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AMBRILIA REPORTS POSITIVE PHASE IA RESULTS FOR ITS LEAD
HIV/AIDS PROTEASE INHIBITOR PPL-100
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This is press release distributed by Ambrilia Biopharma.
- Results indicate PPL-100 to be a first-line, un-boosted once-a-day HIV protease inhibitor for PI-naive patients
- Results also predict PPL-100 to be an un-boosted once-a-day protease inhibitor for PI-experienced patients infected with drug resistant HIV strains containing highly prevalent mutations
- PPL-100 was very safe and well-tolerated
Montreal, June 15, 2006 - Ambrilia Biopharma Inc. (TSX:AMB), a biopharmaceutical company developing innovative therapeutics in the fields of cancer and infectious diseases, announced today positive results of a Phase Ia clinical study for PPL-100 its lead protease inhibitor (PI) for the treatment of HIV/AIDS. PPL-100 was found to be safe and well-tolerated. The pharmacokinetic (PK) profile also indicates that PPL-100 can be used as a first-line, un-boosted once-a-day (QD) protease inhibitor for PI-naive patients, and furthermore predicts (based on PPL-100's phase Ia PK profile, a long half life up to 36 hours and known single dose to steady state PK profile) that PPL-100 can also be used as an un-boosted once-a-day protease inhibitor for PI-experienced patients infected with drug resistant HIV strains containing highly prevalent mutations.
"We are very excited about the results of our single-dose study that further strengthen our confidence in PPL-100 and the difference it will make in the treatment of HIV/AIDS," said Hans J. M_der, President and Chief Executive Officer of Ambrilia. "There is an increasing need for a once-a-day protease inhibitor such as PPL-100. Furthermore, with its high genetic barrier, the fact that the mutations selected by PPL-100 do not confer cross-resistance to other PI's and our expectation that PPL-100 will not require boosting, we believe PPL-100 to be very favorably positioned as the PI of the future," he concluded.
"The data from the Phase Ia study are very promising and certainly allude to PPL-100 being a once-daily un-boosted drug to treat a broad spectrum of HIV/AIDS patients," said Professor Mark Wainberg of the McGill AIDS Centre. "Treatment regimes continue to be cumbersome, pill burden is still high, compliance as a result continues to be an issue and boosting is not preferred because of the side effects. The availability of an un-boosted QD PI would be an asset to physicians and patients in the fight against HIV/AIDS," he added.
ABOUT HIV THERAPY AND MARKET
Protease Inhibitors are a key component to the current HIV standard of care, the Highly Active Anti-Retroviral Treatment (HAART) consisting of a cocktail of reverse transcriptase inhibitors and PIs. Generally, PIs are administered in combination with a small dose of ritonavir which is used to increase (boost) the amount of available drug in the system but at the same time increases the adverse events. Most PIs are associated with side effects, a high pill burden and as it is the case with all anti-HIV drugs to some degree, virus resistance. Therefore, it is urgent to develop safe, effective PIs that possess a high genetic barrier (more difficult for the virus to develop resistance).
Despite the important advances made in antiretroviral treatments during the last decade and the recent improved access to care in many regions of the world, the AIDS epidemic claimed 3.1 million lives in 2005 and close to 5 million people were newly infected with the virus in 2005(1).
Industry reports(2) predict the Global HIV therapeutics market to exceed US$ 10 billion in 2010, the anticipated time of launch of PPL-100. Although there are several novel therapies in development, protease inhibitors will still represent 25% of this market and expected to grow significantly due to the introduction of less toxic, more efficacious drugs and more convenient dosing.
(1) AIDS epidemic update: December 2005 Joint United Nations Program on HIV/AIDS (UNAIDS) and World Health Organization (WHO) 2005
(2) Sources: Frost & Sullivan, Decision Resources, Griffin Securities
ABOUT PHASE 1a RESULTS
The Phase Ia study was a single dose escalation study evaluating the safety and pharmacokinetic profile of PPL-100 in healthy male volunteers. Evaluated were five doses of PPL-100 (300, 600, 1200, 1800 and 2400mg) in five cohorts of 8 subjects per cohort (6 receiving PPL-100 and 2 receiving placebo). Two amendments were added to the study, the first to assess the effect of combining a light meal to the 600mg and 1200mg dose; and the second to investigate the effect of combining a light meal and a low dose of ritonavir (100mg) to the 600mg dose. Subjects were again randomized to have 6 receive PPL-100 and 2 placebo. Upon completion of the study a total of 64 subjects were treated.
Results confirmed PPL-100 to be safe and well tolerated up to 2400mg with only mild (grade 1) adverse events reported for all cohorts.
The pharmacokinetic profiles were equally encouraging. The area under the curve (AUC) and maximum plasma concentrations (Cmax) indicative of the absorption and metabolism of the drug were seen to increase linearly with increasing doses. Most interesting was the long terminal mean half-life from 20 to 36 hours that give the confidence in a QD administration. Additionally, the plasma concentration at 24 hours (C24h) was still well above the inhibitory concentration (IC50, protein-binding adjusted) required to kill at least 50% of the wild type virus.
Inclusion of a light meal with both the 600mg and 1200mg doses reduces Cmax and increases Time to Maximum Plasma Concentration (Tmax) from 1 to 2 hours with no overall effect on AUC. Both Cmax and AUC were observed to increase (60%) in the 600mg dose with light meal and the co-administration of ritonavir.
ABOUT THE PLANNED PHASE Ib STUDY
The Phase Ib study, investigating safety and pharmacokinetics after repeated oral dosing with PPL-100 is planned to be initiated during the summer of 2006. The effect of both the 600mg and 1200mg doses given once daily with and without low-dose (100mg and 200mg, respectively) of ritonavir, will be evaluated. Results of this study are expected to be available in the second half of 2006.
ABOUT AMBRILIA BIOPHARMA
Ambrilia Biopharma Inc. (TSX:AMB) is a biopharmaceutical company developing innovative therapeutics in the fields of oncology and infectious diseases. Ambrilia's product portfolio includes proprietary mid to early-stage products; an anti-cancer therapeutic peptide (PCK3145), a novel anti-cancer therapy (TVT-Dox), two oncology specialty generics (Octreotide, Goserelin), the first of which is late-stage and value-added, and promising anti-HIV treatments (PPL-100, SPC3). 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
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.
INFORMATION:
Ambrilia Biopharma Inc.
Julie M. Thibodeau
Director, Communications
jthibodeau@ambrilia.com
ir@ambrilia.com
Tel.: (514) 751-2003 ext 235
www.ambrilia.com
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