XBiotech

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Hans
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XBiotech

IPO erfolgt, an der Nasdaq gelistet. D. Vasella im VR 

http://www.nasdaq.com/press-release/xbiotech-closes-initial-public-offering-20150417-00510

http://www.handelszeitung.ch/news/daniel-vasella-wird-verwaltungsrat-bei-us-jungunternehmen-xbiotech

Daniel Vasella wird Verwaltungsrat bei US-Jungunternehmen XBiotech

Zürich (awp) - Der ehemalige Novartis-Chef Daniel Vasella engagiert sich beim US-Start-up XBiotech. Vasella werde neuer Verwaltungsrat des US-Unternehmens mit Sitz in Austin/Texas, schreibt der "Tages-Anzeiger" (Ausgabe 05.11.). Für das Jungunternehmen seien unter anderen bereits Nobelpreisträger und Ex-Novartis-Verwaltungsrat Rolf Zinkernagel sowie Thomas Kündig, ein Forschungsleiter am Unispital Zürich, seit Jahren im Hintergrund tätig.

Vasella erhalte für sein Mandat wie alle VR-Mitglieder jedes Jahr Optionen von XBiotech. Das Unternehmen wolle noch vor Jahresende an die Börse gehen, heisst es weiter. Das Unternehmen soll mit dem Börsengang 100 Mio USD am Markt aufnehmen wollen.

XBiotech ist in den Bereichen Onkologie, Therapie von Antibiotika-resistenten Erregern, Herz-Kreislauferkrankungen, Dermatologie und Diabetes Typ 2 aktiv, wie der Webseite des Unternehmens zu entnehmen ist. Derzeit werden Patienten für zwei Phase-III-Studie mit dem Prüfmedikament Xilonix zur Behandlung von Kolorektalkrebs sowie für Phase-II-Tests mit RA-18C3 zur Therapie der schweren Hauterkrankung Pyoderma Gangrenosum (Dermatitis ulcerosa) rekrutiert. Der Ansatz des Unternehmens basiert dabei auf menschlichen Antikörpern, die aus der Reaktion des menschlichen Immunsystems stammen.

 

Aurum
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Spannender Tipp - Danke!

IPO war USD 19.00, jetzt bereits Pre Market über USD 28.00 und somit gegen 900Mio MK.

Haben aber ne nette Pipeline:
http://www.xbiotech.com/clinical/index.html

Verfolge die Firma mal und ev. Einstieg nach Abkühlung des Kurses.

Aurum
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Gesten +20%, heute im Pre aktuell 6% auf USD 31.50.

Samit wäre XBiotech bereits mit 1 Mia. bewertet.

Aurum
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Heute unter 23 eine Position aufgebaut.

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@Aurum

Gratuliere! Ich war am Freitag mit 26 einen Tick zu früh dran... aber ich werde hier sowieso in Tranchen einsteigen.

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1mia mkap !?

btw;

Thomas Gut

UFC Ltd. Family Office

Selnaustrasse 5

8001 Zurich, Switzerland

 

 

Ownership.

As of April 17, 2015:

 

  Angel Amount Beneficially Owned:

2,318,583 shares.

 

  (b) Percent of Class:

7.31%. Based upon 31,716,631 shares of common stock outstanding at April 17, 2015.

 

 

 

----gesperrt wegen gutmenschentum, wünsche an der stelle allen alles gute, wie immer. http://investorshub.advfn.com/boards/profilea.aspx?user=193864

Aurum
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@b00n

MK aktuell rund 700Mio. - stattlich aber denke gerechtfertigt bei der Pipeline:
http://www.xbiotech.com/clinical/index.html

Kursrange 21.67 - 32.50 an 8 Handelstagen zeit IPO ist auch nichts für schwache Nerven Wink

Aurum
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Heute wären es noch bessere Kurse zum kaufen gewesen Wink

Aurum
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Nochmals nachgelegt.

