XBiotech

    XBiotech Receives FDA Fast Track Designation for Its Novel True Human(TM) Therapeutic Antibody for Treating Serious Infections Due to Staphylococcus Aureus

    AUSTIN, Texas, Oct. 1, 2015 (GLOBE NEWSWIRE) -- 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."

    XBiotech Announces Publication of Clinical Results Supporting the Potential of Its True Human(TM) Antibody as a Cardiovascular Therapy
    Results Published in the Journal of Vascular Surgery Suggest Potential to Target Inflammation to Treat Acute Vascular Injury

    AUSTIN, Texas, Oct. 2, 2015 (GLOBE NEWSWIRE) -- XBiotech (NASDAQ:XBIT), the world's leading developer of next-generation True Human™ therapeutic antibodies, announced publication of clinical results from a Phase 2 open label, randomized, parallel-group, multicenter study examining SFA restenosis in patients following successful percutaneous revascularization. The results, now available online as an "Article in Press" in the Journal of Vascular Surgery, point towards Xilonix's potential as a safe and effective therapy to preserve vessel patency after endovascular intervention. This program has previously been granted Fast Track Designation by the US FDA.


    In the article titled, "A Randomized Phase II Study of Xilonix, a Targeted Therapy Against Interleukin 1 alpha, for the Prevention of Superficial Femoral Artery Restenosis After Percutaneous Revascularization," XBiotech reported that researchers observed tendencies toward improved vessel patency and fewer major adverse cardiovascular events following dosing of MABp1 over a 3-month period.


    Hosam El Sayed, M.D., Ph.D., associate professor of surgery in the Division of Vascular Diseases and Surgery at The Ohio State University Medical Center and lead author, said, "The cardiovascular field has marked many advancements in recent years, and endovascular interventions to treat peripheral arterial disease have saved and improved many lives, however, the natural history of these lesions after intervention appears to be progression to restenosis. Even as initial reports on newer endovascular technologies have reported lower rates of restenosis of arteries in the lower extremities, a systemic pharmacologic approach to prolong the restenosis free duration would be a major step forward for the treatment of these patients."


    John Simard, President and CEO of XBiotech, added, "The pathological role of inflammation in atherosclerosis and acute vascular events is well established. We are excited to provide the first data that a therapeutic antibody may be used as a potentially safe and effective means to reduce restenosis and major adverse cardiovascular events following revascularization."


    The study enrolled a total of 43 patients with symptomatic, peripheral vascular disease. Upon successful percutaneous revascularization, patients were randomized to Xilonix or standard of care. Xilonix was administered intravenously immediately following revascularization, and every 2 weeks intravenously for 3 additional doses, with additional subcutaneous doses administered monthly. The major efficacy endpoints were target vessel restenosis and incidence of major adverse cardiovascular events (MACE). At 3-month follow-up, which covers the intravenous dosing period, a trend toward lower incidence of restenosis (0/22 [0%] vs. 2/21 [10%], p=0.14) and MACE (2/22[9%] vs. 5/21 [24%], p=0.22) was observed in the Xilonix cohort. Adverse events were equally distributed in both arms.

    Yetichris hat am 19.10.2015 - 21:24 folgendes geschrieben:

    Quote

    diese nachrichten sind doch nicht so schlecht, dass der kurs so zusammenbricht?! Verstehe ich da was falsch??? Kann mir jemand helfen?

    Klar waren es gestern gute News. Erklären kann ich mir den Einbruch auch nicht...


    XBIT ist halt mit Ihrem kleinen Volumen von ca. 100'000 mit wenigen Käufen / Verkäufern übermäßig bewegbar.

    Vom 21.10.15 jedoch Kurstechnisch ohne Einfuss

    XBiotech Presents Findings at Investigator Conference for Staphylococcus Aureus Program

    BIOTECHNOLOGY, Oct. 21, 2015 (GLOBE NEWSWIRE) -- XBiotech (XBIT), the world's leading developer of next-generation True Human(TM) therapeutic antibodies, announced that it held an investigator conference on October 14th in Austin, TX for its Phase 1/2 clinical study of a novel True Human monoclonal antibody therapy intended to treat all forms of Staphylococcus aureus infections, including methicillin-resistant S. aureus (MRSA). The Company says clinical data were presented that it believes provides evidence that the therapy can work in patients to mediate immune clearance of S. aureus. XBiotech says it plans to submit these data to the FDA as it refines its Fast-Track development strategy for the therapy.


