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MONTREAL, QUEBEC--(CCNMatthews - June 20, 2006) –
At its Annual
General Meeting today, Ambrilia Biopharma Inc. (TSX:AMB),
a biopharmaceutical company developing innovative therapeutics
in the fields of cancer and infectious diseases, highlighted the
positive Phase Ia results for its lead HIV protease inhibitor
PPL-100 and the latest developments in its product portfolio.
The meeting was chaired by the Board Chairman, Dr. Max Link,
and a progress report was presented by Mr. Hans J. Mader,
President and Chief Executive Officer, with financial highlights
presented by Mrs. Monique Letourneau, Executive Vice-President,
Finance and Chief Financial Officer and a scientific review
presented by Dr. Bonabes de Rouge, Senior Executive Vice-President
and Chief Scientific Officer. Main highlights of the meeting were
the following:
PPL-100, A POTENTIAL FIRST-LINE HIV TREATMENT
- Reported Phase 1a, single-dose study results with PPL-100:
- Safety results confirmed PPL-100 to be very safe and well
tolerated up to 2400mg without any significant adverse events,
only mild adverse events (Grade 1) were observed in all
cohorts.
- Pharmacokinetic (PK) results suggest PPL-100 to be a potential,
first-line, un-boosted (without ritonavir co-administration),
once-a-day HIV protease inhibitor (PI) in PI-naive patients.
- Based on PPL-100's PK profile, its long half-life of over 24
hours and expected single-dose to steady state PK ratio, PPL-
100 could have the potential to be an un-boosted, once-a-day PI
for treatment experienced patients.
- Announced final results of an "in vivo" resistance study confirming
PPL-100's high genetic barrier (more difficult for the HIV virus to
develop resistance) and virtually no-cross resistance to other PIs
(amprenavir, lopinavir, atazanavir, saquinavir, indinavir and
nelfinavir). These results were presented at the prestigious XV
International HIV Drug Resistance Workshop.
- Plan to initiate Phase Ib study, investigating safety and
pharmacokinetics after repeated oral dosing (steady state) with
PPL-100 during the summer of 2006. Results of this study are
expected to be available in the second half of 2006.
- Out-licensing discussions for PPL-100 are actively ongoing.
OCTREOTIDE, ONCOLOGY SPECIALTY GENERIC FOR ACROMEGALY
- Effectively implemented sterile manufacturing chain in Ambrilia's
Montreal facilities allowing the production of batches in
compliance with cGMP (Good Manufacturing Practice) regulations
(Canada / USA / Europe). Six batches were already produced with
excellent consistency and expected yields reached.
- Initiated the pivotal PK study in healthy volunteers to demonstrate
bioequivalence for Octreotide according to Europe/Canada and U.S.
recommendations. This will be followed by a European and Canadian
multi-center study in acromegaly patients expected to begin in the
second half of 2006.
- Plan to complete European and U.S. regulatory filings in the course
of 2007 for an expected launch in most countries in 2008.
PCK3145, A THERAPEUTIC ANTI-CANCER PEPTIDE FOR ADVANCED METASTATIC
PROSTATE CANCER
- Received U.S. patent for signal transduction inhibitor PCK3145 and
63 related sequences on May 30, 2006
"We are pleased with the advancements made in our lead development
programs, especially with PPL-100's Phase 1a results as we believe
the market potential of this drug candidate, a potential first-line,
once-a-day, un-boosted treatment for HIV/AIDS, is tremendous. These
positive results step up the current discussions we are having with
potential partners and we look forward to concluding an out-
licensing agreement prior to the first half of 2007" said Mr.
Hans J. Mader, President and Chief Executive Officer of Ambrilia.
"We are happy to reiterate that we are on track to meet the
corporate milestones we've set for the year 2006 and I believe
attainment of these are key to increasing Ambrilia's market
valuation, visibility on the financial markets as well as
solidifying investor confidence" he concluded.
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.
FOR FURTHER INFORMATION PLEASE CONTACT:
Ambrilia Biopharma Inc.
Julie M. Thibodeau
Director, Communications
(514) 751-2003 ext. 235
jthibodeau@ambrilia.com or ir@ambrilia.com
www.ambrilia.com
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