TauRx Therapeutics Achieves Enrollment Target in the First of Its Two Phase III Clinical Trials of LMTX(TM) in Alzheimer’s Disease

July 16, 2014

ABERDEEN, Scotland and SINGAPORE, July 16, 2014 /PRNewswire/ –

TauRx Therapeutics Ltd [http://www.taurx.com ] announced it has achieved its target
enrollment of 833 subjects into one of its two ongoing multi-center Phase III clinical
trials of LMTX(TM) [http://taurx.com/lmtx-for-ad ], a tau aggregation inhibitor, for the
treatment of Alzheimer’s Disease [AD]. This placebo-controlled clinical trial (Protocol
TRx-237-015 [http://taurx.com/015-clinical-study.html ]) has recruited subjects in North
America, Europe, Russia, Australia and Southeast Asia and is aimed at assessing the
efficacy of LMTX(TM) in slowing the progression of Alzheimer’s in people diagnosed with
mild to moderate disease. The study is also evaluating the safety and pharmacokinetic
profile of LMTX(TM), as well as examining the effect on imaging end-points in a subset of
subjects. TauRx’s other Phase III clinical trial (Protocol TRx-237-005
[http://taurx.com/005-clinical-study.html ]) with a target enrollment of 700 subjects
diagnosed with mild Alzheimer’s is already 80% recruited and is expected to complete its
enrollment in the next 2-3 months.

“Achieving our target enrollment in the first of our two Phase III clinical trials for
Alzheimer’s is an important milestone for our company,” said Professor Claude Wischik,
Chairman of TauRx [http://taurx.com/directors.html ]. “It moves us another step closer to
our objective of bringing the first tau-targeted and genuinely disease-modifying treatment
for Alzheimer’s disease to patients.” Professor Wischik added that “Awareness of our
clinical trial has been high in the light of a string of failures of trials targeting
beta-amyloid. Interest from physicians, carers, patients and international Alzheimer’s
groups demonstrates the need for innovative treatments that halt or slow the progression
of Alzheimer’s so that, in the near future, people with Alzheimer’s may be able to live
without fear of an inevitable decline into dementia.”

Prof. Wischik credited the completion of enrollment for the TRx-237-015 study to the
outstanding support of more than 100 global clinical research centers and dedicated
physician investigators, a motivated TauRx project team as well as the contributions of
its partner companies. In particular, he singled out the efforts put into patient
recruitment by Worldwide Clinical Trials [WCT], a global Clinical Research Organisation
[CRO] that is managing the studies on behalf of TauRx, and MediciGroup(R), Inc. [dba
MediciGlobal Ltd] [http://www.mediciglobal.com ] who specialize in innovative approaches
to global patient recruitment and retention.

TauRx and its partner firms are now turning their attention to completing enrollment
for its other two ongoing Phase III clinical trials: TRx-237-005 for patients with mild
Alzheimer’s and TRx-237-007 [http://taurx.com/007-clinical-study.html ] for patients with
behavioral variant frontotemporal dementia (bvFTD). “LMTX has particular interest for
bvFTD because it targets the aggregation of both tau protein and TDP-43 proteins, which
each account for about half the cases. Since the opportunity for patients with Alzheimer’s
to participate in the remaining AD study is closing fast, we are continuing our outreach
initiatives to reach mild AD patients. Although the bvFTD study has somewhat longer to
run, it is important for patients with this condition to connect with the closest research
centers currently enrolling if they wish to be included in this clinical trial,” Prof.
Wischik said.

Dr. Emer MacSweeney, Re:Cognition Health [http://www.re-cognitionhealth.com ], London,
a leading Physician Investigator participating in both TauRx clinical trials for
Alzheimer’s and the bvFTD trial, noted that there are no approved treatments currently for
Alzheimer’s disease that either slow or halt its progression. “Achieving this feat with
LMTX(TM) would truly be a medical milestone,” Dr. MacSweeney said. She added, “While there
are many Alzheimer’s clinical trials ongoing, TauRx is the only company to bring a tau
aggregation inhibitor to late-stage clinical development. Judging by the results of
TauRx’s substantial body of scientific research in this field, we could at last be on the
right path towards altering the underlying pathology that leads to dementia.”

Dr Richard Holub, Neurological Associates of Albany [http://alzheimersalbany.com ],
NY, a U.S.-based Physician Investigator, added: “After treating dementia patients for many
years, I am very encouraged by the successful enrollment of this trial, which is leading
the way to a potential new and exciting avenue of treatment for this devastating disease.
TauRx is paving the way for the first therapy of this class, bringing a fresh approach to
Alzheimer’s research which could lead to the potential treatment of millions of patients
affected worldwide with Alzheimer’s Disease.”

People and families living with mild Alzheimer’s are encouraged to visit the TauRx
website at http://www.taurx.com to see if they meet the medical criteria for either
the TRx-237-005 [mild Alzheimer's] or TRx-237-007 [behavioural variant frontotemporal
dementia-bvFTD] trials.

For more information, please visit: http://www.taurx.com.

SOURCE MediciGlobal

Source: PR Newswire

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