For FULL-SCREEN-VIEW, place mouse in the lower right corner of video and click the icon.
In-Depth Article:
Patient enrolment has begun for a human clinical trial to broaden the demonstrated safety range and pharmacokinetic profile of the neuroprotective drug davunetide.
Davunetide is a product of Allon Therapeutics Inc. This trial touches on its potential as a treatment for:
PSP (Progressive Supranuclear Palsy, a form of FTD)
Some FTD (Frontotemporal Dementia)
aMCI (amnestic Mild Cognitive Impairment)
Alzheimer's Disease
Gordon McCauley, president and CEO of Allon, said, "Our research has shown that davunetide reduced tau impairment and preserved memory in mice bred to replicate Alzheimer's or PSP tau pathology. In addition, our Phase II clinical trials have shown that davunetide can also improve memory function in aMCI patients."
PSP is one of a group of progressive disorders called frontotemporal dementia (FTD), that affect the frontal and temporal lobes of the brain, and for which there are no approved treatments. Approximately 200,000 persons in the United States and Canada have been diagnosed with a form of FTD, including 20,000 diagnosed with PSP.
Approximately half of FTDs, including PSP, are tauopathies, which are pathologies that involve impairment of the tau protein in brain cells. McCauley said the Company expects that efficacy in PSP will define the opportunity to use davunetide in other FTD subtypes that are tauopathies.
"We have shown that davunetide is the most advanced tau therapy in the world," stated Gordon McCauley of Allon Therapeutics. Alzheimer's, PSP and other frontotemporal dementias all involve impairment of the brain protein called tau.
About Davunetide
Davunetide is derived from a naturally occurring neuroprotective brain protein known as activity dependent neuroprotective protein (ADNP). Allon's laboratory and animal studies have shown that davunetide restores the function of structures in the brain - known as microtubules - which are critical to communication between brain cells and the structure of individual cells.
In 2008, Allon reported Phase IIa clinical trial results showing that davunetide had a statistically significant positive impact on memory function in patients with amnestic mild cognitive impairment (aMCI), a precursor to Alzheimer's disease (AD). The data was presented July 28 and July 30, 2008 to the International Conference on Alzheimer's Disease and Related Disorders (ICAD 2008).
The Trial
The trial is a randomized, double-blind, placebo-controlled study to compare multi-dose safety, tolerability and pharmacokinetic profile of davunetide in a minimum of 10 healthy adult subjects aged 45 to 65 years.
This pilot trial is intended to treat a small number of patients with tau impairments, including PSP. This trial will help validate the trial design and prepare for a larger Phase II clinical trial that the Company intends to initiate later in 2010. Trial investigators are among the leading experts in the field, including Drs. Bruce Miller and Adam Boxer of the Memory and Aging Center of the University of California, San Francisco.
Trial Basis
Dr. Donald E. Schmechel, the principal investigator of the previous trial upon which the upcoming one is based, said that past results are compelling and potentially important for the treatment of dementias such as Alzheimer’s and for the millions of dementia patients and their families.
“Short-term memory, recognition, and working memory deteriorate rapidly in the early stages of Alzheimer’s disease,” said Dr. Schmechel.
“Improving these memory functions with 12-weeks of treatment is certainly relevant to clinical practice in Alzheimer’s disease.”
“Successfully impacting these specific memory domains indicates AL-108 (davunetide) is active in the regions of the brain responsible for their function — primarily the medial temporal lobe, hippocampus and prefrontal cortex, said Dr. Schmechel.
“The combination of the symptomatic impact shown in this clinical trial and Allon’s pre-clinical data showing an impact on plaques and tangles, the classic hallmarks of Alzheimer’s disease, highlights the potential of AL-108 as a disease-modifying therapy,” Schmechel added.
Dr. Schmechel is an adjunct Professor of Medicine (Geriatics), at Duke University Medical Center in Durham, North Carolina, and the Medical Director of The Falls Neurological and Memory Center at the Caldwell Memorial Hospital.
Northwestern University researchers found that brains of people in their 80's with extra-sharp memories had far fewer fiber-like "tau" tangles than average.
Scientists working on curesfor Alzheimer’s disease find it hard to develop drugs that will pass through the highly selective blood-brain barrier. A Tel Aviv University researcher decided to take an alternate route to the brain - through the nose.
An overview of research in many promising new treatments for Alzheimer's and frontotemporal dementia. The work, at the UCSF Memory and Aging Center, touches on breakthroughs and reality-checks. This is a great 10-minute snapshot of the state-of-the-art in dementia research.
Scientists working on curesfor Alzheimer’s disease find it hard to develop drugs that will pass through the highly selective blood-brain barrier. A Tel Aviv University researcher decided to take an alternate route to the brain - through the nose.
