October 1, 2008
Ambrilia Reports Positive Results for the Second Clinical Phase III Study of Its Octreotide Prolonged-Release Formulation C2L
Ambrilia Biopharma Inc. (TSX: AMB) today reported positive 24-week extension Phase III ("Study 302") top line results for its proprietary prolonged-release formulation of octreotide C2L. Overall, the results support the safety of C2L over an additional period of 6 months. In addition, the efficacy as measured by the mean Insulin-like Growth Factor 1 ("IGF-1") and Growth Hormone ("GH") plasma levels is maintained at the same level throughout the study period. It further confirms that octreotide C2L 30 mg every 6 weeks can replace Sandostatin(R)LAR 30 mg every 4 weeks in acromegalic patients, with the same clinical benefit and no unexpected or serious adverse effects.
"These new data further validate C2L's potential to be a safe, effective and cost effective therapy, well positioned to capture a sizeable portion of the $1 billion-plus Sandostatin(R)LAR market," said Dr. Philippe Calais, President and Chief Executive Officer of Ambrilia. "Again, we are progressing well toward our year-end divestment goal for C2L which could alleviate the Company's financial overhang by bringing non-dilutive funding."
Study 302 Top Line Results
This open label 24-week extension study evaluated the safety, clinical and biological activity of C2L 30 mg in acromegalic patients. Study 302 follows Study 301, a 24-week comparative clinical trial against Sandostatin(R)LAR ("SLAR") for which results were reported by the Company on May 14, 2008. Patients receiving SLAR for the first 84 days (12 weeks) in Study 301 received C2L for 9 additional months (36 weeks). Patients initially randomized on C2L received C2L for nearly a year.
Mean efficacy on IGF-1 was identical, throughout Study 302, to what it was after 84 days (12 weeks) of treatment in the first part of Study 301 with either C2L or SLAR. This suggests that switching from SLAR every 4 weeks to C2L every 6 weeks does not induce a decrease in IGF-1 response, even after 36 additional weeks follow-up. Efficacy on GH was also maintained throughout Study 302, again supporting that switching from SLAR every 4 weeks to C2L every 6 weeks at the same dose yields the same efficacy on GH control in acromegalics over an extended period of time.
The number of patients with normalized IGF-1 and/or GH levels was identical or slightly higher (though not significantly) after treatment with C2L as compared to SLAR.
No patient dropped out from Study 302 (all 63 patients completed the study). No serious adverse event occurred during the 24 weeks of Study 302, during which all patients were on C2L.
Overall, the top-line analysis of the results supports the ability of C2L 30 mg given every 6 weeks to replace Sandostatin LAR(R) given every 4 weeks at the same dose, with mean efficacy and safety maintained over an additional 6 months treatment.
The Company expects regulatory filings to be initiated before the end of 2008.
About Acromegaly and Octreotide C2L
Acromegaly is a rare and serious condition related to the hypersecretion of growth hormone by the pituitary gland, generally of tumoral origin. This causes an uncontrolled growth of organs, debilitating symptoms and a shorter life expectancy. Pharmacotherapy with somatostatin analogs is one of the treatment options, a life-long treatment with a few and mild side effects. Novartis' Sandostatin(R) (octreotide) is the market leader and which efficacy is clearly established for treating acromegaly. The yearly treatment with the long-acting release (LAR) formulation of the product, which consists of intramuscular injections every 4 weeks, is costly. Difficult reconstitution prior to injection is also an issue.
Ambrilia has developed an improved, proprietary prolonged release formulation of Octreotide (C2L) for which Phase III results have indicated its ability to replace Sandostatin LAR(R) with less frequent injections and non inferior efficacy, and comparable safety. C2L is easier to reconstitute and could be the first therapeutic alternative to Sandostatin(R)LAR.
AMBRILIA'S FORWARD-LOOKING STATEMENTS
This press release contains forward-looking statements that reflect the Company's current expectation regarding future events. There is a risk that expectations and forward looking statements will not prove to be accurate. Readers are cautioned not to place undue reliance on these forward-looking statements as they involve risks and uncertainties, which could make actual results 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 annual information form which contains 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.
ABOUT AMBRILIA BIOPHARMA
Ambrilia Biopharma Inc. (TSX: AMB) is a biotechnology company focused on the discovery and development of novel treatments for viral diseases and cancer. The Company's strategy aims to capitalize on its broad portfolio and original expertise in virology. Ambrilia's product portfolio is comprised of oncology and antiviral assets, including two new formulations of existing peptides for cancer treatment, a therapeutic peptide for prostate cancer, a targeted delivery technology for cancer, an HIV protease inhibitor program (exclusive worldwide rights granted to Merck & Co., Inc.) as well as HIV integrase and entry inhibitors, Hepatitis C virus inhibitors and anti-Influenza A compounds. 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
Contacts: Ambrilia Biopharma Inc. Dr. Philippe Calais, Ph.D., Pharm. President & CEO 514-751-2003 ext 230 [email protected]www.ambrilia.com
SOURCE: Ambrilia Biopharma Inc.