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TheraGenetics to Develop Dx for Alzheimer’s Rx; Running PGx Study With King’s College

TheraGenetics last week joined the AddNeuroMed Consortium and penned an agreement with King's College London to conduct a pharmacogenomics study to determine which Alzheimer’s patients will respond to cholinesterase inhibitors.
Out of this PGx study, “the company intends to develop and commercialize a diagnostic for treatment response,” a spokesperson for the London-based firm told Pharmacogenomics Reporter this week.
AddNeuroMed is a three-year European Union partnership, launched in 2005, between the pharmaceutical industry and small and medium-sized firms with the goal of improving experimental models of biomarker discovery and, ultimately, finding new biomarkers for Alzheimer’s disease.
AddNeuroMed is part of the EU’s Innovative Medicines Initiative, or InnoMed, which brings together 16 biopharmaceutical companies, 14 universities, and eight SMEs to work on two separate scientific projects: PredTox and AddNeuroMed. The InnoMed initiative has a total budget of €18 million, of which the European Commission is contributing €12 million.
“With more than 9 million people living with Alzheimer's disease worldwide, the need for biomarkers is widely recognized. AddNeuroMed brings together a large and effective consortium to lead biomarker discovery in Europe,” Simon Lovestone, a professor at King's College London, said in a statement.
After the clinical samples for the study were recently collected under AddNeuroMed, TheraGenetics was invited to join the consortium to conduct a PGx study designed to study patients taking cholinesterase inhibitors, and to develop a diagnostic test for treatment response.

“The [study] protocol involves the investigation of biomarkers already identified to be associated with treatment response, and also new biomarkers.”

“The [study] protocol involves the investigation of biomarkers already identified to be associated with treatment response, and also new biomarkers,” a TheraGenetics spokesperson told Pharmacogenomics Reporter this week. The program declined to disclose the biomarkers.
Patients in the study take currently available cholinesterase inhibitors, but TheraGenetics would not specify the drugs. In a statement announcing its involvement in the AddNeuroMed study, TheraGenetics noted that cholinesterase inhibitors such as Eisai/Pfizer’s Aricept (donepezel), Novartis’ Exelon (rivastigmine), and Ortho-McNeil Neurologics’ Razadyne (galantamine) are commonly prescribed to treat the cognitive symptoms of early- to mid-stage Alzheimer’s disease.
This class of drugs prevents the breakdown in the brain of acetylcholine, a chemical known to regulate learning and memory functions. Studies have shown that by increasing the amount of acetylcholine, mental decline can be slowed in Alzheimer's patients.
In clinical studies, all cholinesterase inhibitors work equally well, but overall, as many as 50 percent of patients experience no benefit, according to the Mayo Clinic. Additionally, due to the side effects associated with this class of drugs, including diarrhea, nausea, and vomiting, non-compliance is high.
The global market for Alzheimer's drugs is estimated to grow from $4 billion in 2006 to over $5 billion in 2010. A genetic biomarker-based response test for Alzheimer’s therapies could improve compliance and eventually lead to the development of genetically targeted treatments, experts say.
According to the TheraGenetics spokesperson, the company will analyze the available clinical data in the PGx study to identify the response profile of the patients and to categorize the patients according to their treatment response.
“The next step is to identify genetic biomarkers that are associated with treatment outcome, the first stage in the development of response diagnostic tests using genetic information — [from] a mouth swab or a blood test — to characterize patients according to their likely treatment response,” the spokesperson said.

TheraGenetics, spun out of the Institute of Psychiatry at King's College London in 2006, is currently developing and commercializing a portfolio of pharmacogenetic tests designed to improve treatment options for central nervous system disorders, including schizophrenia, depression, bipolar disease, and attention deficit/hyperactivity disorder. Current investors in the company include Swarraton Partners, Tudor Ventures, IP Group PLC, and Kinetique Biomedical Seed Fund.

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