| CLINICAL STUDY |
A first generation CRF1 non-peptide antagonist that was previously in development with Janssen Pharmaceutica (R121919) was studied in a Phase IIa clinical trial. This study, conducted by Dr. Florian Holsboer, Director of the Department of Psychiatry at the Max Planck Institute in Munich Germany, treated two groups of 10 patients each suffering from major depression. Although the trial did not include a placebo group and involved too few patients to draw efficacy conclusions, a dose-related improvement in measurements of both anxiety and depression were noted in 80% of patients providing the first indications of a CRF1 receptor antagonist effect using a novel mechanism for major depression. These results, "The First Human Experience with CRF Antagonists" were published in the Journal of Psychiatric Research and have been presented at numerous scientific meetings since 2000. Independent of the Company's prior collaboration with Janssen, Co.'s proprietary CRF1 receptor antagonist program has yielded a number of high potency compounds from several novel chemical series, which are all distinct from previous "first-generation" compounds. From these, Co. has identified a number of lead candidates and based on both preclinical and early clinical studies, have demonstrated improved specificity and greater potency than the first generation compounds together with excellent pharmacokinetic properties. Based on the success and breadth of the CRF1 receptor antagonist program, Co. entered into a worldwide research, development and commercialization agreement with Partner Co. for Corticotropin Releasing Factor Receptor Antagonists (CRF1 and CRF2), to treat psychiatric, neurological and gastrointestinal diseases including anxiety, depression, irritable bowel syndrome (IBS), inflammatory pain, stroke and other neurodegenerative diseases (see Press Release July 24, 2001). Compounds from a number of different chemical classes are currently under investigation as potential clinical candidates. |
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