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05.18.15 - XBiotech Secures Approval from Data Safety Monitoring Board to Continue Phase 3 Registration Study in Europe for its Novel Cancer Immunotherapy

XBiotech (NASDAQ: XBIT), developer of Xilonix anti-cancer therapy for the treatment of colorectal cancer, announced today that the Data Safety Monitoring Board (DSMB) has recommended continuation of the Company’s Phase 3 registration study underway in Europe. The study, launched in March of 2014, is on schedule for completion this year. The DSMB decision follows a pre-scheduled interim review as part of the study plan. The DSMB board consists of an independent panel of medical experts that oversee execution of the study. While a DSMB’s primary responsibilities are related to safety, they also generally evaluate study conduct with respect to good clinical practices and make recommendations concerning continuation, modification or termination of the trial.

As part of the only planned DSMB review, the group was tasked with assessing what fraction of patients enrolled had completed all endpoints. Normally, not all patients enrolled make it through all the data endpoints. Based on these findings, the DSMB was to make a recommendation for increasing the patient sample size to maintain statistical power of the study. The DSMB made a recommendation for sample size increase that was within expectations and the Company states enrollment remains on pace to meet the completion timelines.

The primary objective of the double-blinded, placebo-controlled, multi-center study is to assess the effectiveness of Xilonix for treating patients with symptomatic colorectal cancer. Xilonix blocks interleukin-1 alpha (IL-1a), an inflammatory mediator that acts at the site of the tumor to stimulate growth of tumor blood supply and support tumor growth. In addition, IL-1a may aid circulating tumor cells to form new sites of metastasis and also be involved as a messenger in the brain, where it can trigger fatigue, anxiety and metabolic dysregulation seen in advanced cancer. In a previous study at MD Anderson, Xilonix therapy appeared to not only have anti-tumor effects and prolong survival, but also seemed to improve symptoms of muscle loss, fatigue, appetite loss, and pain in patients with advanced cancer.

In the current study, anti-tumor effect will be measured by assessing the change in these symptoms for patients treated with Xilonix versus those treated with placebo. Reversal of muscle loss will be assessed with a novel type of radiology called dual energy X-ray absorptiometry, or DEXA. Improvement in pain, appetite loss, and fatigue will be measured with a well-established and validated questionnaire that reliably assesses patient well being as reported by patients themselves.

John Simard, President and CEO of XBiotech, commented, “The DSMB recommendation is indeed an important milestone for our lead oncology therapy. While the DSMB outcome confirms Xilonix’s extraordinary safety profile, this result also demonstrates that our study is being well-executed and proceeding according to plan. We are all looking forward to unblinding this remarkable study later this year.”

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XBiotech Successfully Clones First Anti-Ebola Therapeutic Antibody Product Candidate

AUSTIN, Texas, May 26, 2015 (GLOBE NEWSWIRE) -- XBiotech (XBIT), the developer of True Human(TM) therapeutic antibodies, announced today that it has successfully isolated and cloned an anti-Ebola product candidate using its True Human antibody discovery platform.

True Human antibodies are derived directly from human donors that have natural immunity to disease. The anti-Ebola product candidate was developed from a blood donation received earlier this year from a patient who recovered from Ebola infection.

John Simard, President and CEO of XBiotech, stated, "Our response to the Ebola outbreak has been a very special project in several ways. Our technology offered us the ability to develop a curative therapy to a deadly disease that was ravaging nations and even threatened us here at home; and it offered the potential to develop a therapy with unparalleled speed. What started with selfless donations from Ebola survivors only a few months ago has resulted in a True Human antibody therapeutic candidate that could be used to treat the disease. We are very proud of the capabilities we have developed and are humbled by the potential to address serious unmet medical need at home and abroad."

Simard continued, "Additionally, the results of our Ebola program further represent how XBiotech's core strength in efficient drug discovery makes the company uniquely capable to quickly respond to disease outbreaks."

