Ambrilia Biopharma Inc.

Ambrilia Biopharma Inc.

December 08, 2006 08:50 ET

Ambrilia Announces that Phase 1 Study Results Support Continued Development of PPL-100, an Investigational HIV/AIDS Protease Inhibitor


MONTREAL, QUEBEC--(CCNMatthews - Dec. 8, 2006) - Ambrilia Biopharma Inc. (TSX:AMB), a biopharmaceutical company developing innovative therapeutics in the fields of cancer and infectious diseases, announced today the outcome from the Phase 1 repeat dose study with PPL-100, its lead investigational protease inhibitor (PI) for the treatment of HIV/AIDS.

The study showed that PPL-100 has a good safety profile, with only mild (grade 1) adverse events observed in the treatment groups. No moderate or severe cardiovascular and hepatic adverse effects, characteristic of the class of compounds, were observed and no clinically significant abnormalities were observed in laboratory safety tests.

The pharmacokinetic (PK) data from the current repeat dose study support the potential for PPL-100 either as an un-boosted once-daily or twice-daily treatment for PI-naive and treatment-experienced HIV/AIDS patients.

In October, Merck & Co., Inc. signed an exclusive licensing agreement with Ambrilia granting Merck, through an affiliate, worldwide rights to Ambrilia's protease inhibitor program, including PPL-100. Based upon the results of the repeat dose study, Merck has commenced an active formulation program to further improve the pharmacokinetic profile of the compound and move the program forward. To date, PPL-100 has been administered as capsules with neat unformulated compound. Because of this formulation development at Merck, the $US 3 million milestone expected by Ambrilia with the Phase 1 repeat dose results will not be received. Nevertheless, all subsequent milestones will not be affected.

"We are pleased with the results from our Phase 1 repeat dose study that confirm our original expectations and belief in PPL-100," said Hans J. Mader, President and Chief Executive Officer of Ambrilia. "We look forward to following the progress made by Merck as it moves the compound through improved formulation and further clinical development," he added.


Protease Inhibitors (PIs) are a key component of the current HIV standard of care, the Highly Active Anti-Retroviral Therapy (HAART), consisting of combinations of anti-HIV agents. Unfortunately, many PIs are associated with side effects, a high pill burden and, as it is the case with all anti-HIV drugs, the development of viral resistance. In addition, the majority of PIs are administered in combination with a small dose of ritonavir, another protease inhibitor that is often used to increase, or boost, the amount of available drug in the system, but which also has the potential to increase adverse events. More than ever, there is a pressing need for better tolerated, more convenient and effective PIs.


Ambrilia Biopharma Inc. (TSX:AMB) is a biopharmaceutical company developing innovative and proprietary early to mid-stage therapeutics in the fields of oncology and infectious diseases. Ambrilia's product portfolio includes an anti-cancer therapeutic peptide (PCK3145), a Tumor Vasculature Targeting (TVT) technology platform, an improved, prolonged release formulation of Octreotide, a new formulation of Goserelin, promising anti-HIV treatments (PPL-100, HIV Integrase Inhibitor Program), other anti-virals and immunomodulators. 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:

Ambrilia's forward-looking statements

This press release contains forward-looking statements that reflect the Company's current expectation regarding future events. The 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. 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.

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