ANDS – I guess we now know why
the CEO wants out and why investors
were smart to not buy the explanation
offered on the CC two weeks ago.
(p.s. ThomasS: This is the drug you
said would make it difficult for IDIX
to compete in the HCV arena; I said
at the time that was one of your worst
calls and I still think that.) CC at 8am ET.
Anadys Pharmaceuticals Suspends Dosing of ANA975 in Hepatitis C Clinical Trial Pending Further Assessment of 13-Week Pre-Clinical Toxicology Studies
Monday June 26, 5:00 am ET
A Precautionary Measure Until Further Evaluations Can Be Made
Conference Call at 8:00 a.m. EDT Today
SAN DIEGO, June 26 /PRNewswire-FirstCall/ -- Anadys Pharmaceuticals, Inc. (Nasdaq: ANDS ) 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. [Doesn’t sound too convincing, IMO.]
ANA975, 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).
Webcast of Conference Call
Anadys will host a conference call today at 8:00 a.m. Eastern Daylight Time to discuss the suspension of dosing ANA975. A live webcast of the call is available online at www.anadyspharma.com. A telephone replay will also be available approximately one hour after completion of the call. To access the telephone replay, dial 888-286-8010 (domestic) or 617-801-6888 (international), passcode 63285430. The webcast and telephone replay will be available through July 10, 2006.
Anadys Pharmaceuticals, Inc., www.anadyspharma.com, is a biopharmaceutical company committed to advancing patient care by discovering, developing and commercializing novel small molecule medicines for the treatment of hepatitis, other serious infections, and cancer. The Company has core expertise in Toll-Like Receptor-based small molecule therapeutics and structure-based drug design coupled with medicinal chemistry. Anadys' clinical development programs include ANA975 for the treatment of HCV and HBV, and ANA380 for the treatment of HBV. In addition, Anadys' therapeutic platform is designed to advance a strong and continual pipeline of drug candidates into the clinic.