XBIOTECH INC. (NASDAQ:XBIT) Files An 8-K Other Events
Item 8.01. Other Events.
Phase III Second Interim Analysis Outcome
On June 9, 2017, XBiotech Inc. (the Company) announced that an
Independent Data Monitoring Committee (IDMC) has performed its
second prospectively planned, unblinded analysis of the Phase 3
XCITE study for the Companys novel candidate antibody therapy for
the treatment of colorectal cancer. The IDMC recommended the
early termination of the study since the findings were not
sufficient to meet efficacy or the threshold for continuation,
which involved a prospectively defined acceptance boundary for
the interim analysis of less than or equal to p = 0.08.
A copy of the press release issued in connection with the
announcement is filed as Exhibit 99.1 to this Current Report on
Form 8-K.
This Form 8-K contains forward-looking statements, including
declarations regarding management’s beliefs and expectations,
that involve substantial risks and uncertainties. In some cases,
you can identify forward-looking statements by terminology such
as may, will, should, would, could, expects, plans, contemplate,
anticipates, believes, estimates, predicts, projects, intend or
continue or the negative of such terms or other comparable
terminology, although not all forward-looking statements contain
these identifying words. Forward-looking statements are subject
to inherent risks and uncertainties in predicting future results
and conditions that could cause the actual results to differ
materially from those projected in these forward-looking
statements. These risks and uncertainties are subject to
the disclosures set forth in “Risk Factors” in our SEC
filings.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits
| Exhibit Number | Description | |
| 99.1 | Press Release of XBiotech Inc., Issued June 9, 2017. |
About XBIOTECH INC. (NASDAQ:XBIT)
XBiotech Inc. is a clinical-stage biopharmaceutical company. The Company is engaged in discovering and developing True Human monoclonal antibodies for treating a range of diseases. The Company focuses on bringing its lead product candidate, Xilonix (MABp1), to market. The Company has also developed a True Human monoclonal antibody discovery platform and manufacturing system. The Company’s therapeutic antibody Xilonix is being evaluated as a monotherapy to treat advanced stages of colorectal cancer. Xilonix neutralizes a pro-inflammatory protein produced by leukocytes and other cells, interleukin-1 alpha (IL-1a). The Company completed a Phase I and II clinical trial for MABp1 as a treatment for cancer at MD Anderson Cancer Center. The Company is also investigating MABp1 in clinical trials for other indications, including vascular disease, type II diabetes, acne and psoriasis.