Ambrilia Biopharma Inc.

Ambrilia Biopharma Inc.

August 28, 2007 08:01 ET

Ambrilia Completes Patient Recruitment for the Phase 3 Pivotal Clinical Trial of its Prolonged Release Formulation of Octreotide

MONTREAL, QUEBEC--(Marketwire - Aug. 28, 2007) - Ambrilia Biopharma Inc. (TSX:AMB) announced today that it has completed patient recruitment into the pivotal phase 3 clinical trial of its proprietary prolonged release formulation of Octreotide ("C2L").

"Completion of patient recruitment in the pivotal phase 3 trial is an important achievement in C2L's clinical development plan", said Dr. Bonabes de Rouge, Senior Executive Vice-President and Chief Scientific Officer, Ambrilia. "We are therefore on track to meet our objective of completing the efficacy study by the end of 2007", he added.

The open-label, randomized, parallel group, two-arm, multi-center, phase 3 study compares the efficacy of C2L 30mg and Sandostatin®LAR 30mg, based on changes in the mean Insulin-like Growth Factor 1 ("IGF-1") and Growth Hormone ("GH") plasma levels in acromegalic patients. In this efficacy study, C2L is administered every 42 days for 84 days and Sandostatin®LAR is administered every 28 days for 84 days (2 injections of C2L versus 3 injections of Sandostatin®LAR in a 3-month period). Comparison of safety profiles, drug plasma concentrations and other clinical efficacy measures will also be assessed.

Additional 3 to 9-month open-label safety studies will follow the completion of the efficacy study. Regulatory filings by Ambrilia's licensing partners are then expected to start mid 2008, first in Europe followed by North America.


Ambrilia's product is a proprietary prolonged release formulation of Octreotide. The original product is commercialized as Sandostatin®LAR (octreotide acetate for injectable suspension, a registered trademark of Novartis Pharmaceuticals Corporation). Octreotide is used for the treatment of a rare disease called acromegaly caused by a tumor of the pituitary gland, and for certain rare digestive tumors.

Acromegaly is a serious chronic condition related to a permanent hypersecretion of growth hormone (GH) by the pituitary gland, generally of tumoral origin. This causes an excessive production of Insulin-like Growth Factor 1 (IGF-1), a hormone secreted from the liver and other tissues. Excessive production of IGF-1 and GH results in uncontrolled growth of various organs, and debilitating symptoms. Control of the GH and IGF-1 levels by Octreotide normalizes such excessive growth and symptoms. Appropriate treatment has been shown to improve quality of life, and more importantly to increase life expectancy, in patients with acromegaly. It is a life long treatment, with few, mild side effects.

Ambrilia's forward-looking statements

This press release contains forward-looking statements that reflect the Company's current expectation regarding future events. These 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. We refer you to the Risk Factors section of the Company's Management's Discussion & Analysis of Financial Condition and Results of Operations which contain a more exhaustive analysis of the risks and uncertainties that are generally connected to the business of the Company. 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, unless obligated to do so by applicable securities laws.


Ambrilia Biopharma Inc. (TSX:AMB) is a biopharmaceutical company developing novel small molecules and peptides to treat infectious diseases and cancer. Ambrilia's product portfolio includes promising anti-HIV treatments (PPL-100 and an HIV Integrase Inhibitor Program), two new formulations of existing drugs developed with a patented technology (Octreotide and Goserelin), an anti-cancer therapeutic peptide (PCK3145), a tumor and tumor-vasculature targeting (TVT) technology platform, as well as other anti-virals and immunomodulators. Exclusive worldwide rights to PPL-100 and its related compounds have been granted to Merck & Co., Inc. in return for milestone payments and royalties. 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:

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