d pharmacokinetic profile of BCX-4208.
Secondary objectives include assessment of pharmacodynamic measures and
clinical response. The planned interim analysis of the Phase IIa trial
included 30 patients divided evenly across the three study arms. The safety
analysis includes follow-up on all 30 patients. Of the 30 patients
evaluated for efficacy, 18 patients completed all 6 weeks of dosing. The 12
patients who discontinued prior to completing 6 weeks of dosing were
equally distributed across the three arms of the study.
In an ongoing Phase I multiple ascending dose study, BCX-4208 showed a
dose response effect on reducing lymphocyte counts at doses up to 1040mg
administered once daily for 7 days. Interim data from the ongoing Phase IIa
study at 20mg and 120mg showed similar dose-dependant effects on reduction
of peripheral blood lymphocyte counts. Affected lymphocyte subsets in the
Phase II study included CD4+, CD8+, CD56+, and CD20+ cells.
"While Roche's decision is disappointing, we are very encouraged by the
effects on lymphocyte counts that we are seeing with BCX-4208. Similar
activity with other experimental and marketed drugs has been associated
with clinical efficacy in the treatment of various autoimmune diseases.
Together with the good safety and tolerability profile of BCX-4208 observed
to date, these data provide a strong scientific rationale for continuing to
explore the activity of BCX-4208 in the treatment of autoimmune diseases,"
Mr. Stonehouse commented. "We look forward to evaluating the final data
from the full cohort of 66 subjects later this year."
Conference Call and Webcast
The Company will sponsor a conference call at 8:30 a.m. Eastern Time on
May 8, 2008 to discuss the financial results and the status of each of our
programs in more detail. This call is open to the public and can be
accessed live either over the Internet from http://www.biocryst.com or by dialing
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SOURCE BioCryst Pharmaceuticals, Inc. Copyright©2008 PR Newswire. All rights reserved | |
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