ANDS – ANA975 for HCV is back to the preclinical stage of development with a new formulation from NVS, but ANDS did not see fit to issue a press release to announce this. The following is from the company website (c/o Mike McFarland on SI).
On June 26, 2006, Anadys announced it had suspended dosing of patients with ANA975 in the then-ongoing Phase 1b trial of hepatitis C patients pending additional analysis of recently obtained information from 13-week animal toxicology studies. Subsequent to our decision to suspend dosing, the FDA placed the IND for ANA975 on full clinical hold.
Preliminary analysis of this information revealed various new observations which appear consistent with intense immune stimulation in animals. No serious adverse events have been seen in ANA975 clinical trials to date, and there were no clinical findings that contributed to the decision to suspend the Phase Ib trial.
Anadys in collaboration with Novartis Pharma AG plan to initiate a new 13-week pre-clinical toxicology study of ANA975 to assess safety and tolerability in animals. The new study is expected to utilize a new crystalline form of ANA975, developed by Novartis, which will further our understanding of the toxicology profile of ANA975. <<
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