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Prana Provides Clinical Trials Update: Alzheimer’s and Huntington disease trials on track

Melbourne – 22 August, 2012; Prana Biotechnology (NASDAQ:PRAN; ASX:PBT) today reported on its progress in its Phase II clinical trials with its lead development asset PBT2. PBT2 has a unique therapeutic action that can benefit people suffering neurodegenerative disease because of its specialized ability to prevent the toxic relationship between disease proteins and biological metals in the brain.

Prana’s world leading work in neurodegenerative diseases is capturing significant international recognition, particularly at a time when other potential treatments are failing. "There is mounting evidence that compounds that can restore metal homeostasis in the neuron can stop and even reverse cognitive decline associated with neurodegenerative diseases. We think Prana's PBT2 could be such a compound," said New York based MLV & Co. Equity Research, Senior Biotech Analyst George Zavoico, Ph.D. The full report is available at www.pranabio.com.

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:

100% of sites approved and open for recruitment;
40% of patients in dosing;
Recruitment On Track to report 2H13;
3 patients have reached 24 weeks of dosing – doubling the previous longest exposure to PBT2;

No serious adverse events reported; and
First Data Safety Monitoring Board meeting in September 2012, reporting on safety and tolerability.

The randomized, double-blind, placebo controlled trial is enrolling 40 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 the 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 results of the IMAGINE trial will be closely watched by the Alzheimer’s community, given the recent failure of several late-stage therapeutic candidates. We believe that PBT2’s mechanism of action explains the clinical benefits that the drug has already shown, and we anticipate positive results from this trial,” said Chief Executive Officer, Mr Geoffrey Kempler.

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 100 patients with early to mid-stage Huntington disease. An IND was opened to conduct the trial across sites in the USA and Australia. The following provides an update on the trial:

70% of sites approved and open for recruitment; 14% patients in dosing;
Recruitment On Track to report 2H13;
No serious adverse events reported; and

First Data Safety Monitoring Board meeting in October 2012, reporting on safety and tolerability.

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 promising.”

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 trial objective is to demonstrate safety, motor and behavioural benefits and the same cognitive benefits for Huntington’s patients that it has already demonstrated in Alzheimer’s patients treated with PBT2,” said Mr Kempler.

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.

Lannfelt et al. Lancet Neurology (2008) vol. 7, pp. 779-86; Lannfelt et al. Erratum: Lancet Neurology (2009) vol. 8, pp. 981