    The Company presented findings that showed a direct correlation with the pharmacokinetics of its antibody therapy and the ability of patient blood to mediate clearance of S. aureus.

    XBiotech hosted 30 attendees, including doctors, nurses and coordinators from five participating sites and others responsible for the administration of the trial. The conference featured a talk by Dr. Mark E. Rupp, Principal Investigator of the study, on the growing impact of S. aureus bacteremia in the United States, the devastating consequences of the disease in terms of mortality and morbidity, and the need for new therapies. Dr. Rupp, a world expert on S. aureus infections, is Professor and Chief, Division of Infectious Diseases and Medical Director of the Department of Infection Control & Epidemiology at the University of Nebraska.

    Dr. Rupp commented, "Infection due to Staphylococcus aureus is a very significant clinical problem that results in a substantial amount of death and suffering on a worldwide basis. The ongoing emergence and spread of multi-drug resistant S. aureus, including MRSA, clearly indicates a critical need for novel, non-antibiotic, adjunctive and preventive therapy. The anti-S. aureus monoclonal antibody 514G3 shows great promise in laboratory and in-vivo experiments and may be just what is needed to combat serious infections due to S. aureus. This novel product deserves serious and thorough scrutiny."

    John Simard, President and CEO of XBiotech, stated, "Early clinical data has provided compelling evidence that the antibody therapy can play a crucial role to enable elimination of S. aureus by the immune system. We were inspired by the keen interest in the therapy that we witnessed among clinical investigators. We are working diligently to build on our findings to advance the clinical program as quickly as possible to address the urgent need for an S. aureus therapy."

    The randomized, placebo-controlled, Phase 1/2 study is designed to evaluate dosing, safety and efficacy of 514G3 and will enroll 52 patients at approximately 16 clinical sites in the United States, Europe and Asia. Hospitalized patients with S. aureus bacteremia will be randomized to receive 514G3 plus standard of care antibiotics or placebo plus standard of care antibiotics. The study will be unblinded during the Phase 1 dose escalation stage, where the maximum tolerated dose will be determined, followed by a double-blinded Phase 2 study designed to further assess safety and efficacy. Efficacy measures include time to clearance of bacteremia, as measured by blood culture, duration of fever and length of hospitalization. For more information about the study, visit www.clinicaltrials.gov.

    XBiotech Initiates Program to Develop Antibody Against Clostridium Difficile
    Program to Potentially Create First Oral Monoclonal Antibody Against C. Difficile Bacteria

    AUSTIN, Texas, Oct. 26, 2015 (GLOBE NEWSWIRE) -- XBiotech (NASDAQ:XBIT), the world's leading developer of next-generation True Human™ therapeutic antibodies, announced today the launch of a research and development program to develop a first-in-class oral monoclonal antibody against Clostridium difficile (C. difficile) infection. Using its proprietary True Human technology, the Company has begun screening human blood samples from donors to identify and clone a therapeutic antibody candidate from individuals with natural immunity to C. difficile infection.


    C. difficile is the causative organism of antibiotic-associated pseudomembranous colitis, a potentially devastating inflammatory condition of the colon. The incidence of C. difficile infection has risen sharply over the last two decades and today is a leading cause of morbidity and mortality in hospital-acquired infections in the U.S. According to the U.S. Centers for Disease Control and Prevention (CDC), C. difficile is estimated to have caused almost half a million infections in the U.S. in 2011, with 29,000 deaths, often occurring within 30 days of initial diagnosis. Eight out of 10 deaths related to C. difficile infection in the U.S. occur in patients 65 years of age or older, where recurrent infections are common, and estimated treatment cost per infection ranges from $6,000-$9,000.


    John Simard, President and CEO of XBiotech, stated, "This program represents more than the addition of a new anti-infective product to our development pipeline. A successful True Human candidate could be the first oral monoclonal antibody against C. difficile, and a model for an oral antibody therapy approach. Recent outbreaks and increased virulence of C. difficile suggest the urgent need to identify novel approaches to treat the disease. We are eager to bring XBiotech's technology to develop a potential safe and effective therapy for this disease."


