Further Information – Prana’s PBT2 Clinical Trials Cited as Most Advanced in Addressing Neurodegeneration from the Metal Equilibrium Perspective

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Melbourne – September 20, 2012; Prana Biotechnology (NASDAQ:PRAN;
ASX:PBT) today reported that it had been cited in an interview in The Life Sciences
Report with George Zavoico, Ph.D., senior equity analyst and managing director with
MLV & Co., as the only drug company to address in clinical trials the control of transition
metal levels in neuronal synapses, a key event in age-related dysfunction of the brain.
The Report citing Prana is titled, “Seven Innovative Biotechs That Could Soar By YearEnd”.*
Further information regarding MLV & Co & Prana is provided below.**
In the published interview, Dr. Zavoico spoke about an emerging hypothesis addressing
the formation of beta amyloid plaques, and how another neuronal protein, tau, is
hyperphosphorylated, enabling it to form neurofibrillary tangles. These are recognized by
experts in the field as key events in age-related brain dysfunction and cognitive loss.
The basis for what has been called the “Metals Dyshomeostasis Hypothesis” is the
abnormal distribution and loss in the control of transition metal levels in neuronal
synapses. Dr. Zavoico said, “Metals like zinc, copper and iron have a number of
important biologic functions, most notably in the function of numerous enzymes and
receptors. Zinc, in particular, binds to beta amyloid, leading to its aggregation and,
ultimately, plaque formation”.
Moreover, studies have shown that abnormal distribution of transition metals driven
partly by beta amyloid plaque formation affects the function of tau, an intracellular
protein essential for normal neuronal function. Tau becomes hyperphosphorylated and
forms neurofibrillary tangles, which is thought to cause neuronal cell death.
Prana is evaluating the potential clinical benefit of PBT2 in two Phase II trials in two
different neurodegenerative diseases. In Alzheimer’s disease, the IMAGINE trial, a
double-blind placebo controlled trial enrolling 40 patients with prodromal or mild
Alzheimer’s disease, being treated for 12 months will test cognition and use brain
imaging to measure the effects of PBT2 on beta-amyloid deposits in the brain and
effects on increasing brain activity

In the interview, Dr. Zavoico added: “In preclinical studies, Prana’s lead drug candidate,
PBT2, has been shown to redistribute zinc and other transition metals, preventing beta
amyloid aggregation and even inducing its disaggregation. Sequestration of zinc in beta
amyloid plaques reduces zinc levels inside the neuron, which can lead to its [tau
protein’s] hyperphosphorylation. The metals hypothesis appears to unify the pathology
underlying both amyloid plaque and neurofibrillary tangle formation, which makes this
approach so compelling, in my mind”.
Notably, Huntington’s disease is also characterized by misfolding and aggregation of
proteins, but of Huntingtin protein, not beta amyloid. Like Alzheimer’s, studies indicate
that the pathology underlying Huntington’s disease is also due to abnormal distribution of
certain transition metals. The Reach2HD trial, enrolling 100 patients with early to midstage Huntington’s disease, being treated for 6 months, aims 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. Results of
Prana’s clinical trials are expected in the second half of next year.
Prana’s CEO, Geoffrey Kempler, commented that “it is very encouraging that the
strength of our science and the clinical potential of PBT2 is being recognized by industry
experts and analysts, particularly at a time when so many competing drug candidates to
treat Alzheimer’s have failed to meet their clinical endpoints. As some researchers are
losing hope that Alzheimer’s can even be treated, we remain very confident in the
potential of PBT2 to help patients”.
*The Life Sciences Report, A Streetwise Report, September 13, 2012.
**: The Life Sciences Report, A Streetwise Report interview with Dr Zavoico follows an
Equity Research Life Sciences Biotechnology Company Update of MLV & Co LLC dated
August 10, 2012. A copy of the initial report is available on the Company’s website
at www.pranabio.com. MLV & Co LLC is a New York based full service investment
bank which, as previously announced, has acted and continues to act and receive fees
as a broker to the Company.
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.

 

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