Re: Farmas USA
$SNSS: Sunesis Pharma to implement one-time sample size increase to Phase 3 VALOR trial in AML; DSMB recommendation triggers $25.0 mln investment in sunesis from Royalty Pharma (2.62)
Co announced that it will implement a one-time, 225-patient sample size increase to its Phase 3 VALOR trial of vosaroxin in acute myeloid leukemia, bringing target enrollment to 675 patients. This is in response to the recommendation of the trial's independent Data and Safety Monitoring Board following their completion yesterday of a single, pre-planned interim analysis of unblinded efficacy and safety data sets from VALOR. Royalty Pharma's $25.0 million investment is made pursuant to the terms of an agreement with Sunesis announced March 29, 2012. In exchange for their investment, Royalty Pharma will receive a 6.75% royalty on future net sales of vosaroxin and warrants to purchase Sunesis common stock. With the revised target sample size of 675 patients, Sunesis anticipates full enrollment of VALOR in 2013, with unblinding of the trial expected in the first half of 2014 upon reaching 562 events and final database lock. The DSMB recommendation also triggers Royalty Pharma's obligation to invest $25.0 million in Sunesis.
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