Friday, July 11, 2008

TheraGenetics teams up on safer CNS drug use

By Ryan McBride

Diagnostics startup TheraGenetics Ltd. has signed a licensing deal with a renowned Canadian mental health center to expand its portfolio of genetic indicators, which the firm plans to use to develop tests that predict how patients would respond to treatments for central nervous system (CNS) disorders based on their genes.

Because patients respond well to CNS drugs only about half of the time, TheraGenetics CEO Richard Kivel said, he hopes the firm’s pharmacogenetic tests will match people with effective treatments and help their physicians know which medications are likely to cause harmful side effects. He said the U.S. market for such tests, which are increasing in number due to advances in the field of genetics, is in the billions of dollars.

TheraGenetics, which is based in London and has U.S. offices in Cambridge, Mass., licensed from the Centre for Addiction and Mental Health in Toronto patented genetic markers linked to side effects of a popular class of anti-depressant drugs known as selective serotonin reuptake inhibitors (SSRI). Kivel declined to name specific SSRIs for which his firm would develop pharmacogenetic tests, but some well-known drugs in the class include Prozac and Zoloft.

“This was a very important patent (license) for us, to demonstrate that we have an issued U.S. patent for the depression space,” Kivel said.

The genetic indicators licensed from the Canadian mental health center were found in bipolar patients who experienced mania after taking anti-depressants, Kivel said. Mania happens when patients experience wide mood swings that can lead to high-risk behaviors such as excessive gambling or violent outbursts.

According to James Kennedy, a psychiatrist from the Centre for Addiction and Mental Health, there is as yet no way to predict who will benefit from a given anti-depressant and who will suffer side effects. 

TheraGenetics plans to develop a test that would show physicians whether patients have the genes related to the mania side effect before they prescribe an anti-depressant. Kivel said it would take about a year and a half to conduct studies of the test and to gain U.S. Food and Drug Administration clearance to begin sales.  

TheraGenetics is also developing a test to predict patient responses and the potential for side effects from drugs used to treat such CNS diseases as schizophrenia and bipolar disorder, with technology licensed from the Institute of Psychiatry at King’s College London. The firm was founded in 2006 by researchers at King’s College and maintains labs there. Kivel, the former CEO of defunct Cambridge bioinformatics startup MolecularWare Inc., joined the company in 2006. 

The company isn’t the only local developer of pharmacogenetic tests for CNS disorders. Clinical Data Inc. (Nasdaq: CLDA), a Newton biotech firm, is developing such a test in concert with an anti-depressant called vilazodone. Yet Kivel said he has spoken with Clinical Data executives and doesn’t consider the company a competitor.