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Fulminanter Start und würde mich nicht wundern, falls der noch ins minus dreht………sind doch gute Nachrichten?

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Sole69 hat am 27.05.2015 - 16:17 folgendes geschrieben:

Fulminanter Start und würde mich nicht wundern, falls der noch ins minus dreht………sind doch gute Nachrichten?

Definitiv gute Nachrichten - Da jedoch momentan keine Ebola Panik herrscht verpufft diese wieder oder das GAP wird noch schnell geschlossen. Mal schauen Smile

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Siehst du da schon noch ein grosses Potenzial bei dieser Aktie?

 

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Sole69 hat am 27.05.2015 - 16:39 folgendes geschrieben:

Siehst du da schon noch ein grosses Potenzial bei dieser Aktie?

 

Ja definitiv - XBIT ist meine grösste Position.

Schau mal die Pipeline (spannende Indikationen) an und die True Human Antibodies Plattform / Technologie.

Denke viele haben XBIT noch nicht auf dem Radar... Seit Montag ist zumindest die "quiet-period" zu Ende!

Bin gespannt auf KZ der Analysten.

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Bin auch gespannt, wie die Analysten die Aktien Bewerten und was für Kursziele sie nennen…….mal schauen.

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XBiotech Launching Phase 1/2 Clinical Study of Novel True Human(TM) Therapeutic Antibody for Treating Serious Infections Due to Staphylococcus Aureus

AUSTIN, Texas, May 28, 2015 (GLOBE NEWSWIRE) -- XBiotech Inc. (XBIT), a leading developer of next-generation True Human(TM) therapeutic antibodies, announced today that the Food and Drug Administration (FDA) has lifted its clinical hold from the Company's IND, enabling launch of its therapy for S. aureus infections. XBiotech was placed on clinical hold while it worked with the agency to prepare its novel therapy and manufacturing process for human studies. XBiotech will now begin enrollment of approximately 52 patients in a Phase 1/2 randomized, placebo-controlled, dose escalation study, which will evaluate safety and efficacy of the therapy to treat serious S. aureus infections.

This drug candidate was developed using XBiotech's True Human antibody discovery platform, which involves screening healthy individuals to identify those with natural immunity to specific diseases. The therapy was derived from an individual that harbored natural antibodies capable of neutralizing S. aureus, including drug-resistant strains of the disease. The treatment is being developed to treat all forms of staph infections and will first be tested in patients with life-threatening infections that are present in the blood, known as bacteremia. The antibody is capable of blocking the key mechanism that S. aureus uses to evade the body's immune system. The therapy can thus at once undermine the bacteria's escape mechanism and facilitate its natural clearance by the body's immune system.

John Simard, the Company's Chief Executive Officer said, "We are grateful to the FDA for working very closely with us to launch the first of our new infectious disease therapies. It would be difficult to overstate the potential impact this new therapy could have on how therapies are developed and used to treat infections. Derived from natural immunity, this true human antibody offers the means to provide safer, more effective treatments that are not susceptible to present forms of drug resistance. Our antibody therapy represents what we foresee as the launch of '21st century antibiotics,' and the coming of age of biotechnology in the area of infectious disease."

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Bei diesen Kursschwankungen, versteht man nicht ob das gute oder schlechte News sind?

Wahnsinnig die Kursdifferenzen in einem Tag.

 

Gestern eine Preisspanne von 20 – 22.92

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Sole69 hat am 28.05.2015 - 15:43 folgendes geschrieben:

Bei diesen Kursschwankungen, versteht man nicht ob das gute oder schlechte News sind?

Wahnsinnig die Kursdifferenzen in einem Tag.

 

Gestern eine Preisspanne von 20 – 22.92

Ja solche Schwankungen sind an sich nichts speziellen bei Biotechs aber es erstaunt mich schon, dass nach zwei positiven PE wir tiefer stehen. Naja ich sehe XBIT als sehr LONG an.

