XOMA Corporation (NASDAQ:XOMA)
EYEGUARD-B Communication Plan Update Conference Call
June 30, 2014 4:30 PM ET
Ashleigh Barreto – Head-Investor & Media Relations
John W. Varian – Chief Executive Officer & Director
Good afternoon, ladies and gentlemen and welcome to XOMA Corporation's Conference Call. All participants are in a listen-only mode. As a reminder, this call is being recorded.
I would now like to turn the conference over to your host for today, Ashleigh Barreto, Investor Relations at XOMA. You may begin.
Thank you, Thank you, Operator, and good afternoon, everyone. Before we begin, I'd like to remind everyone this conference call will contain forward-looking statements about the company. These statements are subject to risks and uncertainties that could cause actual results to differ.
Please note that these forward-looking statements reflect our opinions only as of the date of this call, and we undertake no obligation to revise or publicly release results of any revisions to these forward-looking statements in light of new information or future events. Factors that could cause our actual results or outcome to differ materially from those expressed in or implied by such forward-looking statements are discussed in greater detail in our most recent filings of Form 10-K and other SEC filings.
Before you try to enter the queue, please know we will not be taking questions today. I would now to turn the call over to John Varian, XOMA’s Chief Executive Officer.
John W. Varian
Thank you, Ashleigh. I would like to thank everyone for joining us. Today’s call will be very quick. We just wanted to be sure there is a consistency in understanding on a couple of items related to the EYEGUARD-B study. EYEGUARD-B is being conducted outside the U.S. by our partner Servier. It is a study of gevokizumab in patients with Behçet’s disease and a history of non-infectious uveitis exacerbations.
During our recent investor meetings, questions as to how we’ll communicate the results of EYEGUARD-B as well as some questions on the statistical plan came up quite often. We wanted to address those today to provide clarity.
When we conducted our first quarter call in early May, 75% of the predefined exacerbations had occurred and the pace of exacerbations was on target to be achieved by the end of June. We’ve learned from Servier that as we entered the spring months, the exacerbation pace has slowed.
We can’t read anything into this, as each patient is unique and exacerbates at his or her own rate. We’ve talked with physicians and have been told that Behçet’s uveitis exacerbations are somewhat seasonal with the summer months being a time when they see fewer exacerbations. Exacerbations continue, and we’re still waiting for a handful of exacerbations to occur.
I accepted long ago, that while I can control or influence many things, controlling when a patient exacerbates is not one of them. I can’t make them happen and Servier can’t make them happen. This is “Finger of God” stuff. So we are close, but not there yet. In recent meetings we’ve been asked about our plans to communicate when the last exacerbation occurs. I want to confirm today that we will let you know through a press release. So that addresses the first question we’ve been getting.
The second question has to do with the statistical assumptions of the EYEGUARD-B study. EYEGUARD-B is an events driven study that compares the time to first exacerbation between the gevokizumab and placebo treated groups as their steroids are tapered. The study protocol allows enrollment of up to 110 patients, but our powering assumptions call for a significantly smaller number of patients. Servier has achieved the targeted enrollment supporting our assumptions although, enrollment continues until the last exacerbation is observed.
Servier derived the power assumptions for EYEGUARD-B from a literature review and in consultation with the key opinion leaders in Behçet’s uveitis. The targeted sample size was based on a hazard ratio of 0.3 or .3 exacerbations in the gevokizumab group for each exacerbation in the placebo-treated group. A simple way to look at this is: for every person receiving gevokizumab who exacerbates, the study assumes just over three people in the placebo arm will have exacerbated.
The primary endpoint will be reported as the difference in time to first acute ocular exacerbation between the placebo and gevokizumab treated groups. This difference will be estimated from the statistical comparison of the survival curves. The curves that will be generated will show the number of non-exacerbating patients over time, using a Cox’s proportional hazard model. Our assumptions will provide 90% power at a p-value of less than or equal to 0.05.
Before we close, to ensure everyone is clear on what will happen after we announce the targeted final exacerbation has occurred, I will remind you that Servier is 100% responsible for conducting the EYEGUARD-B study. They control when they lock the database. They will take the time they need to review and clean the data to ensure all of the patient information is included and any discrepancies are investigated and resolved.
This will all occur prior to unmasking the study and running the endpoint analysis which we will be part of. They have communicated that they will work hard to have the primary endpoint data about six weeks after the final event. The results from EYEGUARD B are right in front of us, but the final event will occur when it does. We’ll communicate that to you through a press release.
Thank you for joining us today, we look forward to speaking with you again in August during our second quarter conference call. Thank you everyone.
Ladies and gentlemen, that does conclude the conference for today. Again, thank you for your participation. You may all disconnect. Have a good day.
[No Q&A session in this event]
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