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Prana Announces Success in Phase IIa Clinical Trial of PBT2 in Early Alzheimer's Disease PBT2 demonstrates positive biomarker and cognitive effects

Key Takeaway: Announces Success in Phase IIa Clinical Trial of PBT2 in Early Alzheimer's demonstrates positive biomarker and cognitive effects Australia - February 26, 2008: Prana Biotechnology Limited (NASDAQ: PRAN / biopharmaceutical company focused on the research and development of trea

Full Press Release Details

Announces Success in Phase IIa Clinical Trial of PBT2 in Early Alzheimer's
demonstrates positive biomarker and cognitive effects
Australia - February 26, 2008: Prana Biotechnology Limited (NASDAQ: PRAN /
biopharmaceutical company focused on the research and development of treatments
for neurodegenerative disorders, today announced that PBT2 has demonstrated
safety and tolerability and reduced Abeta 42, in a Phase IIa study of PBT2
patients with early Alzheimer's Disease. PBT2 also improved Executive Function
performance in select cognitive tests.
a very exciting and important milestone for the company, particularly because
PBT2, a drug known to inhibit the toxic oligomers of Abeta that cause the
functional damage in Alzheimer's Disease, was able to show such a clear effect
in a short trial," commented Geoffrey Kempler, Prana's Chairman and CEO.
double blind multi-centre clinical trial, 78 patients in Sweden and Australia
were randomized to receive either a placebo, PBT2 50mg or PBT2 250mg capsule
once per day for 12 weeks.
of the trial data demonstrated that the safety and tolerability profile of
at both doses was indistinguishable from that of placebo. There were no study
withdrawals related to adverse events. There was no serious adverse event (SAE)
in any PBT2 treated patient.
also demonstrated the impact of PBT2 on reducing Abeta 42 in the cerebrospinal
fluid (CSF) that surrounds the brain and spinal cord, considered a key biomarker
for Alzheimer's Disease. Specifically, PBT2 at the 250mg dose showed a highly
significant reduction in CSF Abeta 42 compared to placebo (p=0.006). The effect
of PBT2 was dose related (p=0.02).
Jeffrey Cummings, Director of the Easton Centre for Alzheimer's Disease at UCLA,
and Head of Prana's Research and Development Advisory Board, commented that
"PBT2 has hit what we consider to be the critical target for Alzheimer's
Disease, as evidenced by the significant reduction in Abeta 42."
signs of cognitive improvement, as measured by the Neuropsychological Test
Battery (NTB), were also observed. Statistically significant improvement was
evident in two of the four Executive Function NTB tests: the Category Fluency
Test (p=0.028) and the Trail Making Test part B (p=0.005), both after 12 weeks
of treatment at the 250mg dose compared to placebo. PBT2, in this study of
disease progression, had no effect on ADAS-cog, a test of cognition not designed
to measure Executive Function changes. The NTB is a test of cognition that
more sensitive to the changes in Executive Function that are seen in the early
stage of Alzheimer's Disease.
impact of this drug on Executive Function is very encouraging as this is likely
to predict an improvement in the day to day functioning in the lives of people
with Alzheimer's Disease. The ability to plan and execute everyday activities,
even more so than memory, offers great practical and clinical benefit to
patients" added Professor Cummings.
results build on earlier observations using PBT2 in transgenic mouse models
Alzheimer's Disease, where PBT2: reduced toxic oligomers of Abeta, reversed the
Abeta-induced loss of neurotransmission and improved cognition.
plans to further progress PBT2 into larger and longer clinical trials to
investigate its potential as a disease modifying drug.
very hopeful that PBT2 will continue to perform as well as it has in this trial
and progress through the development pathway, eventually to bring true benefit
to patients with Alzheimer's Disease. PBT2 is one of many Metal Protein
Attenuating Compounds (MPACs) within the Prana pipeline, which we are
enthusiastic to develop for a range of neurodegenerative diseases," concluded
refer to the Appendix below which is included in, and forms part of, this
company will hold a conference call to discuss the above results and welcomes
participation from interested parties.
from the US or Canada (toll-free)
from other locations
in at least 10 minutes prior to commencement to access
Prana or conference ID # 64631038
will be webcast and available on the Prana website www.pranabio.com
of the call will be available 2 hours later until 11.59pm (US eastern time)
888-286-8010 from the US or Canada (toll - free) or +1 617-801-6888 from other
locations.To enter conference dial ID # 16766828
Prana Biotechnology Limited
Biotechnology was established to commercialize research into Alzheimer's Disease
and other major age-related neurodegenerative disorders. The Company was
incorporated in 1997 and listed on the Australian Stock Exchange in March 2000
and listed on NASDAQ in September 2002. Researchers at prominent international
institutions including The University of Melbourne, The Mental Health Research
Institute (Melbourne) and Massachusetts General Hospital, a teaching hospital
Harvard Medical School, contributed to the discovery of Prana's technology.
further information, please visit the Company's web site at
press release contains "forward-looking statements" within the meaning of
section 27A of the Securities Act of 1933 and section 21E of the Securities
Exchange Act of 1934. The Company has tried to identify such forward-looking
statements by use of such words as "expects," "intends," "hopes," "anticipates,"
"believes," "could," "may," "evidences" and "estimates," and other similar
expressions, but these words are not the exclusive means of identifying such
statements. Such statements include, but are not limited to any statements
relating to the Company's drug development program, including, but not limited
to the initiation, progress and outcomes of clinical trials of the Company's
drug development program, including, but not limited to, PBT2, and any other
statements that are not historical facts. Such statements involve risks and
uncertainties, including, but not limited to, those risks and uncertainties
relating to the difficulties or delays in financing, development, testing,
regulatory approval, production and marketing of the Company's drug components,
including, but not limited to, PBT2, the ability of the Company to procure
additional future sources of financing, unexpected adverse side effects or
inadequate therapeutic efficacy of the Company's drug compounds, including,
not limited to, PBT2, that could slow or prevent products coming to market,
uncertainty of patent protection for the Company's intellectual property or
trade secrets, including, but not limited to, the intellectual property relating
to PBT2, and other risks detailed from time to time in the filings the Company
makes with Securities and Exchange Commission including its annual reports
From 20-F and its reports on Form 6-K. Such statements are based on management's
current expectations, but actual results may differ materially due to various
factions including those risks and uncertainties mentioned or referred to in
this press release. Accordingly, you should not rely on those forward-looking
statements as a prediction of actual future results.
Investor Relations Media Relations
Leslie Wolf-Creutzfeldt Ivette Almeida
T: 646-284-9472 T: 201-232-0128
E: lcreutzfeldt@hfgcg.com E: ialmeida@hfgcg.com
Jillian Wanner Stacy Dimakakos
T: 646-284-9422 T: 646-284-9417
E: jwanner@hfgcg.com E: sdimakakos@hfgcg.com
Last updated: Feb 26, 2008