ChemoCentryx Initiates Phase II Clinical Trial of Traficet-EN in Inflammatory Bowel Disease; Results from Phase I Clinical Studies Confirm Once-Daily Dosing Regimen.MOUNTAIN VIEW, Calif. -- ChemoCentryx, Inc. today announced that the company is currently conducting a Phase II clinical trial Noun 1. phase II clinical trial - a clinical trial on more persons than in phase I; intended to evaluate the efficacy of a treatment for the condition it is intended to treat; possible side effects are monitored phase II to evaluate the safety and pharmacokinetics of one of the company's lead products, Traficet-EN(TM) (CCX (Cisco Compatible EXtensions) Specifications for makers of 802.11 wireless LAN chips for ensuring compliance with Cisco's proprietary wireless LAN protocols. For example, Cisco's LEAP and EAP-FAST are part of CCX. See EAP. 282), among patients with inflammatory bowel disease inflammatory bowel disease n. Abbr. IBD Any of several incurable and debilitating diseases of the gastrointestinal tract characterized by inflammation and obstruction of parts of the intestine. (IBD IBD abbr. inflammatory bowel disease Inflammatory bowel disease (IBD) Disease in which the lining of the intestine becomes inflamed. Mentioned in: Amebiasis IBD 1. ). Traficet-EN is a novel, orally bioavailable, anti-inflammatory agent that targets the chemokine receptor Chemokine receptor A receptor on the surface of some types of immune cells that helps to mediate entry of HIV into the cell. Mentioned in: AIDS known as CCR 1. CCR - condition code register. 2. CCR - (Database) concurrency control and recovery. 9. The receptor is on gut-homing inflammatory cells that are responsible for the persistent inflammation underlying both Crohn's disease Crohn's disease: see colitis. and ulcerative colitis ulcerative colitis Inflammation of the colon, especially of its mucous membranes. The inflamed membranes develop patches of tiny ulcers, and the diarrhea contains blood and mucus. (the two principal forms of IBD), where it controls the migration of these cells into diseased tissue. This Phase II clinical study has been designed to evaluate Traficet-EN's safety and tolerability among patients, and to monitor certain indicators of clinical activity. The study will enroll sixty patients with moderate to severe Crohn's disease and is being conducted in leading centers located in the U.S., U.K and the Netherlands. Patients will receive Traficet-EN in a capsule once daily for 28 days. "We have been very pleased with the excellent progress of Traficet-EN through preclinical and early-stage clinical development. Our Phase I clinical results were extremely encouraging, confirming our expectations that Traficet-EN's pharmacokinetic (PK) properties make it appropriate for once-daily dosing," said Thomas J. Schall, Ph.D., President and CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. of ChemoCentryx. "The compound's safety and PK profile, along with its novel mode of action, have attracted leading experts in gastroenterology to participate in our Phase II study. By developing an oral compound (versus biologics which are injected) with potentially fewer side effects Side effects Effects of a proposed project on other parts of the firm. than those seen with traditional IBD therapeutics, we hope to have a tremendous positive impact on patient care in IBD." In June of 2004, ChemoCentryx completed single dose and multiple dose Phase I studies of Traficet-EN in healthy volunteers to evaluate safety and pharmacokinetics. Results from these trials demonstrated the drug is well tolerated and appropriate for once-daily dosing. The company intends to present complete results from its Phase I clinical studies in a peer-review forum. About Traficet-EN Traficet-EN, a first-in-class small molecule drug, is designed to control the inappropriate immune response immune response n. An integrated bodily response to an antigen, especially one mediated by lymphocytes and involving recognition of antigens by specific antibodies or previously sensitized lymphocytes. underlying IBD. By selectively binding to CCR9, a chemokine receptor present on immune cells found in the large and small intestine and involved in the homing of T cells to these organs, Traficet-EN has been shown to be efficacious in models of Crohn's disease and ulcerative colitis. In preclinical studies, the compound worked both therapeutically and prophylactically. About Inflammatory Bowel Disease IBD is a chronic condition that features relapsing inflammation of the gastrointestinal tract. IBD consists of two forms -- Crohn's disease and ulcerative colitis -- and affects approximately 1.7 million patients in North America and Europe.