Ambrilia Biopharma Inc.

Ambrilia Biopharma Inc.

August 29, 2007 08:00 ET

Ambrilia Reports Positive Results From Phase 2 Study of its Prolonged Release Formulation of Octreotide

MONTREAL, QUEBEC--(Marketwire - Aug. 29, 2007) - Ambrilia Biopharma Inc. (TSX:AMB) reported today positive top-line results from the first clinical study of its prolonged release formulation of Octreotide ("C2L") in acromegalic patients. Data from a single-dose administration of C2L in 8 patients indicated that C2L normalizes the major marker for acromegaly, the Insulin-like Growth Factor 1 ("IGF-1"), and suppresses high Growth Hormone ("GH") plasma levels, with no serious adverse events reported. Furthermore, efficacy and pharmacokinetic data suggested a 42-day dosing interval for C2L in comparison to a 28-day dosing interval for the original product, Sandostatin®LAR.

"Considering this was a single dose study and thus there is no carry over from the previous injections, I think this is extremely encouraging. Although the patient population is still small, I would agree that it supports a 42-day dosing interval", said Professor Stafford Lightman, Professor of Medicine, University of Bristol, and Henry Wellcome Center for Integrative Neuroscience & Endocrinology (LINE), U.K. "I was impressed with the evidence that there is actually continued effect even beyond the 42 days, which suggests that when you give C2L at 42-day intervals, there should not be any significant breakthrough in the run up to the next injection," he concluded. Professor Lightman is Ambrilia's principal consultant on the C2L clinical programs and the principal investigator of the ongoing phase 3 pivotal trial.

Ambrilia's prolonged release formulation of Octreotide is currently in clinical phase 3. As announced on August 28, the Company completed patient recruitment for the pivotal efficacy study which is expected to be completed by the end of 2007.


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:

Contact Information