Regulatory Approval To Start PBT2 Phase IIa Clinical Trial In Alzheimer's Disease Patients

Prana Biotechnology Limited (Nasdaq: PRAN; ASX: PBT), today announced that it has
received regulatory approval from Sweden's Medical Products Agency (MPA) to
start a Phase IIa clinical trial of its proprietary lead compound, PBT2, in
patients with early Alzheimer's disease. The trial will be conducted in
seven centres in Sweden.



The study, which will commence next month, will evaluate the safety and
tolerability of PBT2. In addition, it will examine the drug's mechanism of
action and indicators of potential efficacy in treating Alzheimer's
disease. Results are expected to be announced in the fourth quarter of
2007.



"The earlier clinical finding with PBT1 (Prana's proof-of-concept
compound), together with our recently announced data that there is a rapid
and potent onset of benefits in transgenic mice treated with PBT2, leads us
to believe that we may see biochemical, and possibly cognitive, benefit in
the relatively short time frame of our Phase IIa trial of mildly affected
patients. The best hope is that in the course of its development PBT2 could
be shown to be disease modifying, offering real hope to Alzheimer's disease
patients. Currently there are no approved disease modifying treatments
available to patients," stated Professor Colin Masters of the University of
Melbourne and the Mental Health Research Institute, and a director of
Prana.



The Phase IIa study is a randomised, double blind, placebo-controlled
design, in which 80 Alzheimer's disease patients will receive three months
of either one of two oral dose levels of PBT2, or placebo. In addition to
examining safety and tolerability, the study will investigate the ability
of PBT2 to affect multiple cerebrospinal fluid (CSF) and blood biomarkers
of Alzheimer's disease during the treatment period. Outcomes will include
measures of CSF A-beta and tau levels, as well as neurocognitive and
behavioural changes.



This trial forms part of Prana's strategy to assess the behaviour of
PBT2 across a broad dose range, in a manner that is also consistent with
the new European Medicines Agency (EMEA) regulations that permit
accelerated conditional marketing approval for treatments of seriously
debilitating diseases such as Alzheimer's disease. These regulations enable
marketing for such agents in parallel with pivotal, final stage clinical
trials. Mr Geoffrey Kempler, Executive Chairman and CEO commented, "If we
qualify under these regulations we could significantly accelerate PBT2's
pathway to market in Europe.



"We are very pleased with PBT2's development to date. Besides having
successfully completed Phase I, we have also demonstrated, in nonclinical
studies, that PBT2 can prevent the formation of the toxic oligomers of the
A-beta protein, dissolve existing oligomers, and attenuate the production
of free radicals. More recently we have announced that, in transgenic
animal models, (i) PBT2 can improve memory performance within 5 days of
oral dosing, (ii) PBT2 rapidly reduces the levels of soluble A-beta in the
brain, and (iii) PBT2 restores normal function of a-beta impaired synapses.
This gives us great confidence in our commitment to the strategic
development plan for PBT2 as a treatment for the underlying causes of
Alzheimer's disease," concluded Mr. Kempler.
















About Prana Biotechnology Limited



Prana Biotechnology was established to commercialise research into
Alzheimer's disease and other major age-related degenerative disorders. The
company was incorporated in 1997 and listed on the Australian Stock
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 and Massachusetts General
Hospital, a teaching hospital of Harvard Medical School, discovered Prana's
technology.



For further information, please visit our web site at
pranabio.



This press release may contain "forward looking statements" within the
meaning of the Private Securities Litigation Reform Act of 1995 regarding
the Company's business strategy and future plans of operation.


Forward-looking statements involve known and unknown risks and
uncertainties; both general and specific to the matters discussed in this
press release. These and other important factors, including those mentioned
in various Securities and Exchange Commission filings made by the Company,
may cause the Company's actual results and performance to differ materially
from the future results and performance expressed in or implied by such
forward-looking statements. The forward-looking statements contained in
this press release speak only as of the date hereof and the Company
expressly disclaims any obligation to provide public updates, revisions or
amendments to any forward-looking statements made herein to reflect changes
in the Company's expectations or future events.


Prana Biotechnology Limited

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