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DewDiligence

05/26/16 4:43 PM

#201616 RE: DewDiligence #201405

AVIR halts enrollment for safety issue in phase-2a RSV trial:

http://finance.yahoo.com/news/aviragen-therapeutics-provides-phase-2a-203000441.html

Aviragen Therapeutics, Inc. (formerly Biota Pharmaceuticals, Inc.)…today announced that it has voluntarily decided to delay further enrollment in the Phase 2a trial of BTA585 for the treatment of RSV infections being conducted in the U.K. This decision emanated from a lab report from one subject showing an increase of a cardiac enzyme level coupled with transient ECG changes, which led to a hospitalization of less than 24 hours. The subject’s ECGs were normal prior to hospitalization and the cardiac enzyme levels returned to baseline shortly thereafter.

The FDA has placed the BTA585 IND on clinical hold, although AVIR is not currently conducting any clinical trials of BTA585 in the US.