tell whether patients will live three times longer or not.”
When asked to comment about Venook’s criticism, Simard reacted with sarcasm: “OK, thanks guy, then I’m glad you’re on board.”
Xbiotech has not yet published the full data from the trial. The data under fire were an overview, but Simard said that critics like Venook shouldn’t need additional data to understand Xbiotech’s positive view of the study.
“We had to formally show they’re living longer, but what we show is that the response is related to the drug,” Simard said. “That’s a pretty simple concept. How can you malign that?”
Simard attributed criticism of the data to stock manipulators. In the first two trading days after the company’s July 2 statement, the stock price fell 42 percent.
Simard also addressed criticism that moving patients from placebo to the drug—a practice called “crossover”—made it difficult to interpret side effects and other elements of the trial. Simard said providing patients a placebo is a “cruel thing to do” and crossovers should in fact happen more frequently in trials. Xbiotech moved placebo patients to the drug arm after eight weeks. Simard remained steadfast that the overall survival data holds value.
“They’re living three times as long,” he said. “Clearly we got the disease under control somehow.”
When asked when the full Phase 3 data will be published, Simard said that it is currently under review at a “top” scientific journal. In addition to colorectal cancer, Xbiotech is studying its treatment for multiple other conditions, including other cancers.
Xbiotech currently leases two buildings near the Austin-Bergstrom International Airport to produce its drugs. It is building a new facility, which it expects to move in to later this year. The company raised $76 million in an initial public offering in April 2015.
