Wednesday, October 05, 2016 1:14:45 PM
JOE SHAN (VP/Clin.&Reg. Affairs) – CLINICAL TRIALS:
“As Steve has stated, we are very excited to have the opportunity for a late-breaking oral presentation on the Phase III SUNRISE trial at the ESMO Congress about a month from now [Oct7-11 http://www.esmo.org/Conferences/ESMO-2016-Congress SEE: http://tinyurl.com/jxdppyo ]. Even as the trial continues to wind down, treatment, follow-up, and data collection are still ongoing for a number of patients, with some continuing to receive bavituximab over a year. At ESMO, we will be presenting both topline clinical data from the trial as well as initial results from our ongoing biomarker analysis, the results of which have been promising to-date. Because these data have been accepted for presentation at ESMO, they are under embargo until the actual presentation, but we will provide addl. details on the ESMO presentation and our findings as soon as we can. As a reminder, the biomarker program was prospectively built into the SUNRISE protocol, and is designed to help us better understand how bavituximab works and which patients may benefit most. This is a massive effort, and though there are still much ongoing sample testing and data analysis, our goal is to share these results as they become available throughout the rest of this year and into 2017.” http://tinyurl.com/jydtkoy
Q&A:
STEVE KING: “As we get more and more information from the SUNRISE study, particularly the biomarker analysis, and other bits of information that will help guide the program… We’re trying to do is learn as much as we can from SUNRISE, because it's a great opportunity and it’s not often you get a set of data this big in which we had already prospectively built in a lot of biomarker and other types of analysis into the study. And we actually think that the data, even though it’s a docetaxel study, those results will be actually critical in advancing this in I-O combinations in the future as well. And so, it’s just gathering data, discussing the data that's available, but more data is literally coming to light on almost daily basis, it seems. And that's going to continue for the next few months.” http://tinyurl.com/jydtkoy
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