16:27 , Feb 7, 2018 |  BC Innovations  |  Distillery Therapeutics

Cancer

INDICATION: Breast cancer Patient sample and mouse studies suggest inhibiting IL-1α or IL-6 could help treat HER2-positive breast cancer. In patient tumor samples, levels of IL-1α or IL-6 were associated with poor metastasis-free survival, and...
20:12 , Sep 22, 2017 |  BC Week In Review  |  Clinical News

CHMP reiterates negative opinion on XBiotech's Hutruo

EMA's CHMP reiterated its May negative opinion regarding an MAA from XBiotech Inc. (NASDAQ:XBIT) for Hutruo (Xilonix, CV-18C3, T2-18C3, RA-18C3, MABp1, CA-18C3) to treat symptoms of advanced colorectal cancer, including cachexia, saying the data provided...
19:11 , Jun 16, 2017 |  BC Week In Review  |  Clinical News

XBiotech discontinues Xilonix CRC trial

XBiotech Inc. (NASDAQ:XBIT) said it is discontinuing the Phase III XCITE trial of Xilonix (CV-18C3, T2-18C3, RA-18C3, MABp1, CA-18C3) to treat colorectal cancer in about 643 patients. An IDMC recommended the study's termination based on...
21:39 , Jun 9, 2017 |  BC Extra  |  Clinical News

XBiotech sags after discontinuing Xilonix CRC study

XBiotech Inc. (NASDAQ:XBIT) plummeted $6.22 (66%) to $3.20 after it said it is discontinuing the Phase III XCITE trial of Xilonix to treat colorectal cancer (CRC). An IDMC recommended the study's termination based on an...
19:52 , May 25, 2017 |  BC Week In Review  |  Clinical News

CHMP recommends against XBiotech's colorectal cancer candidate

EMA’s CHMP recommended against approval of an MAA from XBiotech Inc. (NASDAQ:XBIT) for Xilonix (Hutruo, CV-18C3, T2-18C3, RA-18C3, MABp1, CA-18C3) to treat symptoms of advanced colorectal cancer, including cachexia. CHMP cited lack of efficacy in...
23:20 , May 19, 2017 |  BC Extra  |  Company News

CHMP backs approval of Veltassa, other candidates

On Friday, EMA's CHMP recommended approval of several therapies, including hyperkalemia drug Veltassa patiromer, psoriasis drug Kyntheum brodalumab and schizophrenia treatment Reagila cariprazine . The committee also issued a negative opinion for colorectal cancer candidate...
14:36 , Apr 28, 2017 |  BC Week In Review  |  Clinical News

Hutruo regulatory update

XBiotech said EMA issued a negative “trend” vote for the company's MAA for colorectal cancer candidate Hutruo. The company said the vote means it is unlikely EMA’s CHMP will recommend the candidate at its May...
19:07 , Apr 21, 2017 |  BC Extra  |  Company News

XBiotech hammered after negative EMA vote

XBiotech Inc. (NASDAQ:XBIT) lost $6.79 (40%) to $10.23 on Friday after saying EMA issued a negative “trend” vote for the company's MAA for colorectal cancer candidate Hutruo ( Xilonix ). The company said the vote...
04:42 , Mar 3, 2017 |  BC Week In Review  |  Clinical News

Xilonix: Ph III Ongoing

An IDMC recommended continuation of the double-blind, placebo-controlled, U.S. Phase III XCITE trial evaluating IV Xilonix every 2 weeks plus best supportive care (BSC). The review was the first of 2 planned interim efficacy analyses...
22:22 , Dec 21, 2016 |  BC Week In Review  |  Clinical News

Xilonix regulatory update

XBiotech said it received Day 180 questions from EMA’s CHMP related to the review of an MAA for Xilonix to treat advanced colorectal cancer. The company said CHMP raised major objections pertaining to the benefit-risk...