Full Press Release Details
Commenced in Phase IIa PBT2 Trial of Alzheimer's Patients
of Patients Under Way and Proceeding as Expected -
Australia - December 19, 2006 - Prana Biotechnology Limited (NASDAQ: PRAN /
announced that dosing has commenced in its Phase IIa clinical trial of PBT2
patients with early Alzheimer's disease.
PBT2-201-Euro trial is being conducted in seven centers throughout Sweden and
will focus on exploring the safety and tolerability of PBT2, Prana's proprietary
lead compound, and its effects on the mechanism and progression of the disease,
investigating both central and peripheral biomarkers of Alzheimer's disease as
Principal Investigator for the trial is Professor Lars
department of Public Health/Geriatrics at Uppsala University. Professor Lannfelt
and his laboratory have identified two important human mutations of Alzheimer's
disease (the Swedish and Arctic mutations) that affect the level of amyloid
peptide in the brain, a key discovery in the Alzheimer's field.
years, Sweden has been at the forefront of biomarker research and we now
understand that measurement of central biomarkers provides an important
understanding of the progression of Alzheimer's disease. Our expertise in the
collection, analysis and understanding of biomarkers has meant that many leading
Alzheimer's disease drug development companies, such as Prana, locate their
important clinical biomarker studies here. If this drug can be shown to move
of these biomarkers, it will demonstrate the drug's potential as a mechanistic
treatment for Alzheimer's disease," said Professor Lannfelt.
PBT2-201-Euro trial is a randomized, double blind, placebo-controlled Phase
study, in which 80 Alzheimer's disease patients - male and female subjects
years or older - will randomly receive three (3) months treatment with one
two oral dose levels of PBT2, or placebo. 20 patients will receive a 50mg dose;
30 patients will receive a 250mg dose; and 30 patients will receive the placebo.
The primary endpoint of the study will be the safety and tolerability of PBT2.
The efficacy endpoints will be PBT2's effect on cerebrospinal fluid (CSF) and
plasma biomarkers as well as cognition. Results are expected to be announced
the fourth quarter of 2007.
Prana Biotechnology Limited
Biotechnology was established to commercialize research into Alzheimer's disease
and other major age-related neurodegenerative 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 (Melbourne) and Massachusetts General Hospital, a teaching hospital
Harvard Medical School, discovered Prana's technology.
further information, please visit our web site at www.pranabio.com.
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,
not limited to, PBT2, that could slow or prevent products coming to market,
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
From 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.
| Contacts: | |
| Investor Relations | Media Relations |
| Kathy Price | Ivette Almeida |
| T: 646-284-9430 | T: 646-284-9455 |
| E: kprice@hfgcg.com | E: ialmeida@hfgcg.com |
to the requirements of the Securities Exchange Act of 1934, the registrant
duly caused this report to be signed on its behalf by the undersigned, thereunto
BIOTECHNOLOGY LIMITED