TheraGenetics (London/Cambridge, Massachusetts), a personalized medicine company, is developing genetic-based tests to help improve the treatment of central nervous system disorders including depression and schizophrenia and is now part of a consortium to identify biomarkers for Alzheimer's disease.

When the company was launched in April 2006, the plan was to have it follow two tracks: to provide pharmacogenetic tests for antipsychotic medicines already on the market as well as those in development, CEO Richard Kivel told Medical Device Daily's sister publication, BioWorld Today.

The company's tests are being used in research with the hope of selling them to physicians in the future.

TheraGenetics was created as a spin-out of the Institute of Psychiatry at King's College London. The privately held company uses a collection of high-quality genetic samples and clinical data from patients to come up with a rating scale for determining drug responders. Its response-prediction tests that are furthest along involve two of the most prescribed drugs in the area of schizophrenia – olanzapine sold as Zyprexa by Eli Lilly & Co. (Indianapolis), and risperidone (Risperdal) by Johnson & Johnson (New Brunswick, New Jersey).

Kivel believes his company also can benefit smaller firms that have little expertise in the area of pharmacogenetics. The company's founding team has worked for more than 15 years in the field of schizophrenia and related pharmacogenetics.

In September, the company named Robert McBurney as executive vice president, responsible for leading global business development and partnership strategy. He formerly was senior vice president of research & development and chief scientific officer at BG Medicine and is a former president of CeNeS Pharmaceuticals.

TheraGenetics has identified a patent that could determine which patients are susceptible to certain side effects of antidepressants. In July, TheraGenetics completed an agreement with the Centre for Addiction and Mental Health (CAMH) in Toronto, to license intellectual property related to methods and kits for determining a patient's susceptibility to certain side-effects of anti-depressants.

"To date, it has not been possible to predict who will benefit from a treatment and who will suffer side effects," James Kennedy, senior scientist at CAMH, said at the time. "We believe this work and the approach TheraGenetics is taking has the potential to transform the treatment of a number of CNS disorders," added Kennedy, who also is a professor of psychiatry at the University of Toronto, and one of the inventors of the work licensed by TheraGenetics.

CAMH is one of the world's leading research centers in the area of addiction and mental health.

According to TheraGenetics, the company studies large patient groups from around the world treated with different medications to identify multiple variants in genes that effect treatment response and side effects. The company uses this information to design pharmacogenetic diagnostic tests to identify those patients who are most likely to respond to a specific drug and experience the minimum number of side effects.

In addition to depression and schizophrenia, the company's other areas of focus include bipolar disorder, attention deficit-hyperactivity disorder and Alzheimer's disease.

TheraGenetics is part of the AddNeuroMed Consortium to identify biomarkers for Alzheimer's disease that could be used to determine patient response to medications. TheraGenetics will undertake a pharmacogenetic study of Alzheimer's patients treated with cholinesterase inhibitors in the study.

AddNeuroMed is part of InnoMed, a study funded by the European Union in partnership with the pharmaceutical industry and other firms in Europe. The first-of-its-kind collaboration is seeking to generate refined and new pre-clinical models and a large clinical cohort for biomarker studies, according to TheraGenetics.

Cholinesterase inhibitors are a class of drugs approved to treat the cognitive symptoms of Alzheimer's disease. But as many as half the people who take these drugs show no improvement, the company said, citing the Mayo Clinic (Rochester, Minnesota). Others may stop taking these drugs because of the side effects, which include diarrhea, nausea and vomiting.

The most commonly prescribed cholinesterase inhibitors in the U.S. include Aricept (donepezel), Exelon (rivastigmine) and Reminyl (galantamine). The global market for Alzheimer's drugs is projected to grow from $4 billion in 2006 to more than $5 billion estimated in 2010, according to Thomson-Pharma, TheraGenetics said.

Kivel said that the invitation to join the consortium to identify biomarkers for Alzheimer's disease was "incredibly important to us" and would provide an "opportunity for us to really expand our expertise in the field."

Its current investors include Swarraton Partners Ltd., Tudor Capital UK, IP Group plc and Kinetique Biomedical Seed Fund.