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Anadys/Novartis HCV Toll-Receptor Drug Study Stopped for Animal Toxicity ( I hope you all get this , the site is down so I am just emailing )

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Anadys/Novartis HCV Toll-Receptor Drug Study Stopped for Animal Toxicity“Anadys Pharmaceuticals Suspends Dosing of ANA975 in Hepatitis C Clinical Trial Pending Further Assessment of 13-Week Pre-Clinical Toxicology Studiesâ€Press Release Source: Anadys Pharmaceuticals, Inc.Monday June 26, 5:00 am ETA Precautionary Measure Until Further Evaluations Can Be MadeConference Call at 8:00 a.m. EDT TodaySAN DIEGO, June 26 /PRNewswire-FirstCall/ -- Anadys Pharmaceuticals, Inc. (Nasdaq: ANDS - News) announced today that it has suspended dosing hepatitis C virus (HCV) patients in its ongoing Phase 1b clinical trial with ANA975 pending additional analysis of recently obtained information from pre-clinical 13-week toxicology studies in animals.Preliminary analysis of this information revealed various new observations which appear consistent with intense immune stimulation in animals. Anadys and its collaborator Novartis are in the process of evaluating these observations to determine future course of action."Although we have not seen any serious adverse events in clinical experience with ANA975, the health and safety of patients are our first and overriding concern," said Kleanthis G. Xanthopoulos, Ph.D., Anadys' President and CEO. "Consequently, we are suspending this trial for appropriate reasons of precaution while we gain a greater understanding of this recently obtained information.""In collaboration with Novartis we will carefully evaluate these new pre-clinical observations in the context of all available information," said Steve Worland, Ph.D., Anadys' President of Pharmaceuticals. "We will work to determine the best path forward in future development, including dose-finding activities and potential modifications of clinical trial design.""We continue to believe that ANA975 is an effective immunomodulator and therefore a potentially promising agent for patients infected with hepatitis C virus, and look forward to working with Novartis to continue the program," said Dr. Xanthopoulos.About ANA975ANA975, which Anadys is developing in collaboration with Novartis, is the oral prodrug of isatoribine, a proprietary Toll-Like Receptor-7 (TLR7) agonist. TLR7 is a receptor that activates the innate immune system. Activation of innate immunity is known to be an important component of the human immune defense. ANA975 has been administered to more than 90 healthy volunteers in three completed Phase I trials (501, 502, and 503).

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