Full Press Release Details
Further Information - Prana's PBT2
Clinical Trials Cited as Most
Advanced in Addressing Neurodegeneration
Equilibrium Perspective
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 Year-End".*
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 mid-stage 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.
Forward Looking Statements
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.
Leslie Wolf-Creutzfeldt