XBIT up after good clinical data

recent positive results on colorectal cancer study is driving xbit stock up - bullish

You should look into the science behind this company, pretty solid check out xbit - or biotech.com

 

01.08.16 - XBiotech Reports Additional Positive Data from Phase III European Trial of Xilonix™ in Advanced Colorectal Cancer [/COLOR]

Conference Call and Live Audio Webcast Scheduled for Today at 8:30 a.m. ET

XBiotech (NASDAQ: XBIT), developer of True Human™ therapeutic antibodies, today announced that it has completed data analysis for its Phase III European study and will hold a conference call to provide additional important information regarding the activity of Xilonix™ in the treatment of advanced, symptomatic colorectal cancer.

In addition to previously announced positive results regarding the primary endpoint of the pivotal study, complete data analysis further demonstrated that key secondary measures of antibody activity were also improved. Inhibition of IL-1 alpha on the surface of platelets may represent an important anti-tumor, disease-modifying activity, due to the mechanism of action of Xilonix. In the study, median platelet counts among placebo patients were found to be increased 5-fold compared to patients who received Xilonix, whose platelet counts remained near baseline levels during the treatment cycle (p=0.003).

Furthermore, while the study was not powered to demonstrate differences in serious adverse events (SAEs) between treatment and placebo groups, there was a 26% reduction in the risk of SAEs in the treatment arm relative to placebo (p=0.062). A treatment-related reduction in SAEs compared to placebo patients is a remarkable and important finding. An SAE is defined as a health-related event that is life-threatening, results in persistent or significant disability, or death. This may be the first report of a placebo controlled, randomized clinical study of an anticancer agent where there was reduced incidence of SAEs in a treatment arm. Finally, patients in the treatment arm were found to be 53% more likely to have stable disease compared to placebo at eight weeks (p=0.12).

The trends toward reduced disease progression and a reduction in SAEs is compelling given the small patient population in the study. Together, the Company believes that these secondary findings corroborate the therapeutic value of the antibody in advanced, recalcitrant cancer.

John Simard, CEO of XBiotech, stated, "We believe this study serves as a confirmation that Xilonix is a unique anti-cancer agent for gently treating advanced, even fragile cancer patients. We are also very proud that the study represents a milestone in the development of new clinical endpoints to assess efficacy of novel treatments that help heal patients with advanced disease."

The study included only patients with advanced disease with multiple symptoms that were prognosticators of poor outcome. The study was thus performed on a narrowly defined group of patients living with advanced colorectal cancer. The objective response criteria that constituted the primary endpoint were based on findings of a previous study in advanced cancer patients where antibody therapy was associated with recovery from key disease-related symptoms, including objective findings of increased lean body mass (LBM), and recovery from appetite loss, fatigue and pain. The Company collaborated with the Scientific Advisory Group of the European Medicines Agency (EMA) to use these earlier observations to establish novel objective response criteria to enable evaluation and potential registration of a cancer therapy. Thus the present findings of the Phase III study are believed to provide the first evidence that: (1) new endpoints based on symptom recovery may be used to evaluate an anti-tumor agent in advanced cancer; (2) in patients with advanced cancer, clinical trajectory can be positively altered in the presence of recalcitrant tumor; and (3), Xilonix, a True Human antibody therapeutic, represents a novel treatment for a serious unmet medical need in advanced colorectal cancer.

 

cool. With The new positive results on the cancer study, and the FDA fast track on other candidate treatments i think that XBIT is a pretty safe buy in the long run.
I have a close personal relationship (not financial) with the ceo of the company Xbiotech.
I can tell you that it is a very real company with some real ideas.
its the only company on the market with a completely human antibody- not one derived from an animal or plant.
A revolutionary manufacturing process that cuts costs usually seen by larger biotech companies.
Its biggest problem is being a small fish in a big pond. Having to deal with the short sellers and investment banker lawyers.

but if you have any specific questions for the company, just let me know i can ask the ceo directly and get back to you.

 

this has been little talked about in the mainstream but Xbiotech developed the first effective fully human ebola therapy

11.09.15 - XBiotech Announces Positive Results for its Anti-Ebola Therapeutic Candidates Following Evaluation by USAMRIID

XBiotech (NASDAQ:XBIT), the world’s leading developer of True Human™ therapeutic antibodies, announced today positive results for its True Human antibody therapeutic against Ebola virus infection. The results were part of the Company’s collaborative research with the United States Army Medical Research Institute of Infectious Diseases (USAMRIID). USAMRIID tested the Company’s recently developed therapeutic antibodies for their ability to neutralize live virus. The results showed that 8 out of 10 of the antibodies tested were able to effectively neutralize the Ebola virus.

The Company discovered the anti-Ebola therapeutic antibodies from blood donations it received earlier this year from convalescent patients who had recovered from Ebola virus infections. Once infected by the virus, patients who survive develop natural antibodies that can protect against further infection with the virus. The Company thus used blood from individuals recovered from Ebola virus infection to identify natural antibodies that neutralize the virus. The Company claims that the therapeutic antibodies tested by USAMRIID are the only true human therapeutic antibodies developed against the Ebola virus outbreak that peaked in Africa in 2013-2014 and that also infected patients in the USA and Europe. The Company has also already developed production capability for these therapeutic antibodies that could be used in large scale manufacturing.

