Oct 30, 2012

Remember Rember, TauRx Therapeutics Ltd Announces Clinical Trials

A major breakthrough in the treatment of Alzheimer's disease was revealed by scientists at the Alzheimer's Association International Conference on Alzheimer's Disease in 2008 (ICAD 2008).

Alzheimer's Reading Room

Remember Rember, TauRx Therapeutics Ltd  Announces Clinical Trials
At least that is what we thought in 2008. Every major news outlet from CNN on down interviewed the scientist live about this remarkable scientific news. It was a news feeding frenzy.

The tiny, little, Alzheimer's Reading Room was bombarded by visitors looking for information on the this new wonder drug called - Rember. The Alzheimer's Community was thirsty for news. After all, TauRx were selected by the Alzheimer's Association to present their Phase 2 clinical trial findings.

And then the silence. Nothing. Well mostly hype until yesterday in Monte Carlo at CTAD - the 5th edition of Clinical Trials on Alzheimer’s Disease (CtaD) 2012.

Yesterday, TauRx Therapeutics Ltd announced the initiation of two global Phase 3 clinical trials in mild to moderate Alzheimer’s disease.

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A quick check at ClinicalTrials.gov does show two clinical trials as scheduled to open but they are not yet recruiting patients. No clinical trial locations are listed for either trial.

You can find an an email listed for contact on the pages describing the inclusion/exclusion criteria, etc., for the Phase 3 clinical trials.

Here are the two listings on ClinicalTrials.gov.

Safety and Efficacy Study Evaluating TRx0237 in Subjects With Mild to Moderate Alzheimer's Disease. ClinicalTrials.gov Identifier: NCT01689246. Enrollment 833 patients.

Safety and Efficacy Study Evaluating TRx0237 in Subjects With Mild Alzheimer's Disease. ClinicalTrials.gov Identifier: NCT01689233. Enrollment 500 patients.

You can find all the available clinical trial information by following the two links above. You can also read about - Rember - by searching the ARR knowledge base.

Here is the Company press release.

Announcing a new era in Alzheimer’s

The time for Tau is now as Phase 3 clinical trials get under way with a second-generation Tau Aggregation Inhibitor (TAI) aimed at halting the progression of Alzheimer’s

TauRx Therapeutics Ltd announced today the initiation of two global Phase 3 clinical trials in mild to moderate Alzheimer’s disease.

These landmark studies could provide the first definitive data on a Tau-based approach to disease-modifying and preventative treatment of Alzheimer’s for at least the next 5–7 years, said Professor Claude Wischik, Chairman of TauRx and Professor of Old Age Psychiatry at the University of Aberdeen, in a press conference at the 5th Clinical Trials Conference on Alzheimer’s Disease (CTAD) in Monte Carlo,
Monaco today.

The studies culminate three decades of research by Professor Wischik and colleagues, including the original discovery of the Tau protein as the main constituentof the Tangle pathology of Alzheimer’s disease [‘Tau tangles’], the development of the first Tau Aggregation Inhibitor (TAI), and results from an earlier Phase 2 clinical trial involving more than 300 patients that showed a 90% reduction in the rate of
disease progression over two years.

“These Phase 3 studies are bringing us closer to finding an effective treatment that can actually arrest the progression of the disease,” said Professor Wischik. “We are building on over thirty years of research, and the encouraging results from our previous Phase 2 clinical trial in Alzheimer’s disease support an approach which targets the abnormal Tau aggregates in the brain.”

The studies, which have already starting enrolling in the U.S., aim to confirm the disease-modifying effects seen in the Phase 2 studies in mild to moderate patients over an 18-month timeframe. The first study will involve 833 people with mild to moderate Alzheimer’s disease over 12 months.

The second study will include 500 people with mild Alzheimer’s disease over 18 months.

The study drug, ™, is a second-generation TAI that targets the Tau tangles and their precursors, dissolving them in order to halt their harmful effects on memory.

LMTX™ also works on the early stage Tau aggregates (called ‘oligomers’) which are precursors to fully-formed tangles and are thought to be particularly toxic.

“Clinicians devoted to Alzheimer’s disease have been waiting for a promising agent with disease-modifying properties,” said Professor Serge Gauthier of the McGill  Centre for Studies in Aging, Quebec, Canada. “The basic science data for this agent, particularly in the tauopathies, looks sound and the interest among investigators and  among families is high.” Professor Gauthier is a clinical investigator and scientific
advisor for TauRx.

In a recent PharmaVoice article, William Thies, PhD, Chief Medical and Scientific Officer of the Alzheimer’s Association, commented that researching Tau as a therapeutic agent in Alzheimer’s is a solid path to follow, since Tau tangles are one of the hallmark lesions identified in the disease.

The tangles in the brain were first reported by Dr. Alois Alzheimer in 1907, starting the century-long journey to  understand the pathology leading to their formation, their role in dementia, and,
ultimately, how to stop their spread through the brain.

Professor Lon Schneider, MD, of the Keck School of Medicine at the University of Southern California, a scientific advisor for TauRx, said: “Successfully targeting Tau may be an important approach towards slowing and ideally halting the neurodegeneration that is characteristic of Alzheimer’s disease or frontotemporal  dementia. Clinicians need these Phase 3 studies to produce clear evidence that such
an approach could lead to improved patient outcomes.”

Countries in which the Phase 3 clinical trials will be conducted include Australia, Belgium, Canada, Finland, France, Germany, Italy, Russia, Spain, Netherlands, Singapore, Malaysia, Taiwan, U.S., and U.K.  Patients and caregivers are invited to  sign up for study updates at www.AlzheimersStudies.com, as the clinical trials are  initiated in the countries selected.

About Alzheimer’s Disease and Tau Tangles:
Alzheimer’s disease is one of the most important health challenges worldwide, and the most-common type of dementia. According to the Geneva-based World Health  Organization, global dementia cases are expected to double within 20 years to an  estimated 65.7 million people [more than the entire population of France currently at  63 million people].

In very early, asymptomatic Alzheimer’s, pre-tangle Tau  aggregates (oligomers) and Tau protein tangles are already present in the same  regions of the brain where neuronal degeneration and loss of neuronal cells
eventually occur.

These changes first appear 20 – 30 years before the disease  becomes clinically evident. With time, Tau tangles spread from the entorhinal cortex (responsible for learning, memory, thinking and planning) through the hippocampus to the neocortex (affecting the ability to communicate, recognize family and loved  ones and to care for oneself), resulting in neuronal dysfunction and worsening of clinical symptoms.

The spread is now thought to be due to a prion-like process whereby the oligomers act as ‘infectious particles’ which are able to propagate the  abnormal aggregation of Tau protein from one neurone to the next.

These oligomers recruit normal Tau to produce yet more infectious oligomers which spread
neuronal destruction throughout the brain.

About TauRx Therapeutics:
TauRx Therapeutics Ltd was established in Singapore in 2002 with the aim of  developing new treatments and diagnostics for a range of neurodegenerative diseases based on an entirely new approach which targets aggregates of abnormal  fibres of Tau protein that form inside nerve cells in the brain, giving rise to Tangles.

The TauRx team have since discovered that LMTX™ could also have beneficial effects in several other neurodegenerative diseases associated with Tau pathology, as well as other protein aggregation disorders including Parkinson’s, Huntington’s,Frontotemporal Dementia [FTD-Pick’s Disease], Progressive Supranuclear Palsy and Cortico-Basal Degeneration. While TauRx corporate headquarters are in Singapore,
its primary research facilities are in Aberdeen, Scotland.

Original content Bob DeMarco, the Alzheimer's Reading Room