materially from those projected herein and depend on a number of factors including, but not limited to, changing market conditions, successful and timely completion of clinical studies, uncertainties related to the regulatory approval process, establishment of corporate alliances and other risks detailed from time to time in the company's filings.
PROCYON BIOPHARMA INC.