Ambrilia Biopharma Inc.

Ambrilia Biopharma Inc.

May 30, 2006 08:00 ET

Ambrilia Reports Issuance of U.S. Patent on PCK3145, its Lead Drug Candidate for Advanced Metastatic Prostate Cancer

MONTREAL, QUEBEC--(CCNMatthews - May 30, 2006) -

U.S. Patent No. 7053058 covers the Signal Transduction Inhibitor PCK3145 and related sequences

Ambrilia Biopharma Inc. (TSX:AMB), a biopharmaceutical company developing innovative therapeutics in the fields of cancer and infectious diseases, announced today that it has been notified by the U.S. Patent Office of the issuance of U.S. Patent No. 7053058 covering the sequence of PCK3145, its lead therapeutic peptide for the treatment of advanced metastatic prostate cancer, as well as 63 other related sequences. In addition the Company also received a Patent Term Adjustment of 566 days extending patent expiry to May 2023.

Research conducted by Ambrilia's collaborators and scientists has revealed that PCK3145, an anti-cancer synthetic peptide developed by the Company, binds to the cell surface laminin receptor and triggers a signaling cascade of events resulting in down-regulation of MMP-9 (matrix metalloproteinase-9) expression, a gelatinase enzyme involved in breakdown of extracellular matrix which allows tumor spread. Phase I/II clinical studies conducted in the U.K. and at the Memorial Sloan Kettering Cancer Centre in New York have shown the peptide to be non-toxic, well tolerated and to normalize MMP-9 levels in patients with high levels at the beginning of the study. When treatment was stopped the MMP-9 levels were seen to rise and once again drop with continued PCK3145 treatment. Prostate Specific Antigen (PSA) levels and some disease stabilization were observed. The studies have also confirmed that a once-a-week dosing is sufficient to normalize the MMP-9 levels in the patients.

"We are very pleased with the issuance of this key patent which represents an important milestone in the development of PCK3145," said Hans J. Mader, President and Chief Executive Officer of Ambrilia Biopharma Inc. "This enhancement of the proprietary position that we have on PCK3145 will greatly facilitate ongoing discussions we currently have with potential co-development partners to move this promising drug further along the clinical path to regulatory approval for advanced prostate cancer and possibly other metastatic cancers. In addition, we are very excited by the observations of disease stabilization seen in some patients who have received the drug over a period of 4 to 6 months and shown no adverse reactions", he added.

"Furthermore, I wish to take this opportunity to restate that Ambrilia's development programs are on track and as announced on May 10th, we expect to deliver important milestones before the end of 2006: the announcement of two partnerships for the commercialization in the U.S. and Europe of our specialty late-stage generic Octreotide and the Phase I results for our promising HIV protease inhibitor PPL-100," he concluded.


PCK3145 is a synthetic 15-mer peptide that is derived from the natural sequence of amino acids of the Prostate Secretory Protein of 94 amino acids (PSP94). PSP94 is one of three predominant proteins found in human seminal fluid along with PSA and Prostatic Acid Phosphatase (PAP).

The research team led by Professor Richard Beliveau, a world-renowned authority in oncology research, and Dr. Borhane Annabi from the Universite du Quebec a Montreal, showed that PCK3145 inhibits the binding of laminin to its receptor and leads to the down-regulation of MMP-9 levels. Laminins are a family of extracellular matrix proteins that promote the invasive characteristic of tumors, mainly through induction of proteolytic activities such as that of MMP-9. Laminin receptor mediated signaling also influences ERK (Extracellular signal-Regulated Kinase) phosphorylation. Earlier the Company reported that PCK3145 specifically antagonized in a dose-dependent manner the VEGF (Vascular Endothelial Growth Factor) -induced ERK phosphorylation as well as phosphorylation of the VEGF receptor-2 in Human Umbilical Vein Endothelial Cells (HUVECs). These latter observations established the role of PCK3145 as an anti-angiogenic agent. These observations demonstrate PCK3145's signal transduction inhibition effect and further corroborate its "hit-and-run" mode-of-action thus supporting a once-weekly administration in the upcoming Phase IIb clinical trial.

PCK3145 is currently undergoing clinical evaluation at the Memorial Sloan Kettering Institute in New York. The initial pilot study was completed and preliminary results were presented at the 2006 American Society of Clinical Oncology (ASCO) Prostate Cancer Symposium held in San Francisco in February. They confirmed the effectiveness of a once-a-week dosing at 15 mg/m2 in reducing plasma MMP-9 to normal levels, as compared to a twice-a-week dose of 7.5 mg/m2. Since the peptide has been found to be safe and non-toxic at all levels studied to date, and upon the recommendations of the members of the Prostate Cancer Clinical Trials Consortium who have expressed an interest in conducting further clinical trials with PCK3145, a further amendment to the pilot study protocol is being prepared to investigate a higher dose in this study prior to initiating the Phase IIb clinical trial. It is anticipated that a higher dose may potentially give added clinical benefit to such patients with late stage disease as well as show a potential early indication of efficacy.


Ambrilia Biopharma Inc. (TSX:AMB) is a biopharmaceutical company developing innovative therapeutics in the fields of oncology and infectious diseases. Ambrilia's product portfolio includes proprietary mid to early-stage products; an anti-cancer therapeutic peptide (PCK3145), promising anti-HIV treatments (PPL-100, SPC3), a novel anti-cancer therapy (TVT-Dox) and two specialty generics (Octreotide, Goserelin), the first of which is late-stage and value-added. Ambrilia's product candidates address unmet medical needs in oncology and infectious diseases where safe and effective therapies are needed, and which represent large market opportunities. 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:

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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