Ambrilia Biopharma Inc.
TSX : AMB

Ambrilia Biopharma Inc.

November 02, 2006 08:00 ET

Study Shows Ambrilia's PSP94 Immunoassay to Have Prognostic Value in Prostate Cancer Management

Virginia Urology study published in Clinical Cancer Research

MONTREAL, QUEBEC--(CCNMatthews - Nov. 2, 2006) - Ambrilia Biopharma Inc.(TSX:AMB), a biopharmaceutical company developing innovative therapeutics in the fields of oncology and infectious diseases, announced today that the findings of an extensive study conducted in collaboration with Dr. Dharam Ramnani, Laboratory Director at the Virginia Urology Pathology Laboratory, Richmond, Virginia, with its PSP94 (Prostate Secretory Protein of 94 amino acids) immunoassay for the diagnosis and prognosis of prostate cancer, were published in the October 15th issue of Clinical Cancer Research (Vol. 12, pp. 6018 - 6022).

Results of the study show that in prostate cancer patients who had undergone surgery (radical prostatectomy), pre-surgery PSP94 (bound/free ratio) as well as PSPBP (PSP binding protein) were independent predictive markers of a potential recurrence of the cancer in comparison with initial total PSA (Prostate Specific Antigen), Gleason score or surgical margin status.

In the published study serum samples were obtained from 185 patients with localized prostate cancer prior to undergoing radical prostatectomy. Patients were followed for biochemical relapse as indicated by increasing total PSA levels for a median of 4 years. Pre-treatment Total PSP94, Free PSP94 and PSP94 binding protein levels were correlated with clinical variables including total PSA, Gleason score, surgical margin status and clinical stage. Biochemical relapse was observed in 31 patients and the recurrence risk significantly predicted by the clinical variables (all p less than 0.001). In addition, it was found that PSPBP was inversely associated (lower levels equals higher risk of relapse) with recurrence risk (p equals 0.008) while the ratio of bound/free PSP94 was directly associated (higher ratio equals higher risk of relapse) with recurrence risk (p equals 0.005) suggesting these to be novel and independent prognostic markers for relapse following radical prostatectomy for prostate cancer.

Prostate cancer is one of the most common cancers worldwide and the leading cancer in men in North America and Europe. According to the American Cancer Society, it is estimated that 234,460 new cases will occur in the United States during 2006 and more than 27,350 men will die from prostate cancer. Although early detection via a Digital Rectal Exam (DRE) and PSA is useful for managing prostate cancer, it is important for the patient and physician to know how aggressive the cancer is, especially in situations where both DRE and PSA are inconclusive. In patients suspected to have cancer, confirmation is achieved through analysis of biopsy samples, a procedure which is repeated if results are inconclusive. An earlier study reported by Ambrilia on December 2, 2005, showed that serum PSP94 was a very useful marker for predicting the aggressivity of the cancer as well as potentially avoiding the need for a second biopsy and associated risks of infection and other complications. The ability to distinguish aggressive cancer from slow growing or indolent cancer is crucial as the more lethal aggressive type can be effectively treated. This is also crucial for determining the recurrence of prostate cancer following surgery or other treatment regimens, again to manage the disease condition. Currently available diagnostic tests do not provide this information reliably. "The need continues for reliable markers to complement PSA testing and allow for better prostate cancer management. We believe the PSP94 based assays have the potential to be very advantageous and reliable tests in predicting prostate cancer recurrence in patients who have undergone radical prostatectomy," said Dr. Ramnani. "We have previously shown the diagnostic potential of our PSP94 immunoassay to reduce the number of unnecessary biopsies and are very pleased to now also demonstrate the prognostic value of PSP94 as a very versatile and excellent serological marker to be used in combination with PSA for predicting the recurrence of prostate cancer following surgery and/or other treatments," said Hans J. Mader, President and Chief Executive Officer of Ambrilia. "The publication of the results of the study, conducted in collaboration with a well renowned cancer centre, in a peer-reviewed journal validates our efforts in developing more reliable diagnostic/prognostic tests for prostate cancer," he concluded.

ABOUT PSP94

PSP94 is one of the three major proteins secreted in the seminal fluid, together with PSA and Prostatic Acid Phosphatase (PAP). Ambrilia develops proprietary PSP94-based test kits, available in a conventional immunoassay format, which measure the amount of free PSP94, bound PSP94 and PSP94 binding protein present in the blood. Those markers and their relative ratios have been shown to have utility in prostate cancer prognosis, diagnosis and monitoring. Ambrilia is in discussions with diagnostic companies for the co-development and marketing of PSP94 as a global diagnostic/prognostic marker for prostate cancer. At the same time, the Company is preparing a European submission with the aim of obtaining a CE marking for PSP94, within the next few months.

ABOUT AMBRILIA BIOPHARMA

Ambrilia Biopharma Inc.(TSX:AMB) is a biopharmaceutical company developing innovative and proprietary early- to mid-stage therapeutics in the fields of oncology and infectious diseases. Ambrilia's product portfolio includes an anti-cancer therapeutic peptide (PCK3145), a novel anti-cancer therapy (TVT-Dox), two oncology specialty generics (Octreotide, Goserelin), the first of which is late-stage and value-added, and promising anti-HIV treatments (PPL-100, Anti-HIV Peptides, Integrase Inhibitor Program). Exclusive worldwide rights to PPL-100 and its related compounds have been granted to Merck & Co., Inc. in return for milestone payments that could total up to $US 232 million. Ambrilia's head office, research and development and manufacturing facilities are located in Montreal with a regional office in France. For more information, please visit the Company's web site: www.ambrilia.com

Ambrilia's forward-looking statements

This press 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. Such statements are also based on various assumptions, including the successful and timely completion of clinical studies on Ambrilia's products demonstrating efficacy and safety for human use, their successful commercialization within the forecasted timelines and the attainment of the forecasted milestone payments and other revenues. While Ambrilia anticipates that subsequent events and developments may cause Ambrilia's views to change, Ambrilia specifically disclaims any obligation to update these forward-looking statements.

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