Dr. Pamela Glass, Chief, Viral Biology Department, USAMRIID, who supervised the testing of identified antibodies, said, “These studies demonstrate the capability of the True Human platform to identify functional antibodies from survivors of Ebola or any biological agent infection.”

Dr. Sushma Shivaswamy, Vice President of Research and Development at XBiotech, stated, “We launched the discovery program only earlier this year to clone candidate therapeutic antibodies from Ebola-recovered patients. It is gratifying to now confirm that these antibodies indeed neutralize virus, proving again the powerful potential of our True Human antibody platform. Of course these findings today would not be possible without the courageous work from the USAMRIID scientific team, whose work with live Ebola virus confirmed the neutralizing activity of these antibodies. We are eager to make this candidate therapy available to help relieve suffering from this devastating virus.”

 

10.01.15 - XBiotech Receives FDA Fast Track Designation for its Novel True Human™ Therapeutic Antibody for Treating Serious Infections Due to Staphylococcus aureus

XBiotech (NASDAQ: XBIT), the world’s leading developer of next-generation True Human™ therapeutic antibodies, announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for its novel True Human monoclonal antibody therapy intended to treat all forms of Staphylococcus aureus infections, including Methicillin-resistant S. aureus (MRSA).

XBiotech’s antibody therapy, known as 514G3, is currently being evaluated in a Phase 1/2 clinical study and was developed from a human donor with natural antibodies effective at neutralizing MRSA and non-MRSA forms of S. aureus. 514G3 knocks out the principle immune evasion mechanism of the bacteria, allowing white blood cells to detect and destroy the bacteria. 514G3 is expected to treat all strains of MRSA and can be used without consideration for strain-specific resistance to various antibiotics. As a True Human monoclonal antibody, 514G3 is expected to be well tolerated without the side effects or risks of antibiotics.

John Simard, the Company’s Chief Executive Officer, said, “Receiving FDA Fast Track Designation highlights the importance for this product candidate to treat life-threatening bacterial infections. We look forward to reporting on further developments as this important program continues to generate clinical findings.”

 

Just found that XBio is named in a class action lawsuit by several firms.


I am not allowed to post links or copy and paste anything, so I can't provide further info easily.

 

ya if you look at what they are suing for its financial loss. Basically some investors who put a little money in the company and when there was a hiccup in the colorectal cancer study and the companies value went down below the original stock value, they started suing.
The company has some pretty big private investors and should be able to withstand any class action lawsuit that can be thrown at them. The data is looking really good , theres a lot of potential candidate drugs , some being fda fast tracked. an potential ebola ,staph treatment. I think the future for Xbiotech is bright

 

[h=1]XBiotech Engages in Research for Heart Attack Antibody Therapy[/h]

AUSTIN, Texas, Feb. 11, 2016 (GLOBE NEWSWIRE) -- XBiotech Inc. developer of True Human™ therapeutic antibodies, announced today the signing of a Material Transfer Agreement (MTA) with Brigham and Women’s Hospital and Massachusetts General Hospital. XBiotech will provide Antibodies to block the inflammatory mediator interleukin 1 alpha while Novartis Pharmaceuticals will provide an interleukin 1 beta antibody to a research team headed by cardiovascular medicine specialist Dr. Peter Libby. The research team will conduct pre-clinical studies to assess the potential of these antibodies to reduce injury to the heart muscle after heart attack and to calm inflammation in atherosclerotic plaques.
​

Dr. Libby, a cardiovascular medicine specialist at Brigham and Women’s Hospital (BWH) and the Mallinckrodt Professor of Medicine at Harvard Medical School (HMS), is the principal investigator of the research project. He has authored more than 370 peer-reviewed articles related to his interest in atherosclerosis and preventative cardiology. Dr. Libby’s research includes studying the messengers created by the body that may produce arterial plaque and blockages. Dr. Libby has received research recognitions on four continents including the highest basic research awards from the American Heart Association and American College of Cardiology, the Gold Medal of the European Society of Cardiology, and the Anitchkow award from the European Atherosclerosis Society.​

Dr. Libby stated “I have researched IL-1’s cardiovascular actions for many years, and am excited about the opportunity to be able to inhibit selectively IL-1 isoforms experimentally to define their roles and thus inform the design of future clinical trials targeting IL-1 in cardiovascular diseases.”​

John Simard, the Company’s Chief Executive Officer, commented, “Dr. Libby’s pioneering work to explore the role of inflammation in cardiovascular disease has been inspirational to our endeavors. Indeed the body of evidence he has generated during his remarkable career forms a key basis to XBiotech’s rationale for using its inflammation-blocking antibody therapy to treat vascular disease. This collaboration is intended to extend these observations by evaluating the role of antibody therapy in reducing injury to heart muscle associated with heart attacks.”​

MABp1 has been in a number of human clinical trials. XBiotech has reported that the antibody therapy has shown promising results in a Phase II randomized study, where the therapy was used to reduce major adverse cardiovascular events and restenosis to the blood vessel after revascularization procedures. The therapy has been Fast Tracked by the US FDA for clinical development in this indication. The animal analogue, FLO1 is a monoclonal antibody that neutralizes the same inflammatory target, IL-1a, as MABp1, but specifically targets the murine form of IL-1a. The use of FLO1 allows it to be well tolerated and function within the animal immune system in a way that is analogous to MABp1 in humans.​