Ambrilia Highlights Encouraging Data for its HIV Integrase Inhibitor Program and Recent Developments at Annual Meeting
MONTREAL, QUEBEC--(CCNMatthews - June 14, 2007) - Ambrilia Biopharma Inc. (TSX:AMB), a biopharmaceutical company developing novel small molecules and peptides to treat infectious diseases and cancer, held its Annual General and Special Meeting today, during which the data reported yesterday on its novel series of HIV integrase inhibitors and recent developments were highlighted. The meeting was chaired by the new Chairman of the Board, Mr. Frederic Porte, and a progress report was presented by Mrs. Monique Letourneau, Executive Vice-President, Finance and Chief Financial Officer, followed by a scientific review presented by Dr. Bonabes de Rouge, Senior Executive Vice-President and Chief Scientific Officer.
"I would like to reiterate that the Board is committed to the success of Ambrilia. I look forward to guiding the Company as it continues to make advances in its key programs, and our productive relationship with Merck in the development of PPL-100", said Frederic Porte, Chairman of the Board of Ambrilia. "We are well advanced in the process of looking at strategic options for the Company and I believe this will enable us to be more focused as we move forward. Within the next number of months and even on into next year, our priorities will be the development of the HIV Integrase Program while bringing Octreotide and Goserelin closer to market", he concluded.
- Ambrilia's novel series of HIV integrase inhibitors were presented at the prestigious XVI International HIV Drug Resistance Workshop. These preclinical data showed their potential distinct mechanism of action, which may lead to a different resistance profile from known integrase inhibitors currently in clinical development by pharmaceutical companies. The Company is now accelerating its HIV Integrase Inhibitor Program and aims to have a drug candidate within the next 12 months.
- Co-abstract on the structural basis for PPL-100's favorable resistance profile with Merck & Co., Inc. and Dr. Mark Wainberg from McGill University, which was presented by Merck at the XVI International HIV Drug Resistance Workshop. Ambrilia continues to follow-up with Merck in their advancement of the compound towards development in HIV/AIDS patients.
- On April 24th, Ambrilia announced the positive findings of a U.S. Phase I/II study which showed that its therapeutic peptide drug PCK3145 had clinical activity in late-stage prostate cancer patients. PCK3145 was found to be safe and well tolerated, and was shown to increase PSA (Prostate Specific Antigen) doubling time and down-regulate MMP-9 (a matrix metalloproteinase enzyme involved in facilitating tumor metastasis). Disease stabilization as assessed by time to radiographic progression was also observed in several patients. Ambrilia is currently evaluating various partnering and product development strategies to move forward with PCK3145.
- The pivotal Phase III clinical trial in Europe with Octreotide in acromegaly patients was initiated in February and Ambrilia obtained an IND with its U.S. licensing partner, Mallinckrodt, to conduct a pivotal Phase III clinical trial with Octreotide. Ambrilia expects to complete the Phase III clinical efficacy study towards the end of 2007, and the safety studies around mid 2008. Filing for approval by its licensing partners is expected during the course of 2008, starting with Europe and followed by North America.
- On June 14, Ambrilia shareholders elected Mr. Richard La Rue, Vice-President, Legal Affairs and Human Resources of Ambrilia as a member of the Board.
- On June 13, the Board of Directors of Ambrilia appointed Frederic Porte, a director of the Company since January 2007, as its Chairman. Mr. Stephen G. Sudovar stepped down as a member of the Board and as its Executive Chairman, as well as interim Chief Executive Officer of the Company, for personal reasons. The search for a new President and Chief Executive Officer is still ongoing. Ambrilia's day-to-day operations continue to be managed, as usual, by the current Executive Committee.
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.
ABOUT AMBRILIA BIOPHARMA
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 a $US 17 million upfront payment,
potential milestones that could reach $US 212 million, 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: www.ambrilia.com
Posted: June 2007