Idenix Pharmaceuticals Inc. Hepatitis C Drug Put on Partial Hold, Stock Plunges
CAMBRIDGE,
Mass., Aug. 16, 2012 (GLOBE NEWSWIRE) -- Idenix Pharmaceuticals, Inc.
(Nasdaq:IDIX), a biopharmaceutical company engaged in the discovery and development
of drugs for the treatment of human viral diseases, today announced that the
Company received verbal notice from the U.S. Food and Drug Administration (FDA)
that a partial clinical hold has been placed on IDX184, the Company's
nucleotide polymerase inhibitor under development for the treatment of
hepatitis C virus (HCV).
As a result
of the recent occurrence of a serious cardiac-related adverse event encountered
with a competitor's nucleotide polymerase inhibitor for the treatment of HCV,
the FDA has expressed an interest in further reviewing the safety of IDX184 and
has placed IDX184 on partial clinical hold. In previous clinical trials as well
as the ongoing phase IIb clinical trial of IDX184 in combination with pegylated
interferon and ribavirin (PegIFN/RBV), there has been no evidence to date of
cardiotoxicity in patients dosed with IDX184 with PegIFN/RBV beyond that seen
with PegIFN/RBV alone. There are currently no patients receiving IDX184
worldwide.
The FDA has
requested additional data on patients treated with IDX184. Patient safety is
our main concern and Idenix will immediately begin work to comply with the FDA
request and expects to submit these data to the FDA in the coming weeks. The
Company intends to have an ongoing discussion with the FDA following the
submission of this data.
ABOUT IDX184
IDX184 is an
unpartnered, novel, liver-targeted nucleotide prodrug of 2'-methyl guanosine,
which includes Idenix's proprietary liver-targeting technology. This technology
enables the delivery of nucleoside monophosphate to the liver, leading to the
formation of high levels of nucleoside triphosphate, potentially maximizing
drug efficacy and limiting systemic side effects with low, once-daily dosing.
The Company reported interim data in June 2012 for the first cohort of 31
patients from an ongoing phase IIb clinical trial of IDX184 in combination with
PegIFN/RBV. Of the patients who achieved an extended rapid virologic response
(undetectable levels of virus at 4 weeks and 12 weeks) and completed an additional
12 weeks of PegIFN/RBV (n=9), 100% of patients (4/4) in the 100 mg arm and 80%
of patients (4/5) in the 50 mg arm achieved a sustained virologic response four
weeks after the completion of treatment (SVR4).
In July 2012,
an independent data safety monitoring board reviewed the safety data for this
study and confirmed that the side effect profile of IDX184 combined with
PegIFN/RBV is consistent with that of PegIFN/RBV alone.
ABOUT PARTIAL CLINICAL HOLD
A partial
clinical hold is a delay or suspension of only part of the clinical work
requested under the investigational new drug (IND) application (e.g., a
specific protocol or part of a protocol is not allowed to proceed; however,
other protocols or parts of the protocol are allowed to proceed under the IND).
Under the partial clinical hold, Idenix cannot enroll patients into additional
clinical trials until agreement is reached with the FDA on the next
clinical trial design.
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