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Prana results out. Some cognition improvement.
Prana Announces Success in Phase IIa Clinical Trial of PBT2 in Early
Alzheimer’s Disease
PBT2 demonstrates positive biomarker and cognitive effects
MELBOURNE, Australia – February 26, 2008: Prana Biotechnology Limited
(NASDAQ: PRAN / ASX: PBT), a 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 in patients with early Alzheimer’s Disease. PBT2 also improved Executive
Function performance in select cognitive tests.
“This is 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.
In this 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.
Analysis of the trial data demonstrated that the safety and tolerability profile of PBT2 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.
The study 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).
Professor 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.”
Encouraging 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 early 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 is more sensitive to the
changes in Executive Function that are seen in the early stage of Alzheimer’s Disease.
“The 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.
These results build on earlier observations using PBT2 in transgenic mouse models of
Alzheimer’s Disease, where PBT2: reduced toxic oligomers of Abeta, reversed the
Abeta-induced loss of neurotransmission and improved cognition.
Prana now plans to further progress PBT2 into larger and longer clinical trials to
investigate its potential as a disease modifying drug.
“We are 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 Mr. Kempler.
Please refer to the Appendix below which is included in, and forms part of, this
announcement.
Conference call details:
The company will hold a conference call to discuss the above results and welcomes
participation from interested parties.
Australia
Wednesday, February 27, 2008
9.00am(Eastern Summer Time)
Dial in number:
1800-002-971
USA
Tuesday, February 26, 2008
5.00pm (US Eastern time)
Dial in number:
888-713-4218 from the US or Canada (toll-free)
or [phone] from other locations
Dial in at least 10 minutes prior to commencement to access call
Reference Prana or conference ID # 64631038
The call will be webcast and available on the Prana website www.pranabio.com
REPLAY OF TELECONFERENCE
A replay of the call will be available 2 hours later until 11.59pm (US eastern time) on March 3, 2008.
Dial + 1 888-286-8010 from the US or Canada (toll – free) or
ee) or [phone] from other
locations.To enter conference dial ID # 16766828