Phase 3 Clinical Trial Begins in Early Form of Dementia

Manchester, England (ots/PRNewswire) -

Investigational drug study follows earlier study with
promising results in

mild to moderate Alzheimer's patients

TauRx Therapeutics today announced the initiation of a global
Phase 3 clinical trial in a type of Frontotemporal Dementia (FTD)
also known as Pick's Disease. The announcement, which immediately
follows The 8th International Conference on Frontotemporal Dementias,
held 5-7 September in Manchester, England, underscores the need for
new treatments for this form of dementia that is similar to
Alzheimer's Disease, except that it tends to damage different areas
of the brain and affects people as early as 40 years old.

The study focuses on a type of FTD known as behavioural-variant,
or bvFTD, which can cause early changes in personality and loss of
empathy. A large percentage of these patients have a specific
pathology that involves abnormal collections of tau protein in the
brain.

The study drug, LMTX(R), targets a process in the brain whereby a
normal form of tau protein begins to self-aggregate due to binding
neuronal waste-products. Once the process has started, the aggregates
are able to propagate themselves indefinitely, using up normal tau
protein and converting it into the toxic aggregates. After destroying
the nerve cells where they are initially formed, the aggregates go on
to infect nearby healthy neurons, progressively spreading and
accelerating the destruction throughout the brain. LMTX(R) stops this
aggregation process in its tracks and releases the trapped tau
protein in a form which can be easily cleared by nerve cells.

In a pilot series of cases, LMTX(R) was found to arrest the
progression of the disease. LMTX(R) has been found to act in a
similar way on the aggregation of TDP-43 protein. Tau or TDP-43
aggregates each account for about 50% of patients with this early
form of dementia.

Speaking to patients and caregivers at the FTD conference in
Manchester, Professor Bradley Boeve of the Mayo Clinic in the U.S.,
one of the investigators of the study, said: "Clinicians devoted to
FTD clinical trial development have been refining the measures to use
in an experimental trial in FTD spectrum disorders for years, and
frankly have been waiting for a promising agent. The basic science
data for this agent, particularly in the tauopathies, looks sound and
the excitement among investigators and among families is high."

The Phase 3 double-blind placebo-controlled study is designed to
evaluate the safety and efficacy of LMTX(R), the second-generation
Tau Aggregation Inhibitor (TAI) developed by TauRx. The study aims to
confirm the results first seen in the pilot cases in a larger
controlled clinical trial in bvFTD patients over a 52-week timeframe.
Participating study sites are located in Canada, U.S., U.K., Germany,
The Netherlands, Australia and Singapore. Because the condition is
relatively rare, TauRx was granted Orphan Designation for LMTX(R) in
2010, which provides a basis for more rapid approval for marketing if
the trial is successful.

"This is an important step forward in our quest to find an
effective treatment, with a goal to actually arrest the progression
of the disease," said Professor Claude Wischik, founder and CEO of
TauRx Therapeutics and Professor of Old Age Psychiatry at the
University of Aberdeen. "We are building on over thirty years of
research, and the encouraging results from our previous Phase 2
clinical trial in Alzheimer's Disease, which is also correlated with
abnormal tau aggregates in the brain."

TauRx previously tested rember(c), the first-generation TAI on
which LMTX(R) is based, in a Phase 2 clinical trial involving 321
patients with mild and moderate Alzheimer's Disease in the UK and
Singapore. This study found a 90% reduction in the rate of disease
progression over two years in Alzheimer's Disease. Professor Wischik
and his team have spent nearly 24 years investigating the structure
and role of Tau tangles in the development of Alzheimer's disease,
FTD and other neurodegenerative diseases. They were the original
discoverers of the Tau protein pathology of Alzheimer's.

"It's very exciting news that a treatment is being tested for FTD
in a clinical trial," said Penelope Roques of the Frontotemporal
Dementia Support Group in the UK. "This is encouraging progress in a
disease where there is currently no treatment available." The group
has about 1,000 members across the UK, ranging from FTD patients,
caregivers and family members.

If successful, this will be the first investigational drug that
is able to arrest the progression of this disease. TauRx
Therapeutics, a Singapore-based company spun out of the University of
Aberdeen, developed the novel treatment based on an entirely new
approach which targets aggregates of abnormal fibres of tau protein
that form inside nerve cells in the brain. The TauRx team have since
discovered that LMTX(R) could also have beneficial effects on other
proteins which aggregate abnormally, including TDP-43 in FTD and
synuclein in Parkinson's disease. In FTD, the frontal and temporal
lobes are affected first, which impacts behaviour and emotion. As the
disease progresses, other parts of the brain are affected, eventually
producing a global dementia.

Patients and caregivers are invited to sign up for future updates
as more news is available at http://www.PicksDementiaStudy.info.

About Pick's Disease:

According to the Association for Frontotemporal Degeneration
(AFTD), bvFTD - or Pick's disease as it was originally known - can
cause early and progressive changes in personality, emotional
'blunting' and loss of empathy. A person with the disorder may have
difficulty controlling their behaviour, which can result in socially
inappropriate responses or actions. Language may also be impaired
after behavioural changes take place, as well as neurological
symptoms such as movement and coordination difficulties. Over time,
these symptoms worsen. The bvFTD form of the disease is particularly
aggressive and progresses faster than Alzheimer's disease.

About TauRx:

TauRx Therapeutics was established in Singapore in 2002 with the
aim of developing new treatments and diagnostics for a range of
neurodegenerative diseases based on its technology platform. The
TauRx team includes highly skilled and internationally recognised
pharmaceutical experts in drug discovery and development. The
company's Tau Aggregation Inhibitors (TAIs) include rember(R) and
LMTX(R), the second-generation drug that is being studied in Phase 3
clinical trials in Alzheimer's and FTD. TauRx is headquartered in
Singapore with primary research facilities in Aberdeen, Scotland.

ots Originaltext: TauRx Therapeutics
Im Internet recherchierbar: http://www.presseportal.de

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