Prana Completes Recruitment in Huntington Trial

Prana Completes Recruitment in Huntington Trial 
6 Month Phase II Study With PBT2 in Huntington Patients 
MELBOURNE, AUSTRALIA -- (Marketwire) -- 12/19/12 --  Prana
Biotechnology (NASDAQ: PRAN) (ASX: PBT) today announced that it has
completed recruitment in the Reach2HD Phase IIa clinical trial using
PBT2 in patients with Huntington Disease (HD).  
The 6 month double-blind, placebo-controlled Phase II trial in
patients with early to mid-stage Huntington Disease met its enrolment
target of 100 patients ahead of schedule. Additional patients may be
included in the trial, subject to final procedures this week. 
The Principal Investigator on the study, Dr. Ray Dorsey of Johns
Hopkins University Medical Center, commented that "interest in PBT2
is high in part because PBT2 offers a novel mechanistic approach to
the treatment of HD. We thank the clinical sites and the Huntington
community for their wonderful support." The Reach2HD trial was
coordinated in conjunction with the Huntington Study Group (HSG)
across 20 clinical sites in the USA and Australia.  
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. At this time there is only one marketed drug
for the alleviation of some of the involuntary motor symptoms
associated with the disease. 
Professor Ira Shoulson, Professor of Neurology, Pharmacology and
Human Science at Georgetown University (Washington DC) and the Chair
of the Executive Committee of the Huntington Study Group said, "PBT2
attracted our attention as an experimental drug with the potential to
bring real benefit to Huntington Disease patients who suffer from a
range of motor, behavioural and cognitive symptoms. The favourable
signals from the PBT2 trial in Alzheimer's Disease are particularly
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. In this trial,
Prana is studying the safety and tolerability of PBT2 in Huntington
patients and investigating potential benefits in cognition, motor
coordination, behavioural, functional and psychiatric effects. In
addition the trial will pilot biomarker and imaging assessments. The
protocol synopsis appears below in Appendix 1. 
Appendix 1 - Protocol synopsis 

Title           A randomized, double-blind, placebo-controlled study to     
                assess the safety and tolerability, and efficacy of PBT2 in 
                patients with early to mid-stage Huntington disease (HD)    
Study Number    PBT2-203                                                    
 Name/Acronym   Reach2HD                                                    
Study Design    Randomised, double-blind, placebo-controlled, parallel      
                group, multi-centre, Phase 2a study.                        
Objectives      Primary objective:                                          
                To evaluate the safety and tolerability of two dose levels  
                of PBT2 when administered orally once daily over 26 weeks in
                patients with HD.                                           
                Secondary objectives:                                       
                Determine the effect of PBT2 after 26 weeks in patients with
                HD on:                                                      
                1. Cognition                                                
                2. Motor function                                           
                3. Behavior                                                 
                4. Functional abilities                                     
                5. Global function                                          
                6. Plasma and urine biomarkers                              
                7. Brain volumes and function (imaging), and                
                8. To evaluate the Pharmacokinetics of PBT2 in patients with
Number of                                                                   
 Patients       100 patients (original target)                              
Key Patient      -- Men and women with Total Functional Capacity (TFC) 6-13,
 Criteria       inclusive, and a CAG repeat number of ≥ 36            
                 -- Montreal Cognitive Assessment (MoCA) score ≥ 12   
Doses           Placebo (0mg PBT2), 100mg PBT2 and 250mg PBT2, once daily   
Per Patient     34 weeks:  Four week Screening period, 6 months (26 weeks)  
 Duration       treatment period and Follow-up 4 weeks post treatment.      
Endpoints       Primary                                                     
                 -- Safety and Tolerability assessments.                    
                 -- Cognition Tests: Cognitive Test Battery (consisting of  
                Category Fluency Test, Trail Making Test parts A and B, Map 
                Search, Symbol Digit Modalities Test and Unified Huntington 
                Disease Rating Scale (UHDRS) Stroop Word Reading). MoCA.    
                 -- Motor Function Tests: UHDRS '99 Motor component; Speeded
                Tapping Task.                                               
                 -- Behavior: UHDRS Behavioral component.                   
                 -- Functional Abilities: Total Functional Capacity and     
                Independence Scale from UHDRS '99; Schwab & England         
                Activities of Daily Living Scale (SEADL).                   
                 -- Subject and investigator global assessments: Patient    
                Reported Outcomes; Clinical Global Impression - Severity    
                 -- Biomarkers: small molecule markers of metabolic and     
                oxidative stress in blood and urine; blood levels of total  
                and mutant huntingtin; gene expression markers of HD        
                progression; plasma selenium.                               
                 -- Brain Imaging: volumetric and functional measures.      
                 -- Pharmacokinetics: sparse sampling.                      
Trial Locations  -- Australia                                               
                 -- USA                                                     
Trial Standard  Study being conducted according to ICH GCP                  

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 
The Huntington Study Group 
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 PBT2, 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.  
Prana Biotechnology Ltd
T: +61 3 93494906
US - Investor Relations
Leslie Wolf-Creutzfeldt
T: 646-284-9472
US - Media
Ivette Almeida
T: 646-284-9455
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