    About C. difficile infection


    C. difficile infection occurs most often in patients—such as those in healthcare settings, especially hospitals or nursing homes—who recently took certain antibiotics or other medications. The incidence of C. difficile infection is higher in certain patient populations, including people 65 years of age or older, and in patients with compromised immune systems due to an underlying disease or from treatment. Recurrence is a major challenge in C. difficile infection, with approximately one-in-four patients experiencing a recurrence after the initial episode, and more than 40 percent of these patients having further C. difficile recurrence.


    Current treatments for C. difficile include stopping treatment with the antibiotic-associated infection, if possible, and treatment with one of a limited number of antibiotics that have anti-C. difficile activity. For patients with severe pain, organ failure or inflammation of the lining of the abdominal wall, surgery to remove the diseased portion of the colon may be the only option. The use of monoclonal antibodies against C. difficile toxin has been investigated in animal models and human clinical trials as an alternative to or in combination with traditional antibiotic therapy as treatment for C. difficile infection.

    XBiotech to Provide Third Quarter Business Update

    AUSTIN, Texas, Nov. 5, 2015 (GLOBE NEWSWIRE) -- XBiotech (NASDAQ:XBIT), the world's leading developer of True Human™ therapeutic antibodies, announced today it will host a conference call and live audio webcast on Thursday, November 12, 2015, at 8:30 a.m. ET, to provide an overview of its corporate and clinical activities. The call will encompass developments during the third quarter ended September 30, 2015.


    Conference Call Information:


    Interested participants and investors may access the conference call by dialing:

    • 1 (877) 242-7960 (U.S.)
    • 1 (330) 863-3267 (international)
    • Conference ID: 73120913

    An audio webcast will also be accessible via the Investors Relations section of the XBiotech website www.xbiotech.com/about/investors.html. The webcast replay will remain available for 90 days.

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

    AUSTIN, Texas, Nov. 9, 2015 (GLOBE NEWSWIRE) -- 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."

    XBiotech Identifies Positive Donors for Anti-Clostridium difficile Therapeutic Antibody Only Two Weeks After Initial Screening
    Company to Clone Genes Responsible for Natural Antibody Against C. difficile

    AUSTIN, Texas, Nov. 11, 2015 (GLOBE NEWSWIRE) -- XBiotech (NASDAQ:XBIT), developer of True Human™ therapeutic antibodies, announced today that it has already identified positive donors for its first anti-Clostridium difficile (C. difficile) product candidate. Just two weeks after initial screening of blood donations from healthy volunteers, XBiotech has identified donors that have antibody reactivity against its targeted moieties on the C. difficile bacteria. Identifying natural antibodies against C. difficile in the healthy population is the first step in the discovery process for True Human therapeutic antibodies. Since it is unknown at the onset whether or not natural antibodies will be present in the healthy population, the Company believes that identifying these antibodies, especially so quickly, is a good indication that they are important in protection against disease.


    John Simard, President and CEO of XBiotech, stated, "Once again, we have demonstrated the remarkable efficiency of our True Human platform to identify leads for the development of natural human antibodies against disease. We look forward to now cloning the anti-C. difficile antibody genes, and potentially advancing a lead antibody toward clinical studies. With our C. difficile program we are attempting to do something quite extraordinary—unlike any other marketed antibody therapy, our goal is to develop the first oral-delivered monoclonal antibody therapy. Gut infection with C. difficile is a dreadful disease that attacks the most vulnerable, including the aged and infirm. An oral antibody therapy in this population could be a very important advance. We look forward to achieving further milestones in this program."


    About C. difficile infection


    C. difficile infection occurs most often in patients—such as those in healthcare settings, especially hospitals or nursing homes—who recently took certain antibiotics or other medications. The incidence of C. difficile infection is higher in certain patient populations, including people 65 years of age or older, and in patients with compromised immune systems due to an underlying disease or from treatment. Recurrence is a major challenge in C. difficile infection, with approximately one-in-four patients experiencing a recurrence after the initial episode, and more than 40 percent of these patients having further C. difficile recurrence.


