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Current | 2007 | 2006 | 2005 | 2004 | 2003 | 2002 | 2001 | 2000 Celera Genomics Initiates Phase I Clinical Trial for Cathepsin S Inhibitor for the Treatment of Psoriasis ROCKVILLE, MD - September 20, 2005 Celera Genomics (NYSE:CRA), an Applera Corporation business, today announced the initiation of Phase I clinical testing for its cathepsin S inhibitor, CRA-028129, for the treatment of psoriasis. In the Phase I trial, healthy volunteers will be randomized to receive orally-administered CRA-028129 or placebo. The dose amount and number of days of dosing will be escalated in sequential cohorts of study subjects in order to characterize the pharmacokinetic and maximum pharmacodynamic effects of CRA-028129. Approximately 70 subjects will be enrolled in this study. This is a single center study being conducted at the Christchurch Clinical Studies Trust (CSST) in Christchurch, New Zealand. The initiation of this study follows approval from the New Zealand Director General of Health on the recommendation of the Standing Committee on Therapeutic Trials (SCOTT). SCOTT is a committee of the Health Research Council of New Zealand (HRC) which is convened to assess the scientific validity of applications for clinical trials. The study has also been approved by an HRC accredited ethics committee. "The regulatory and ethical standards required in New Zealand fully meet or exceed the International Conference for Harmonisation (ICH) and United States Food and Drug Administration guidelines for Phase I trials," said James Yee, M.D., Ph.D., Vice-President and Head of Development of Celera Genomics. "The quality of clinical science and operations at CCST, and its proven performance in adhering to Good Clinical Practices assures that results from this healthy volunteer study will be considered a valid basis to judge the suitability of CRA-028129 for future international Phase II clinical development." "We're pleased with the progress we've made in advancing our cathepsin S inhibitor through to this clinical development stage as a potential new treatment for psoriasis. Through our preclinical research we have identified two biomarkers of cathepsin S inhibition that we will use during our clinical trials as indicators of the pharmacodynamic behavior of this compound," said Robert Booth, Ph.D., Chief Scientific Officer of Celera Genomics. "Current treatments for psoriasis fail to induce permanent remissions, have the risk of unwanted adverse effects and/or are inconvenient to administer. CRA-028129's novel mechanism of action with the potential as an oral therapeutic provides an opportunity to improve on one or more of these unmet medical needs. Additionally, we believe that inhibition of cathepsin S could provide benefit in a number of other autoimmune diseases." Celera Genomics has designed and synthesized extremely potent and selective compounds which demonstrate picomolar inhibitory potency against the cathepsin S enzyme and which also show inhibitory activity in cell systems in the nanomolar range. Celera Genomics has a number of additional cathepsin S inhibitors from different chemical templates. These are proceeding through preclinical evaluation. "With today's accomplishment, coupled with the recent initiation of a Phase I study of our novel histone deacetylase (HDAC) inhibitor in cancer, we're pleased to have two unpartnered compounds currently undergoing clinical trials," said Kathy Ordoņez, President of Celera Genomics. "As we have previously announced, we are seeking partners to assist us in capitalizing on our small molecule capability and pipeline which, as evidenced by these developments, continues to advance." About Psoriasis and cathepsin S
There is considerable evidence that the immune system is involved in the pathogenesis of psoriasis1, 2. Cathepsin S is a cysteine protease which is expressed in certain antigen presenting cells and has been implicated in the presentation of antigens to CD4+ T cells. Inhibition of cathepsin S may reduce antigen presentation within certain antigen presenting cells and may therefore have a beneficial effect in the treatment of psoriasis. CRA-028129 was discovered and developed by Celera Genomics as part of a proprietary non-partnered program to develop inhibitors of cathepsin S. About Celera Genomics and Applera Corporation
Forward-Looking Statements
Copyright Š 2005. Applera Corporation. All Rights Reserved. Applied Biosystems, Celera, Celera Diagnostics, Celera Discovery System, and Celera Genomics are trademarks of Applera Corporation or its subsidiaries in the U.S. and/or certain other countries. 1. Ghoreschi K & Rocken M (2004). Immune Deviation Strategies in the Therapy of Psoriasis. Current Drug Targets - Inflammation & Allergy, 3(2): 193-198.
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