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Takeda and Zinfandel Pharmaceuticals Initiate Phase 3 TOMMORROW Trial of AD-4833 for the Delay of Onset of Mild Cognitive Impairment Due to Alzheimer’s Disease in Subjects Selected Using a Genetic-Based Biomarker Risk Assignment Algorithm

Takeda Pharmaceutical Company Limited (“Takeda”) and its partner, Zinfandel Pharmaceuticals, Inc. (“Zinfandel”), recently announced the initiation of TOMMORROW, a global Phase 3 clinical trial investigating a genetic-based biomarker risk assignment algorithm (risk assignment algorithm) to predict risk of mild cognitive impairment (MCI) due to Alzheimer’s disease (AD) within a five year period and to evaluate the efficacy of the investigational low dose pioglitazone (designated AD-4833 for this use) in delaying the onset of MCI due to AD in cognitively normal individuals at high risk as determined by the risk assignment algorithm.

The risk assignment algorithm is comprised of apolipoprotein E (APOE) and TOMM40 genotypes and age. Age and APOE genotype have previously been shown to indicate elevated risk of AD. The addition of TOMM40 is hypothesized to further refine the risk determination.

“To date, there have been a number of avenues investigated with the goal of altering the course of Alzheimer’s disease but results have been unsuccessful,” said Allen Roses, M.D., Chief Executive Officer, Zinfandel. “This is why the TOMMORROW trial is important. The potential to identify an individual’s risk for developing MCI due to AD warrants further investigation.”

AD is a devastating disease and diagnoses are increasing as the world’s population ages. Currently 35.6 million people worldwide are living with some form of dementia. Studies show that individuals with MCI are at an increased risk of developing AD or another dementia with conversion rates of approximately 15 percent per year.

“AD-4833 is a member of a class of drugs known as PPAR (peroxisome proliferator-activated receptor)-gamma agonists which available data show may have a beneficial role in delaying symptoms of MCI due to AD,” noted Stephen Brannan, M.D., Central Nervous System Development Therapeutic Area Head, Takeda. “TOMMORROW is a significant study and represents a novel clinical milestone and trial for the Alzheimer’s community as it evaluates pre-symptomatic patients.”

Source: Taleda Pharmaceutical Company Limited

Quest Diagnostics Launches New Molecular Test Panel for Enhanced Thyroid Cancer Detection

Quest Diagnostics (NYSE: DGX), the world’s leading provider of diagnostic testing, information and services, today announced a new molecular test panel designed to help physicians determine if a thyroid gland is cancerous and requires surgical removal. The test is believed to be the most comprehensive panel clinically available to identify mutations associated with four gene markers indicated by the American Thyroid Association for the clinical management of indeterminate thyroid biopsies.

Metabolon Awarded US Patent for Metabolic Biomarkers of Efficacy of Peroxisome Proliferator Activated Receptor (PPAR) Affecting Drugs

Metabolon, Inc., leaders in global metabolomics, biomarker discovery and biochemical analysis, announced today the grant of US Patent 7,807,138 entitled “Biomarkers of Metabolic Responses to Hepatic Drugs”. The USPTO awarded the patent to Metabolon on October 5, 2010. This is the 13th patent issued to Metabolon and the second in its portfolio of biomarker patents.