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Prana Provides Clinical Trials Safety and Progress Update

Prana Provides Clinical Trials Safety and Progress Update 
Alzheimer's and Huntington Disease Trials on Track 
MELBOURNE, AUSTRALIA -- (Marketwired) -- 04/03/13 --   Prana
Biotechnology (NASDAQ: PRAN) (ASX: PBT) today reported on the
progress of its lead development asset PBT2 in Phase II trials for
Huntington disease and Alzheimer's disease. Across the two trials
approximately 37% have been dosed to 6 months or longer, twice the
duration of the previous Phase II Alzheimer's trial.(1,2) PBT2 has
been well tolerated and both trials are on schedule with very
pleasing retention rates and compliance. Each Independent Data Safety
Monitoring Board for the two trials met at the end of March and
recommended that each trial continue as planned without any protocol
changes.  
Prana's PBT2 represents a novel and differentiated therapeutic action
in the treatment of neurodegenerative diseases based on its
specialized ability to prevent the toxic relationship between disease
proteins and biological metals in the brain which otherwise can lead
to protein amyloid formation. Moreover, the redistribution of such
metals by PBT2 promotes neurotransmission and neuronal function. 
Alzheimer's disease Trial Update - the "IMAGINE" trial 
In an earlier 12 week trial PBT2 both significantly changed amyloid
levels in spinal fluid and improved the cognition of patients with
Alzheimer's disease.(1,2) The IMAGINE trial, with 12 months of
treatment, aims to establish PBT2 as a safe and effective treatment
for Alzheimer's disease. The following provides an update on the
trial: 


 
--  Last Patient recruited November 2012;
--  Last Patient to be Dosed November 2013;
--  Trial will be completed in December 2013;
--  7% of patients have completed 12 months of dosing, over 4 times longer
    than the previous longest exposure to PBT2;
--  50% of patients have reached 26 weeks of dosing;
--  Data Safety Monitoring Board met on 27 March, 2013, with the
    recommendation to continue the trial without any changes to the
    original protocol.

  
The randomized, double-blind, placebo controlled trial has enrolled 41
patients with prodromal or mild Alzheimer's disease in five sites in
Melbourne, Australia. Brain Imaging is being used to measure PBT2's
effect on amyloid deposits in th
e brain (using PiB-PET scanning) and
effects on increasing brain activity (FDG PET). Cognition effects are
being measured by the Neuropsychological Test Battery (NTB).  
The trial has received funding from the Alzheimer's Drug Discovery
Foundation (ADDF). 
Howard Fillit, MD, the ADDF's Executive Director commented, "PBT2
stands out as one of the few orally available agents with clinical
trial evidence of cognitive benefit for Alzheimer's patients. Success
in this trial will demonstrate target engagement by PBT2 in the brain
of people with Alzheimer's disease, and accelerate the clinical
development of PBT2 to patients." 
The protocol for the IMAGINE trial is available by clicking here.  
Huntington Disease Trial Update - the "Reach2HD" trial 
The Reach2HD trial is a 6 month trial in 109 patients with early to
mid-stage Huntington disease. The trial is being conducted across
sites in the USA and Australia. The following provides an update on
the trial: 


 
--  Last Patient recruited December 2012;
--  Last Patient to be Dosed June 2013;
--  Results anticipated October 2013;
--  97% of patients have completed 12 weeks of dosing (equal to previous
    longest exposure of PBT2);
--  32% of patients have completed 6 months of dosing;
--  Data Safety Monitoring Board met on 28 March, 2013, with the
    recommendation to continue the trial without any changes to the
    original protocol.

  
Only one drug is marketed for Huntington disease and that is only for
the relief of the severe motor or chorea symptoms. There are no
approved treatments for the significant cognitive and behavioural
components of the disease, which typically manifest before motor
problems. 
The protocol and site updates for the Reach2HD trial can be accessed
by clicking here. 
References 
(1.) Lannfelt et al. Lancet Neurology (2008) vol. 7, pp. 779-86;  
(2.) Lannfelt et al. Erratum: Lancet Neurology (2009) vol. 8, pp.
981.  
About Prana Biotechnology Limited
 Prana Biotechnology was
established to commercialize research into age-related
neurodegenerative disorders. The Company was incorporated in 1997 and
listed on the Australian Securities 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 of Harvard Medical School, contributed to the
discovery of Prana's technology.  
For further information please visit the Company's web site at
www.pranabio.com. 
About Huntington disease
 Huntington disease is a complex and
severely debilitating genetic, neurodegenerative disease, for which
there is no cure. The disease often affects young adults and, whilst
associated with severe physical movement symptoms, progressively
impacts the mind and emotions as well. The disease causes
incapacitation and death about 15-25 years after onset. The disease
affects 30,000 people in the US and about 70,000 worldwide. There are
no drugs in development that have established clinical evidence for
treating cognitive decline. 
About the Alzheimer's Drug Discovery Foundation 
 The Alzheimer's
Drug Discovery Foundation (ADDF) is the only non-profit organization
whose sole mission is to accelerate the discovery and development of
drugs to prevent, treat and cure Alzheimer's disease, related
dementias and cognitive aging. Since 1998, the ADDF has granted more
than $50 million to fund over 325 Alzheimer's drug discovery programs
in academic centers and biotechnology companies in 18 countries. For
more information about the Foundation, please visit
www.AlzDiscovery.org. 
Forward Looking Statements 
 This 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, but not limited to, PBT2, that could slow or prevent
products coming to market, the uncertainty of patent protection for
the Company's intellectual property or trade secrets, including, but
not limited to, the intellectual property relating to P
BT2, and other
risks detailed from time to time in the filings the Company makes
with Securities and Exchange Commission including its annual reports
on Form 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. 
Contacts:
Australia
Prana Biotechnology
+61 3 9349 4906 
US
Leslie Wolf-Creutzfeldt
T: 646-284-9472
E: leslie.wolf-creutzfeldt@grayling.com 
Media:
Ivette Almeida
T: 646-284-9455
E: Ivette.almeida@grayling.com 
 
 
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