announced Tuesday an agreement with regulators in the U.S. and Europe that greenlights the company and partner
Johnson & Johnson
to begin a new phase III study of their experimental hepatitis C drug telaprevir.
The new study will test telaprevir with standard combination therapy in 650 hepatitis C patients who could not be cured with the currently approved drugs for the disease, pegylated interferon and ribavirin. These are difficult to treat patients, including patients known as "null responders," which means they did not respond at all to previous treatments.
Vertex and Johnson & Johnson, which are co-developing telaprevir, posted an
outline of this new study
, dubbed REALIZE, on the
Web site in June. Vertex shares fell at that time because the new phase III trial suggested that an early regulatory approval filing for telaprevir in 2009 for treatment-resistant patients was not in the cards.
As it stands now, Vertex and Johnson & Johnson won't likely seek approval for telaprevir until the second half of 2010, based on data from a separate phase III study of the drug in treatment-naïve hepatitis C patients.
Vertex and its partner have
previously released results
from a smaller study in treatment-resistant patients that showed telaprevir to be effective in attacking the virus that causes hepatitis C.
The new phase III study announced today will test two different regimens of telaprevir in patients who previously did not respond to conventional hepatitis C treatment with pegylated interferon and ribavirin.
The study differs from previous studies in that patients will be treated with two regimens of telaprevir for a full 48 weeks instead of the accelerated 24-week treatment cycle used for treatment-naïve patients.
In addition, one of the arms of the new study will see whether a "lead-in" treatment with interferon and ribavirin alone before dosing of telaprevir may improve overall cure rates.
Vertex and its partner are locked in a tight race with
to be the first with a new direct antiviral drug aimed at hepatitis C approved in the U.S. and Europe.
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