Guest guest Posted March 23, 2010 Report Share Posted March 23, 2010 About HCV and INX-189 INX-189- In January 2010, the Company announced it had completed the requisite Good Laboratory Practices (GLP) preclinical studies to support the filing of an investigational new drug application (IND) for INX-189. Based on the results of these studies, an IND and, subject to FDA review, initiation of a Phase I clinical trial of INX-189, continue to be anticipated in the first half of 2010. We anticipate that INX-189, a nucleotide polymerase inhibitor that we are developing to treat chronic hepatitis C infections, will also enter clinical development in the first half of this year. About HCV and INX-189Hepatitis C is a disease of the liver caused by the hepatitis C virus (HCV). It is estimated that approximately 4 million Americans and 170 million individuals worldwide are infected with HCV, the majority of which are chronic infections that can cause liver disease, cirrhosis and cancer, and is the leading cause of liver transplants in the United States.Inhibitex is developing a series of proprietary phosphoramidates, or protides, of nucleoside inhibitors that target the RNA-dependent RNA polymerase (NS5b) of HCV. Protides are designed to by-pass the rate limiting first step in the creation of nucleoside triphosphate, which is the active form that inhibits the virus. The Company believes that its protides possess several pharmacological advantages over nucleosides alone and potentially other nucleotide prodrugs, including greater potency, a rapid conversion into its active form in the liver and potentially less toxicity due to reduced systemic exposure of the nucleoside. INX-189, the Company's lead compound from this series, is a protide of a 2'-C-methylguanosine analogue that the Company believes is the most potent HCV nucleotide polymerase inhibitor described in the literature to date. The Company believes the results of preclinical studies of INX-189 to date support its potential as a highly potent, once-per-day oral therapy highly amenable to combination with other antivirals for the treatment of patients with chronic hepatitis C infection. About InhibitexInhibitex, Inc., headquartered in Alpharetta, Georgia, is a biopharmaceutical company focused on developing products to treat and prevent serious infectious diseases. In addition to FV-100, INX-189 and other HCV nucleotide inhibitors in preclinical development, the Company has licensed the use of its proprietary MSCRAMM® protein platform to Pfizer for the development of staphylococcal vaccines. Year End 2009 Financial ResultsFor the year ended December 31, 2009, the Company reported a net loss of $17.6 million, as compared to $13.2 million for 2008. Basic and diluted net loss per share for the year ended December 31, 2009 was $0.38, as compared to $0.31 for 2008. The increase in net loss and net loss per share in 2009 was primarily the result of higher research and development expense associated with the clinical development of FV-100 and the preclinical development of the Company's HCV nucleotide polymerase inhibitor program, including INX-189, lower revenues from a collaborative license and development agreement and lower net interest income, offset in part by a reduction in general and administrative expense. Continue Reading News Release For additional information about the Company, please visit www.inhibitex.com. http://Hepatitis Cnewdrugs.blogspot.com/2010/03/about-hcv-and-inx-189.html Quote Link to comment Share on other sites More sharing options...
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