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XBiotech Announces Publication of Phase 2 Clinical Results for Its True Human(TM) Antibody MABp1 for Treating Acne Vulgaris Monotherapy Led to Rapid Improvement in Skin Lesions and Acne-Associated Psychological Symptoms

AUSTIN, Texas, June 15, 2015 (GLOBE NEWSWIRE) -- XBiotech (Nasdaq:XBIT), the developer of True Human™ therapeutic antibodies, announces positive results from the Company's Phase 2 study of its MABp1 antibody for treating acne vulgaris. Findings are published in the June 2015 issue of Journal of Drugs in Dermatology1. The study concluded that MABp1, due to its unique molecular target, may be a safe and effective means of treating not only inflammatory acne lesions, but also improving feelings of depression and anxiety commonly associated with acne.

MABp1 is a novel True Human monoclonal antibody that neutralizes interleukin-1 alpha (IL-1α), a potent inflammatory substance naturally produced by the body in minute quantities but which can cause disease when not effectively controlled. Previous studies suggest that IL-1α plays a role in the early stages of acne lesion formation, so the effect of IL-1α blockade with MABp1 on reducing lesion count was assessed. Furthermore, IL-1α signaling in the hypothalamus region of the brain is also known to mediate triggering feelings of anxiety and depression, which are commonly reported by acne patients, suggesting a second potential point of intervention that is unique to MABp1.

Dr. Michael Stecher, author and Medical Director for XBiotech, said, "The initial response demonstrated in this trial suggests that the novel mechanism of IL-1α blockade may represent a promising new strategy in the treatment of moderate to severe acne. Interestingly, it is the first clinical study to demonstrate a compelling mechanistic link between the physical and mental symptoms of the disease by showing both could be improved by IL-1α inhibition. It may indeed be the first agent that could potentially treat both skin lesions as well as the psychiatric manifestations of this disorder. Further studies using this antibody are warranted in this patient population."

John Simard, President and CEO of XBiotech, added, "We are very pleased to publish the data from our Phase 2 study of MABp1 in this journal. Not only does it serve to highlight our potential breakthrough therapy for treating acne, it also showcases the remarkably broad applicability of our MABp1 True Human antibody, for which we have shown significant potential to treat the key inflammatory processes that play a role in exacerbation or progression of a wide range of diseases, including colorectal cancer, non-small cell lung cancer, type-2 diabetes and other dermatological indications such as psoriasis and pyoderma gangrenosum."

In the open-label Phase 2 clinical study, ten patients with moderate to severe acne received three subcutaneous injections of MABp1 monotherapy over a six-week period and were followed for a total of 70 days to assess safety and efficacy endpoints. MABp1 showed excellent tolerability in the study, with no serious adverse events reported and only few mild adverse events. Disease severity, as measured by inflammatory lesion count, improved consistently, with a median 36% reduction by day 56. MABp1 monotherapy also resulted in clinically meaningful improvements in anxiety/depression and body image scores using two clinically validated questionnaires (Hospital Anxiety and Depression Scale (HADS), median score of 6 reduced to 1 on day 56; and Body Image Disturbance Questionnaire (BIDQ), mean overall score improved from 2.3+.09 to 2.1+.01).

1Carrasco et al., "An Open Label Phase 2 Study of MABp1 Monotherapy for the Treatment of Acne Vulgaris and Psychiatric Comorbidity." J Drugs Dermatol. June 2015;14(6):560-564. The Journal of Drugs in Dermatology is a peer-reviewed publication offering original articles, award-winning case reports, and timely features pertaining to new methods, techniques, and drug therapy in dermatology.

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CORRECTING and REPLACING -- XBiotech Announces Publication of Phase 2 Clinical Results for Its True Human(TM) Antibody MABp1 for Treating Acne Vulgaris Monotherapy Led to Rapid Improvement in Skin Lesions and Acne-Associated Psychological Symptoms

AUSTIN, Texas, June 15, 2015 (GLOBE NEWSWIRE) -- In a release issued under the same headline earlier today by XBiotech (Nasdaq:XBIT), please note that in the fifth paragraph the mean overall scores of .09 and .01 should be 0.9 and 0.1. The corrected release follows.

