Prana's Parkinson's drug meets Michael J. Fox Foundation development milestone
MELBOURNE, Australia - August 30, 2012 - Prana Biotechnology Limited (NASDAQ: PRAN / ASX: PBT), announced today that its lead compound in development for Parkinson's disease (PD), PBT434, had progressed successfully through a series of preclinical development studies used to assess the suitability of a candidate compound for human clinical studies. The studies were funded by The Michael J. Fox Foundation (MJFF) 2011 Pipeline Program to support its 'Therapeutic Development Initiative'. The MJFF Program grant is milestone based. PBT434 achieved all of its milestones in preclinical toxicology studies, genotoxicity and safety pharmacology - allowing the compound to be positioned for larger scale animal toxicology studies prior to commencing clinical trials.
PBT434 is a novel, orally available compound that easily crosses
into the brain and is able to exert potent neuroprotective
properties. Most particularly, it preserves the brain tissue in PD
that degenerates over time, the substantia nigra. By preserving
this tissue, Prana's scientists have demonstrated significant
restoration of motor coordination and strength in animal models.
PBT434 has been shown that it is able to impede the iron-induced
oxidative damage and neurotoxic cascade that kills the substantia
nigra. As such, PBT434's mechanism of action offers a novel disease
modifying therapeutic strategy in contrast to the currently
marketed symptomatic agents that, at best, serve to reduce the side
effects of the disease rather than alter its course.
"Based on these efficacy studies and now the completion of this
suite of preclinical development assessments, Prana will look to
move PBT434 into longer term toxicology studies in parallel to our
scale up manufacturing plans for PBT434. All being well, we could
file an IND by the end of next year and commence clinical trials in
2014" said Mr Geoffrey Kempler, Prana's Executive Chairman. "PBT434
also marks another product pipeline milestone for Prana to
complement our two ongoing trials with PBT2 in Alzheimer's disease
and Huntington disease" commented Mr Kempler.
Parkinson's disease is a devastating illness which can result in
not only the loss of muscle control, speech, balance and digestive
functions; it may also impair a patient's psychiatric and cognitive
function. With 4 million people affected worldwide, Parkinson's
disease is the second most common neurological indication behind
Alzheimer's disease. The current market size for drugs to treat
Parkinson's disease is approximately $4 billion per year; however
most currently available drugs primarily treat the symptoms and do
not actually prevent the ongoing destruction of the substantia
nigra in the brain and progression of the disease.
* The program grant title is 'PBT434, a novel neuroprotective drug
for Parkinson's Disease; completion of pre-clinical studies to
enable human clinical trials'.
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 Securities 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.
About The Michael J. Fox Foundation for Parkinson's Research
As the world's largest private funder of Parkinson's research, The Michael J. Fox Foundation is dedicated to accelerating a cure for Parkinson's disease and improved therapies for those living with the condition today. The Foundation pursues its goals through an aggressively funded, highly targeted research program coupled with active global engagement of scientists, Parkinson's patients, business leaders, clinical trial participants, donors and volunteers. In addition to funding over $250 million in research to date, the Foundation has fundamentally altered the trajectory of progress toward a cure. Operating at the hub of worldwide Parkinson's research, the Foundation forges groundbreaking collaborations with industry leaders, academic scientists and government research funders; increases Parkinson's awareness through high-profile advocacy, events and outreach; and coordinates the grassroots involvement of thousands of Team Fox members around the world.
For more information, visit: www.michaeljfox.org; www.facebook.com/michaeljfoxfoundation.
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.
Contacts:
Prana Biotechnology Limited
+61 3 9349 4906
Investor Relations
Leslie Wolf-Creutzfeldt
T: 646-284-9472
E: leslie.wolf-creutzfeldt@grayling.com
Media Relations
Ivette Almeida
T: 646-284-9455
E: ivette.almeida@grayling.com
Posted: August 2012
