In addition BMS094 distribution appears to be far less liver targeted than IDX184. Finally in pre-clinical testing performed by Idenix, BMS094 exhibited significant cytotoxicity across a wide variety of cell types in sharp contrast to IDX184. The FDA has requested that Idenix perform additional cardiac testing of patients in the ongoing study.
This is a priority to us, as Idenix has always committed to ensuring the safety of our patients, Specifically we are initiating echocardiograms on nine patients with reported dyspnea in the ongoing Phase IIb study. These included one case of grade 3 dyspnea and 8 cases of cases of grade 1 dyspnea.
Of note dyspnea is a well known side effect of pegylated interferon and ribavirin. We expect to submit the data to the FDA in the coming weeks. Idenix also intends to engage in an ongoing dialog with the FDA and to seek the FDA's feedback on the necessary steps to remove the partial clinical hold.
At this point our timelines for advancing IDX184 are expected to be impacted by the partial clinical hold. Until we gain additional clarity from the FDA, we cannot predict potential delays in our clinical timelines with more certainty at this time.Patient safety is our main concern and we work quickly and diligently to address the FDA's concerns, but remain confident in the safety profile of IDX184. Idenix remains strongly committed to advancing (inaudible) or oral combination of direct acting antivirals to change the treatment paradigm of patients infected with HCV. With that I will now turn the call back to the operator to open the question-and-answer session. Question-and-Answer Session Operator (Operator Instructions) Our first question is from Geoff Meacham with JPMorgan. Geoff Meacham - JPMorgan Just got a couple here. Is it your sense from talking to FDA as the hold related to the fact that you have a somewhat similar structure, somewhat similar active metabolite or is it more to do with fact that you don’t have as many patients as say some other nucs in the space? Ron Renaud Read the rest of this transcript for free on seekingalpha.com
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