XBiotech (Nasdaq:XBIT), the developer of True Human™ therapeutic antibodies, announces positive results from the Company's Phase 2 study of its MABp1 antibody for treating acne vulgaris. Findings are published in the June 2015 issue of Journal of Drugs in Dermatology1. The study concluded that MABp1, due to its unique molecular target, may be a safe and effective means of treating not only inflammatory acne lesions, but also improving feelings of depression and anxiety commonly associated with acne.

MABp1 is a novel True Human monoclonal antibody that neutralizes interleukin-1 alpha (IL-1α), a potent inflammatory substance naturally produced by the body in minute quantities but which can cause disease when not effectively controlled. Previous studies suggest that IL-1α plays a role in the early stages of acne lesion formation, so the effect of IL-1α blockade with MABp1 on reducing lesion count was assessed. Furthermore, IL-1α signaling in the hypothalamus region of the brain is also known to mediate triggering feelings of anxiety and depression, which are commonly reported by acne patients, suggesting a second potential point of intervention that is unique to MABp1.

Dr. Michael Stecher, author and Medical Director for XBiotech, said, "The initial response demonstrated in this trial suggests that the novel mechanism of IL-1α blockade may represent a promising new strategy in the treatment of moderate to severe acne. Interestingly, it is the first clinical study to demonstrate a compelling mechanistic link between the physical and mental symptoms of the disease by showing both could be improved by IL-1α inhibition. It may indeed be the first agent that could potentially treat both skin lesions as well as the psychiatric manifestations of this disorder. Further studies using this antibody are warranted in this patient population."

John Simard, President and CEO of XBiotech, added, "We are very pleased to publish the data from our Phase 2 study of MABp1 in this journal. Not only does it serve to highlight our potential breakthrough therapy for treating acne, it also showcases the remarkably broad applicability of our MABp1 True Human antibody, for which we have shown significant potential to treat the key inflammatory processes that play a role in exacerbation or progression of a wide range of diseases, including colorectal cancer, non-small cell lung cancer, type-2 diabetes and other dermatological indications such as psoriasis and pyoderma gangrenosum."

In the open-label Phase 2 clinical study, ten patients with moderate to severe acne received three subcutaneous injections of MABp1 monotherapy over a six-week period and were followed for a total of 70 days to assess safety and efficacy endpoints. MABp1 showed excellent tolerability in the study, with no serious adverse events reported and only few mild adverse events. Disease severity, as measured by inflammatory lesion count, improved consistently, with a median 36% reduction by day 56. MABp1 monotherapy also resulted in clinically meaningful improvements in anxiety/depression and body image scores using two clinically validated questionnaires (Hospital Anxiety and Depression Scale (HADS), median score of 6 reduced to 1 on day 56; and Body Image Disturbance Questionnaire (BIDQ), mean overall score improved from 2.3+0.9 to 2.1+0.1).

1Carrasco et al., "An Open Label Phase 2 Study of MABp1 Monotherapy for the Treatment of Acne Vulgaris and Psychiatric Comorbidity." J Drugs Dermatol. June 2015;14(6):560-564. The Journal of Drugs in Dermatology is a peer-reviewed publication offering original articles, award-winning case reports, and timely features pertaining to new methods, techniques, and drug therapy in dermatology.

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NBI gestern mit knapp +3% satt gelaufen auf neues ATH und XBIT ist nach anfänglichem +5% Start mit -2.64% aus dem Handel gegangen.

Dies verwundert mich nach dem positiven Newsflow doch sehr... Auch bedenkenswert ist, dass die WS bzw. die Analysten den Titel nicht mit Ratings abdecken...

Meinungen?

