ANDS may not meet their objective in this new study.
ANA975 in a New 13-Week Pre-Clinical Toxicology Study Using Crystalline Form
Tuesday November 7, 6:00 am ET
A Key Step Towards Objective of Re-initiating Clinical Trials
SAN DIEGO, Nov. 7 /PRNewswire-FirstCall/ -- Anadys Pharmaceuticals, Inc. (Nasdaq: ANDS - News) announced today that it has initiated in collaboration with Novartis Pharma A.G ("Novartis") a new 13-week pre-clinical toxicology study of ANA975 to assess safety and tolerability in animals. The recently initiated study, which utilizes a new crystalline form of ANA975 developed by Novartis, should further the understanding of the toxicology profile of ANA975.
"The Anadys and Novartis joint development team has been working diligently over the summer to gain a better understanding of what occurred in the initial 13-week toxicology study in animals," said Steve Worland, Ph.D., Anadys' President, Pharmaceuticals. "While lymphocyte proliferation is an expected consequence of TLR7 activation, we wish to better understand the extent of this proliferation and its reversibility. This new study, which will explore proliferation and reversibility at multiple doses, should provide information helpful to our objective to resume dosing ANA975 in clinical trials."
In June 2006, Anadys suspended dosing in its ANA975 Phase 1b trial in patients with chronic hepatitis C pending additional analysis of recently obtained information from pre-clinical 13-week toxicology studies in animals. Preliminary analysis of that information revealed various new observations which appear consistent with intense immune stimulation in animals. Subsequently, the ANA975 IND was put on full clinical hold by the U.S. Food and Drug Administration. There have been no serious adverse events in humans during the Phase 1b trial. All adverse events have been mild to moderate and have not posed any safety concerns to date, and there were no clinical findings that contributed to the decision to suspend the Phase Ib trial.
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