Phase 3 Clinical Trial Begins in Early Form of Dementia
MANCHESTER, England, September 10, 2012 /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®, 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® 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® was found to arrest the progression of the disease. LMTX® 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.