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Bei XBIT endete die quiet-period ja erst am 25.05. - ich denke das dauert einfach noch eine Weile bis sich die Analysten eingehend damit befasst haben. Ich könnte mir zudem vorstellen, dass XBIT selbst noch etwas zurückhaltend ist mit Aussagen und Prognosen - was mir eigentlich gefällt. XBIT hat m.E. ein riesiges Potential (muss dann natürlich jedoch auch ausgeschöpft werden können).

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XBiotech Added to Russell 2000 Index

AUSTIN, Texas, June 24, 2015 (GLOBE NEWSWIRE) -- XBiotech Inc., (Nasdaq:XBIT), the developer of True HumanTM therapeutic antibodies, announced today that the Company has been added to the Russell 2000 Index, Russell 3000 Index, Russell Global Index, and Russell Microcap Index as part of Russell Investments' annual index rebalance on June 29, 2015. A preliminary list of companies in the Microcap and other indices can be found at www.russell.com/indexes.

John Simard, CEO of XBiotech, stated, "XBiotech's addition to the Russell 2000 Index is a gratifying milestone for the company following our successful IPO. Inclusion in the Index should serve to increase our exposure among investors and add value for our shareholders. Our mission to discover and deliver new antibody therapies based on natural immunity to disease is nothing short of a paradigm shift in medicine, while our dramatic cost reduction of the manufacturing process is setting new expectations for the cost of drug development. We have received strong support from the investment community to date and inclusion in the Russell Index offers further objective measure of the investment opportunity."

Russell Investments reconstitutes its indices annually, determining membership for its equity indexes primarily by objective, rules-based market-capitalization rankings and style attributes. Membership in the Russell 2000, which remains in place for one year, is based on membership in the broad-market Russell 3000 Index. Membership in the Russell Indexes means automatic inclusion in the appropriate growth and value style indexes.

The Indexes are widely used by investment managers and institutional investors for index funds and as benchmarks for both passive and active investment strategies. Russell calculates more than 700,000 benchmarks daily, covering approximately 98% of the investment market globally, 80 countries, and more than 10,000 securities. Approximately $5.7 trillion in assets are benchmarked to Russell Indices.

About FTSE Russell:

Russell Indexes is part of FTSE Russell, a leading global index provider. Institutional and retail investors use FTSE Russell index expertise and products extensively. Leading asset owners, asset managers, ETF providers and investment banks use FTSE Russell indexes to benchmark their investment performance and create ETFs, structured products and index-based derivatives.

A core set of universal principles guides FTSE Russell index design and management: independent committees of leading market participants inform a transparent rules-based methodology. FTSE Russell is focused on applying the highest industry standards in index design and governance. FTSE Russell is also focused on index innovation and client collaboration as it seeks to enhance the breadth, depth and reach of its offering.

FTSE Russell is wholly owned by London Stock Exchange Group. For more information, visit www.ftserussell.com

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echt erstaunlich wie dieser Titel zwischen dem Range 18 -22$ rumdümpelt.

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2brix hat am 24.06.2015 - 19:11 folgendes geschrieben:

echt erstaunlich wie dieser Titel zwischen dem Range 18 -22$ rumdümpelt.

so jetzt sind wir wieder bei unter 18$. Wann kommen mal Kursziele?

52 week 17.06 - 32.50

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Die 18 konnten noch knapp gehalten werden aber wieder nach positiven Handelsbeginn (19.79) und
starken NBI (+2.2%) im Minus geschossen...

Nicht ganz nachvollziehbar, zumal XBIT einen guten, positiven Newsflow in letzter Zeit hatte.
http://investors.xbiotech.com/phoenix.zhtml?c=253990&p=irol-news&nyo=0

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XBiotech Conducts Investigators Meeting to Update the Status of Its Phase III Registration Study Underway in Europe
 

AUSTIN, Texas, July 1, 2015 (GLOBE NEWSWIRE) -- XBiotech (XBIT), the developer of True Human(TM) therapeutic antibodies, announced today that it held an investigators meeting to update clinicians and support staff on the overall status of the Company's Phase III study in colorectal cancer. The Company is conducting a double-blinded, placebo-controlled registration study of its anticancer agent for the treatment of advanced colorectal cancer. The novel anti-cancer agent, Xilonix(TM), is being developed with a regulatory path that the Company established in collaboration with the scientific advisory committee of the EMA.