    Current treatments for C. difficile include stopping treatment with the antibiotic-associated infection, if possible, and treatment with one of a limited number of antibiotics that have anti-C. difficile activity. For patients with severe pain, organ failure or inflammation of the lining of the abdominal wall, surgery to remove the diseased portion of the colon may be the only option. The use of monoclonal antibodies against C. difficile toxin has been investigated in animal models and human clinical trials as an alternative to or in combination with traditional antibiotic therapy as treatment for C. difficile infection.

    XBiotech Provides Third Quarter 2015 Corporate and Clinical Update

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

    Recent Highlights:

    • Completed enrollment of Xilonix's Phase 3 European registration study in CRC
    • Reported encouraging data from ongoing S. aureus Phase 1/2 clinical study
    • Received FDA Fast Track designation for anti-S. aureus antibody
    • Published positive Phase 2 results in cardiovascular therapy
    • Enhanced intellectual property protection for True Human™ discovery engine
    • Initiated discovery program in C. difficile
    • Announced positive results for anti-Ebola candidates in collaboration with USAMRIID
    • Identified positive donors for anti-C. difficile antibodies

    AUSTIN, Texas, Nov. 12, 2015 (GLOBE NEWSWIRE) -- XBiotech Inc. (NASDAQ:XBIT), the world's leading developer of next-generation True Human™ therapeutic antibodies, today provided a corporate and clinical update for the third quarter ended September 30, 2015. The Company's CEO and other key members of XBiotech's management team will provide updates on the company's clinical, R&D and manufacturing operations during this morning's conference call and audio webcast today at 8:30 a.m. ET.


    John Simard, the Company's Chief Executive Officer, stated, "XBiotech has taken great strides to advance and build value across our entire business, including our lead clinical programs in oncology and infectious disease. We've also expanded our research and development pipeline and moved closer to significantly enhancing our manufacturing capabilities to support commercial production of our True Human antibody therapies. During the quarter, we completed patient enrollment for our European Phase 3 study of our lead candidate Xilonix™ for treating metastatic colorectal cancer and remain on track to report top line data from the pivotal trial by the end of this year. Additionally, we expanded our XCITE U.S. colorectal cancer study, which continues to ramp up to an anticipated 200 clinical sites across 30 countries worldwide by early next year. We remain on track to complete enrollment in this global FDA study, for which we also received Fast Track designation, by the end of 2016."


    "At an investigators' meeting in October, we announced very encouraging early results from our ongoing Phase 1/2 clinical study of 514G3, an antibody therapy to treat S. aureus infections. The findings provided compelling evidence that 514G3 may enable elimination of S. aureus by the immune system, based on the ability of treated patients' blood to mediate in vitro clearance of S. aureus. We expect to begin enrolling the randomized, blinded Phase 2 stage of the study in February 2016 and complete the study by May 2016. Our program in S. aureus represents a potential franchise XBiotech can build around infectious disease. In addition to S. aureus, we began working to identify novel monoclonal antibodies against Clostridium difficile (C. difficile) using our True Human discovery platform. C. difficile infection can lead to a potentially devastating colitis. We were proud to announce that we successfully identified C. difficile-reactive blood donors just two weeks after beginning our initial screening. Confirmation of anti-C. difficile antibodies in the donor population is the first, crucial milestone in our discovery process. The presence of these antibodies provides the first empirical evidence that C. difficile antibodies exist in healthy individuals, suggesting that these antibodies work to clear C. difficile infection before it can become clinically relevant—thus providing a strong indicator we are on the right track to finding a C. difficile antibody therapeutic.


    Similar to our successful Ebola program, the speed with which we identified donors harboring anti-C. difficile antibodies speaks to our unique ability to generate novel True Human antibodies in the face of urgent medical need. Contingent on donor availability, we can expect to have therapeutic candidates for anti-C. difficile as early as second quarter 2016."


    Mr. Simard continued, "We continue to publish positive results for all of our key clinical programs and this quarter we announced a publication in the Journal of Vascular Surgery highlighting positive results from a Phase 2 study examining Xilonix in patients undergoing procedures to restore peripheral circulation, for which it also has FDA Fast Track designation. These data point towards Xilonix's potential as a safe and effective therapy to preserve vessel patency after endovascular intervention and builds upon the potential for targeting interleukin-1 alpha for a range of sterile inflammatory diseases."


