prana - for gerry stolwyk gerry - do u like PBT at these...

prana - for gerry stolwyk gerry - do u like PBT at these levels??
I do !

PRANA BIOTECHNOLOGY RECEIVES CLINICAL TRIALS
AUTHORISATION IN UK TO INITIATE PLACQUE PHASE II/III STUDY
- Enrolment of 435 Alzheimer’s Patients to Begin in Q2 2005 -
Melbourne, Australia – January 4, 2005: Prana Biotechnology Limited (NASDAQ:
PRAN, ASX: PBT), today announced it has received a Clinical Trials Authorisation
(CTA) from the Medicines and Healthcare Products Regulatory Agency (MHRA) of the
United Kingdom to initiate the potentially pivotal PLACQUE (Progression Limitation in
Alzheimer’s: ClioQUinol’s Efficacy) Phase II/III clinical trial.
· CTA approval enables company to move forward
· Study enables Prana to progress to late stage development company
· Prana meets milestone outlined at Analyst Briefing
· PBT-1 may be first drug to modify the progression of Alzheimer’s disease
Study Specifics
The PLACQUE trial will be conducted over 52 weeks and will enrol 435 patients in the
United Kingdom, Australia and the Republic of South Africa. The purpose of the study is
to assess the efficacy of two dose levels of PBT-1 (clioquinol) when added to the current
therapy of patients with moderate Alzheimer’s disease. The trial will be randomised,
double blind and placebo-controlled. The primary endpoint of the study will be to
demonstrate a reduction in the progression of Alzheimer’s as measured by the
Alzheimer’s Disease Assessment Scale-cognition (ADAS-cog).
Significant Milestone
“Receiving CTA approval is a significant milestone for Prana,” said Jon Alsenas, CEO of
Prana. “When 2004 began, the future of PBT-1 was uncertain due in large part to patent
litigation and other concerns. Now as we begin 2005, the patent litigation with P.N.
Gerolymatos, S.A. is behind us and we are on the cusp of transforming Prana from an
early stage development company to a late stage development company with the
initiation of the potentially pivotal PLACQUE trial. The CTA approval allows us to clear
the first regulatory hurdle to establishing PBT-1 as the first truly effective therapy for
Alzheimer’s sufferers.
“We are extremely hopeful that PBT-1 will be the first drug to target what is believed to
be the root cause of Alzheimer’s disease – the accumulation of amyloid plaques in the
neocortex of the brain,” continued Dr. Alsenas. “Clioquinol appears to be one of the lead
candidates to have a significant impact on both clinical symptoms and disease
progression.”
Outlook for 2005
Prana expects to have two promising Alzheimer’s drugs in the clinic, with the PBT-1
Phase II/III PLACQUE study initiating in the second quarter and the PBT-2 Phase I
clinical trial also commencing in early 2005. Moreover, Prana continues to focus upon
developing a pipeline of drugs for the treatment of other disorders where inappropriate
protein aggregation plays a key role, such as in Parkinson’s disease.
“The Metal Theory”
The prize-winning science behind PBT-1 is based upon what is known as “the metal
theory” of Alzheimer’s disease. The theory is based on the premise that key metals,
such as zinc and copper, are required for the inappropriate aggregation of amyloid beta
to form the amyloid plaques. These plaques are then thought to cause the
neurodegeneration associated with Alzheimer’s disease. PBT-1 is the first of Prana’s
Metal-Protein Attenuating Compounds (MPACs) to be studied in a potentially pivotal
trial. The metal-mediated aggregation of proteins is also thought to be a key contributor
to the development of a variety of other degenerative disorders.
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 and Massachusetts General Hospital, a
teaching hospital of Harvard Medical School, discovered Prana’s technology.
For further information, please visit our web site at www.pranabio.com.
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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.
Contacts:
US Australia
Kathy Price, Investor Relations
T: 212 983 1702 ext. 212
Rebecca Piercy, Media Relations
T: 61 3 9866 4722
[email protected]
Ivette Almeida, Media Relations
T: 212 983 1702 ext. 209
Geoffrey Kempler, Executive Chairman
T: 61 3 9349 4906