(1) Currently, no cure exists for IBD, and, in the most severe cases, cumulative damage to the intestine can result in the need for surgical intervention. Despite the introduction of Tumor Necrosis Factor tumor necrosis factor n. Abbr. TNF A protein that is produced in the presence of an endotoxin, especially by monocytes and macrophages, is able to attack and destroy tumor cells, and exacerbates chronic inflammatory diseases. (TNF TNF abbr. tumor necrosis factor TNF, n an abbreviation for tumor necrosis f ) inhibitors, many patients do not respond to current treatment options, find them difficult to use, or will develop serious long-term side effects. As a small molecule taken orally once a day, ChemoCentryx's Traficet-EN is expected to provide advantages in terms of dosing, compliance, and cost over existing biologic therapeutics. About ChemoCentryx ChemoCentryx, Inc. discovers, develops and commercializes novel small molecule medicines for autoimmune diseases, inflammatory disorders and cancer. ChemoCentryx has advanced Traficet-EN, the company's orally-active drug for inflammatory bowel disease, into Phase II clinical trials. In addition to its independent programs, such as Traficet-EN, ChemoCentryx is currently engaged in two partnerships as well. ChemoCentryx and Amgen-SF collaborate on the development of compounds targeting the chemokine receptor CXCR CXCR Chemokine, CXC Motif, Receptor CXCR Alpha Chemokine Receptor 3, thought to be an important target for psoriasis and other inflammatory diseases. Separately, ChemoCentryx and Forest Laboratories entered into a collaboration to co-develop small molecule antagonists targeting the CCR1 receptor for the treatment of autoimmune diseases such as rheumatoid arthritis. Other independent programs at the company include development candidates for cancer and cardiopulmonary inflammation. Leveraging its leadership in chemokine-based drug discovery, ChemoCentryx focuses on new classes of orally-active small molecules to selectively inhibit activity of the chemokine chemokine /che·mo·kine/ (ke´mo-kin) any of a group of low molecular weight cytokines identified on the basis of their ability to induce chemotaxis or chemokinesis in leukocytes (or in particular populations of leukocytes) in inflammation. system, the "master regulator" of immune response. ChemoCentryx is privately held with headquarters in Mountain View, California For the census-designated place, see Mountain View, Contra Costa County, California. For other places called "Mountain View", see . Mountain View is a city in Santa Clara County, in the U.S. state of California. The city gets its name from the views of the Santa Cruz Mountains. . For more information on the company, visit www.chemocentryx.com. Any statements in this press release about ChemoCentryx's expectations, beliefs, plans, objectives, assumptions or future events or performance are not historical facts and are forward-looking statements. These statements are often, but not always, made through the use of words or phrases such as "believe," "will," "expect," "anticipate," "estimate," "intend," "plan," and "would." Forward-looking statements are not guarantees of performance. They involve known and unknown risks, uncertainties and assumptions that may cause actual results, levels of activity, performance or achievements to differ materially from any results, levels of activity, performance or achievements expressed or implied by any forward-looking statement. Some of the risks, uncertainties and assumptions that could cause actual results to differ materially from estimates or projections contained in the forward-looking statements include but are not limited to (i) the timing, success and cost of preclinical research and clinical studies, (ii) the timing, acceptability and review periods for regulatory filings, (iii) the availability of corporate partners, (iv) uncertainties relating to patent protection and intellectual property rights of third parties, (v) the impact of competitive products and technological changes, (vi) the availability of capital and the cost of capital, (vii) other vagaries in the biotechnology industry and (viii) other risks. ChemoCentryx undertakes no obligation to update or revise any forward-looking statements. (1) Source: DATAMONITOR, 2001. |
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