ABERDEEN, Scotland and SINGAPORE, July 16, 2014 /CNW/ - TauRx Therapeutics Ltd announced it has achieved its target enrollment of 833 subjects into one of its two ongoing multi-center Phase III clinical trials of LMTX™, a tau aggregation inhibitor, for the treatment of Alzheimer's Disease [AD]. This placebo-controlled clinical trial (Protocol TRx-237-015) has recruited subjects in North America, Europe, Russia, Australia and Southeast Asia and is aimed at assessing the efficacy of LMTX™ 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™, 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) 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. "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 β-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®, Inc. [dba MediciGlobal Ltd] 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 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, 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™ 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, 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.
For further information: (North America) Liz Moench, +1?610?659?5093, [email protected]; Courtney Hollinger, +1?484?674-6825, [email protected]; (International) Elizabeth Puller, +44-208-834-1447, [email protected], Email: [email protected], Website: http://www.taurx.com