Ambrilia Biopharma Inc.: Termination of Study 303 and Update On C2L Development
MONTREAL, QUEBEC--(Marketwire - July 24, 2009) - Ambrilia Biopharma Inc. (TSX:AMB) announced today that its Board of Directors has approved the termination of the phase III clinical Study 303 as part of ongoing measures to effectively reduce costs. Study 303 involves clinical centers in both Europe and the USA and was designed to evaluate the 30mg, 20mg and 10mg dosage forms of Ambrilia's octreotide acetate (C2L) in acromegalic patients. All patients enrolled in Study 303 reached the 6-month visit and there were no adverse effect or safety concerns. Ambrilia, through various partners, is continuing with its regulatory filings process and discussions, utilizing the results from earlier studies completed namely, 301 and 302. Top line results of Study 302, an open label extension of Study 301 in which all patients were administered C2L, were previously announced. Analysis following the 24-week extension treatment period provided longer term safety data (up to one year on C2L) as well as supportive efficacy data. A decision was recently taken not to collect further data in this group of patients.
About Ambrilia Biopharma Inc.
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 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 targeted delivery technology for cancer, an HIV protease inhibitor program 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. 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. 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. Failure to complete a strategic or financial transaction as a result of the review of strategic alternatives could have a material adverse effect on Ambrilia. 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.
CONTACT INFORMATION: Ambrilia Biopharma Inc. Dr. Philippe Calais, Ph.D., Pharm. President & CEO 514-751-2003 ext 230 [email protected] www.ambrilia.com