Prana Announces Safety Outcomes of Alzheimer’s IMAGINE Extension Trial
01 Juillet 2015 - 5:58AM
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 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.
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version on businesswire.com: http://www.businesswire.com/news/home/20150630006651/en/
for Prana BiotechnologyInvestor RelationsRebecca Wilson,
+61 3 9866 4722rwilson@buchanwe.com.auorMediaGavin Lower,
+61 3 9866 4722glower@buchanwe.com.au
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