The Lancet Neurology Publishes Prana's Huntington Disease Trial
November 19 2014 - 10:00AM
Business Wire
Prana Biotechnology (ASX:PBT)(NASDAQ:PRAN) has today announced
the results of its Phase 2 trial in Huntington Disease, REACH2HD,
has been published online in one of the world’s leading medical
journals, The Lancet Neurology.
Prana announced in February 2014 the Company had successfully
met its primary endpoint of safety and tolerability in the REACH2HD
study, a double-blind, placebo-controlled study conducted by Prana
and the Huntington Study Group at research sites in the United
States and Australia. The study enrolled 109 individuals with
Huntington disease who were randomly assigned to receive daily
doses of either PBT2 250mg, PBT2 100mg, or placebo for 26
weeks.
The paper was authored by investigators from the Huntington
Study Group led by Dr Ray Dorsey, Professor of Neurology at the
University of Rochester and the Principal Investigator on the
trial. The paper is accompanied by an editorial in The Lancet
Neurology. The results support the view the findings of the
REACH2HD Study warrant further investigation in a large clinical
study powered to measure efficacy.
Dr Dorsey said: “Publication in The Lancet Neurology reflects
the outstanding contribution of the investigators and participants
in the study, highlights the importance of the study, and serves as
a basis for planning future studies of PBT2 for the treatment of
Huntington disease.”
Geoffrey Kempler, Executive Chairman of Prana Biotechnology,
said the next steps for the commercialisation program of PBT2 for
Huntington disease was the End of Phase 2 meeting with the US Food
and Drug Administration (FDA). Prana is currently finalising the
dossier to submit to the FDA for this meeting.
“The Lancet publication supports our commitment to take the next
steps in the commercial pathway towards developing PBT2 as a
treatment for Huntington disease,” Mr Kempler said.
“Publication of the Reach2HD trial follows the recent granting
of Orphan Drug designation by the FDA for PBT2 for Huntington
Disease.”
The Lancet Neurology paper is available at
http://www.thelancet.com/journals/laneur/onlinefirst
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.
Investor RelationsBuchan ConsultingRebecca Wilson, +61 3
9866 4722rwilson@buchanwe.com.auorMediaBuchan ConsultingBen
Oliver, +61 3 8866 1205boliver@buchanwe.com.au
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