    Mr. Simard concluded, "We are building infrastructure to support future growth in our pipeline and to accommodate commercial-scale manufacturing. We are now nearing completion on a new manufacturing facility, which we expect to begin operations in 2016 and will produce several hundred thousand doses of antibody per year. The construction progress to expand our manufacturing capabilities, strengthened intellectual property surrounding True Human discovery technology, FDA Fast Track designation along with all the significant advances with R&D and clinical programs made for a very positive third quarter."


    Significant Upcoming Milestones

    • Report top-line data for Pivotal European Phase 3 colorectal cancer study by year end 2015
    • Complete construction of new manufacturing facility in March 2016
    • Complete Phase 1/2 study of 514G3 therapeutic antibody against S. aureus by May 2016
    • Complete enrollment and report interim data for global XCITE Phase 3 Xilonix study in late 2016

    Financial Summary


    On April 14, 2015, XBiotech priced its initial public offering of 4,000,000 shares of its common stock at $19.00 per share, for gross proceeds of $76,000,000 before the underwriting discount. The shares began trading on The NASDAQ Global Select Market under the ticker symbol "XBIT" on April 15, 2015.


    As of September 30, 2015, XBiotech had cash and cash equivalents of approximately $105 million. XBiotech continues to have no debt. XBiotech believes their current cash and cash equivalents on-hand will be sufficient to fund operations through calendar year 2017.


    The conference call can be accessed by dialing:

    • U.S. toll free: 877-242-7960
    • International: 330-863-3267
    • Conference ID: 73120913
    • The live audio webcast can be accessed on the Investor Relations section of the XBiotech website at investors.xbiotech.com. The webcast will be archived for 90 days.

    Für diejenigen welche bei XBIT dabei sind, jeden Tag kann kommen:


    "Report top-line data for Pivotal European Phase 3 colorectal cancer study by year end 2015" für Xilonix


    Am Montag gab es einen Sell-Off bis USD 11.31 unter etwas Volumen, am ende war der Kurs jedoch wieder über USD 13.00 und gestern ist der Kurs weiter mit etwas Volumen gestiegen.


    Könne ein kleiner Raid oder ein SL-Fishing gewesen sein ;)

    Xbiotech

    Hoffen wir das positive daten kommen! Was denkst du, falls die studie p3 positiv ist und die ganzen shortseller decken müssen, könnte der kurs hin? Wäre eine übernahme wahrscheinlich? Xbiotech hat meiner meinung nach mit der trueHuman antibody therapie extremes potenzial.

    Yetichris hat am 18.11.2015 - 09:50 folgendes geschrieben:

    Quote

    Hoffen wir das positive daten kommen! Was denkst du, falls die studie p3 positiv ist und die ganzen shortseller decken müssen, könnte der kurs hin? Wäre eine übernahme wahrscheinlich? Xbiotech hat meiner meinung nach mit der trueHuman antibody therapie extremes potenzial.

    Wage keine Prognose aber wenn hier Käufer mit Volumen kommen dann geht es steil nach oben. XBIT war nach IPO schon mit gut einer 1 Mia. bewertet, wenn dies auch zu dem Zeitpunkt sicherlich übertrieben war. Aktuell beträgt die Bewertung ja in etwa 430 Mio. wovon Sie mehr als 100 Mio Cash haben.


    Ja die "trueHuman antibody therapie" hat enormes Potential und der Newsflow ist eigentlich auch sehr positiv...
    Zudem sind mit CEO Simard, Nobelpreisträger Rolf Zinkernagel, Ex-Novartis-Konzernchef Daniel Vasella und der Leiter Dermatologie der Uni-Zürich wirklich fähige Leute dahinter.

    Hoffen wir die Theorie geht auch in der Praxis auf.


    Edit: Short Interest liegt bei ca. 4%
    http://www.nasdaq.com/symbol/xbit/short-interest

    Hmn hier nun die erste "neagtive" News...

    XBiotech Provides Update on Phase III Oncology Study in Europe

    AUSTIN, Texas, Nov. 23, 2015 (GLOBE NEWSWIRE) -- XBiotech (NASDAQ:XBIT), developer of True Human™ therapeutic antibodies, announced today findings related to enrollment in the study. The Company is reporting that data cleaning has revealed a fewer number of per protocol patients available for primary endpoint evaluation. The Company found 25 patients dropped off study prior to receiving any dosing with drug or placebo. Analysis of patient blood samples also revealed that 14 patients erroneously received either placebo or study drug. In addition, 33 patients completed the study but failed to receive scheduled DEXA scans, properly complete EORTC evaluation, or both. The Company reports that these combined irregularities compromises data from 72 patients in the study.


