The forodesine HCl CTCL pivotal trial is enrolling as planned. This trial has been reviewed under a Special Protocol Assessment (SPA) from the United States Food & Drug Administration (FDA) to support regulatory approval.
BioCryst has also initiated a second clinical trial for patients with CLL based upon data presented at the December 2007 ASH meeting, which demonstrated the potential of forodesine HCl as a treatment for CLL, both as a single agent and in combination with bendamustine. This second CLL trial is a single-arm study evaluating single agent forodesine HCl as a treatment for patients with CLL; response rate is the primary endpoint. The first patient was dosed during the first quarter 2008, and BioCryst will provide a trial update by year end.
Intramuscular (i.m.) peramivir clinical development update
BioCryst initiated a Phase III i.m. peramivir trial early this year and
voluntarily discontinued it after 82 of the planned 600 patients had
enrolled because of a decision to pursue higher doses in a Phase II
setting. Patients with influenza A and B were treated with either placebo
or 300mg of i.m. peramivir. Although only 14% of the planned patients were
enrolled in the study, results supported the activity of 300mg peramivir.
The study was designed to show a difference within the influenza A
subgroup, where preliminary clinical data showed a 30 hour reduction in
time to alleviation of symptoms in patients that received peramivir
compared to those who received placebo. Preliminary results from the
overall population showed a reduction in time to alleviation of symptoms of
approximately 14 hours. Because the trial was not carried out to
completion, the sample size was small; the observed treatment effect was
not statistically significant.
These results are consistent with data from previous clinical trials:
-- Reductions in time to
|SOURCE BioCryst Pharmaceuticals, Inc.|
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