Schizophrenia Daily News Blog

NIMH-Funded Phase II Trials for Schizophrenia Cognitive Impairment Drug Begins

Impairment in cognition (thinking) can be disabling for some people with schizophrenia. The U.S. National Institute of Mental Health (NIMH) is funding research into addressing this persistent problem affecting the quality of life for so many people.

Below is a press release about a drug created by Allon Therapeutics Inc., which, it is hoped, will alleviate some of the cognitive impairment that is common in patients with schizophrenia. The drug, tagged for now as simply AL-108, is entering into NIMH-funded phase II clinical trials.

Allon Therapeutics Inc. today announced that its drug AL-108 will be investigated in a Phase II human clinical trial as a potential treatment for cognitive impairment in schizophrenia. The United States National Institute of Mental Health-funded project, Treatment Units for Research of Neurocognition in Schizophrenia (TURNS) selected Allon's drug AL-108 and will conduct the Phase II clinical trial.

"The TURNS group is comprised of some of the best minds in psychiatric practice and schizophrenia research in the world today. For clinicians of this calibre to select and conduct a Phase II trial with a product from our pipeline is a significant validation of our technology, especially with the wide range of opportunities that TURNS reviews. This collaboration provides Allon a new market opportunity in a chronic indication that is an unmet medical need," said Gordon McCauley, President and CEO of Allon.

Dr. Jeffrey Lieberman, chairman of the Department of Psychiatry at Columbia University, New York, and Director of the TURNS Scientific Operations Unit, said AL-108 has the potential to improve cognition in schizophrenia patients.

"Pre-clinical studies have shown that AL-108 is effective in improving learning and memory in animals and in Phase I human clinical trials it is safe and well-tolerated by healthy adults and patients," said Dr. Lieberman. "These studies clearly indicate that AL-108 has the potential to improve cognition in schizophrenia patients and we are anxious to commence the Phase II trial that will begin this evaluation."

According to Datamonitor, there are estimated to be over 2 million people in North America who suffer from schizophrenia-related cognitive impairment. TURNS was created by the U.S. National Institute of Mental Health, one of the U.S. National Institutes of Health, to identify drugs that improve cognition and that can be combined as co-treatments with anti-psychotic drugs that control the psychotic episodes that characterize schizophrenia. To date, first and second generation anti-psychotic drugs have shown little impact on cognitive impairment suffered by schizophrenia patients.

"Our collaboration with TURNS expands our clinical development of AL-108 into another indication for which there are no effective drugs available to millions of patients around the world," said McCauley. "Allon will provide AL-108 drug product to support the TURNS investigators at their seven clinical trial sites."

The clinical trials sites include some of the most prestigious medical centers in the U.S. including: Harvard Medical School, The University of California at Los Angeles, Maryland Psychiatric Research Center, Washington University Medical Center, Nathan Kline Institute, Columbia University Medical Center and Duke University. The Phase II AL-108 trial will begin in 2007.

Allon's compounds have a unique mechanism of action and have been shown to be effective in treating the underlying causes of more than nine brain diseases and conditions. Drugs on the market today treat only the symptoms - not the causes - of these diseases and injuries.

The Company has two products in human clinical trials. AL-108 is being evaluated in a Phase II trial as a treatment for Alzheimer's and AL-208 is being evaluated in a Phase II trial as a prevention and treatment for the mild cognitive impairment (MCI) that commonly occurs following coronary artery bypass graft (CABG) surgery.