    While the study was oversampled to accommodate loss of patients due to disease progression prior to 8 week evaluation, oversampling was not performed to accommodate data loss as described above. With the loss of an additional patients, the study will have reduced statistical power to demonstrate the proposed effect. All patient samples and data has not yet been received and analyzed by XBiotech. The final number of patients affected is expected to increase or decrease only slightly by the final analysis.


    John Simard, President and CEO of XBiotech, stated, "These findings relating to the execution of the study is disappointing. We anticipate approximately another 10 days to complete ongoing analysis of patient samples and data. At such time, we will provide an update on our findings. These findings will not necessarily delay the scheduled unblinding or final analysis of the data."


    XBiotech has been conducting two separate Phase III studies in colorectal cancer with different study designs under the Food and Drug Administration (FDA) and European Medicines Agency (EMA) regulatory paths, respectively. This update pertains to the European study, which was developed in collaboration with the EMA. The novel study design is a double-blind, placebo-controlled study that randomizes patients (2:1) to receive Xilonix plus best supportive care, or placebo plus best supportive care. The co-primary endpoints being assessed are change in lean body mass and change in patient reported symptoms from baseline to the 8 week follow up. Improvements in lean body mass are measured using a form of X-ray imaging called DEXA, combined with an assessment of patient well-being with respect to pain, fatigue and/or appetite loss. Specifically, stabilization or a gain in lean body mass at the 8-week follow up combined with improvement or no worsening in two of the latter measures of patient well-being, as measured by the validated EORTC QLQ-C30 questionnaire, enable a patient to be considered a responder for the purposes of the primary endpoint. The co-primary endpoints were designed to capture important surrogates for anti-cancer treatment effect, especially those that have been found in the past to correlate independently with improved overall survival. After completing assessment of the primary endpoint at eight weeks, patients are eligible to cross over into an open label extension of Xilonix.


    The Company's second colorectal cancer study is a global Phase 3 study being conducted under a Fast Track designation from the FDA. This study is randomized 2:1 with patients receiving Xilonix or placebo plus best supportive care. Patients are required to have metastatic colorectal cancer, and have failed regimens including flouropyrimidines, oxaliplatin, and irinotecan. Unlike the EMA trial, symptoms at baseline are not required for entry. Patients continue on study until there is evidence of radiographic progression. The primary endpoint of this study is overall survival, with secondary endpoints of objective response rate, progression free survival, change in lean body mass as measured by DEXA, and improvement in patient reported quality of life using the validated EORTC QLQ C30 questionnaire.


    http://investors.xbiotech.com/…ol-newsArticle&ID=2116955


    After Hours unter kaum Volumen:
    XBIT $9 (-4.25) -32.08%

    Konsequenzen

    Hallo aurum,


    ich kenn mich echt zu wenig mit biotech aus, resp muss noch viel dazu lernen.


    was bedeutet das jetzt für xilonix? Deine einschätzung? Und, ist das nicht normal das gewisse patienten ausscheiden? Sonst wäre ja der begriff per protocol analyse nicht erfunden worden. Oder ist da die annahme, das es nichts nützt, da so viele ausgestiegen sind?


    Besten dank im voraus.

    Yetichris hat am 24.11.2015 - 10:54 folgendes geschrieben:

    Ich kann dir noch keine Antwort geben.


    Fakt ist jedoch, XBIT hat einiges Vertrauen verspielt... Die Studie ist zwar nicht gefloppt aber sehr wahrscheinlich, dass Sie diese nochmals durchführen müssen. Dieses Durcheinander der Daten ist nicht gerade vertrauenswürdig...


    Ich glaube ich habe gelesen, dass die Kosten für die EU-Studie zwar "nur" 9 Mio waren aber das wird heute keine Rolle spielen wenn der Kurs gehämmert wird... Kurse unter 10 werden heute Realität werden.


    Der Flashcrash von vor einer Woche hätte eine Warnung sein sollen...