Company Website:
http://www.pranabio.com
MELBOURNE, Australia -- (Business Wire)
Prana Biotechnology(ASX:PBT) (NASDAQ:PRAN) has today announced
the safety outcomes of the IMAGINE Extension study in patients with
Alzheimer’s disease.
A 250mg dose of PBT2 was safe and well tolerated over a 2 year period.
The independent Data Safety Monitoring Board did not identify any safety
concerns related to PBT2.
The IMAGINE Extension Study allowed all 40 participants who completed
the original 12 month IMAGINE trial to receive PBT2 for a further 12
months. In all, 33 out of the 40 eligible IMAGINE patients elected to
continue onto the Extension study. It was an Open Label study, with all
participants taking PBT2. A total of 27 patients completed the Extension
Study.
Clinical and scientific experts are reviewing the effects of PBT2 taken
for 2 years. Whilst there is no placebo group to compare to within the
Extension Study, the experts are very interested in better understanding
how treatment with PBT2 would differ from the anticipated outcome
without treatment.
The safety data will form part of the package presented to the FDA as
part of our goal to remove the Partial Clinical Hold on PBT2 in the US.
Prana will continue to work with the US Food and Drug Administration and
other agencies to initiate a Phase 3 trial for PBT2 to treat Huntington
disease. PBT2 for the treatment of Huntington disease was recently
granted Orphan designation in Europe and was granted Orphan designation
in the US in 2014.
About Prana Biotechnology Limited
Prana Biotechnology was established to commercialise 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 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
This 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 otherrisks 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.
View source version on businesswire.com: http://www.businesswire.com/news/home/20150630006651/en/
Contacts:
for Prana Biotechnology
Investor Relations
Rebecca
Wilson, +61 3 9866 4722
rwilson@buchanwe.com.au
or
Media
Gavin
Lower, +61 3 9866 4722
glower@buchanwe.com.au
Source: Prana Biotechnology
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