The potential breakthrough cancer drug is being evaluated under the EMA's "Guideline on Evaluation of Anticancer Medicinal Products in Man," which offers the possibility to establish novel approval endpoints for anti-cancer agents. In advanced cancer, historically only modest tumor responses are seen in a small percentage of the population. The EMA is thus seeking new endpoints and novel agents that will enable the evaluation of anti-tumor therapy based on patient recovery. Thus the EMA has proposed in its guidelines that, "In patients with tumour-related symptoms at baseline, symptom control, if related to anti-tumour effects, is a valid measure of therapeutic activity and may serve as primary endpoints in late line therapy studies."

The Company's Xilonix therapeutic monoclonal antibody targets the molecular signalling that leads to neoangiogenesis and other processes that support tumor vascularization and growth. However, the same molecular target is known to signal the brain to cause pain, fatigue, anxiety, appetite suppression and hypermetabolic syndrome seen in advanced cancer. Earlier observations of physical recovery that strongly correlated with improved overall survival were unprecedented findings with Xilonix therapy in advanced cancer patients. The results were published in April 2014 in Lancet Oncology. These findings positioned Xilonix to be able to take advantage of the EMA's unique regulatory pathway for anti-cancer drug development.

The data presented today to investigators summarized the major findings to date. Although the study was not unblinded and only aggregate data were presented, physicians and support staff involved in the study were given an opportunity to gain a better sense of the overall patient performance. The Company explained that the unprecedented nature of the study design means that physicians have little or no idea of what the overall expectations should be for study participants. The Company is providing the blinded data as requested so that physicians and other care givers may be better able to provide patients with expectations for overall outcomes, so that patients may be better informed when deciding whether to participate in this study.

The following data were presented:

A total of 220 patients were reported to be currently enrolled in the study. Data were provided relating to patient performance in the study. As of June 15, 2015, the company stated that 183 patients had completed at least one cycle of therapy and 98 patients had baseline and follow-up DEXA and EORTC-QLQc30 data available. It was also reported that 35 patients had dropped out before completing the 8-week treatment regimen, while there were a further 50 patients at various stages of the 8 week treatment regimen. The Company reported that 61 patients (62% of evaluable patients) were considered to have a positive DEXA outcome as defined for the responder endpoint, with an average LBM change of 2.1 +/- 2.8 kg (median 1.2 [IQR 0.5 to 2.0] kg). At the time of analysis, there were also 59 patient responders (60% of evaluable patients) according to the EORTC responder definition. There were 93 patients evaluable for RECIST, which included 2 partial responses (PR) and 23 patients with stable disease (SD). The study was also said to be on schedule for completion as planned this year.

DEXA, or dual-energy X-ray absorptiometry, is a type of X-ray machine that can measure body compartments, and distinguish between bone, fat and lean tissue (i.e. muscle). The DEXA can thus be used to measure non-fat weight gain in patients. EORTC-QLQ30 is a validated questionnaire developed in Europe that is used to accurately record patient reported health status, such as levels of fatigue, pain and appetite. A DEXA and EORTC performance composite was used to identify patient response to therapy. To be a responder individual patients must meet both DEXA and EORTC response criteria. The study has been designed to compare responders in the treatment arm versus the placebo.

John Simard, XBiotech's CEO, stated, "The observation of recovery in advanced cancer patients treated with Xilonix made it an ideal therapy for us to work with the EMA to pioneer new endpoints for evaluating cancer therapy in advanced disease. It is widely recognized that in the presence of uncontrolled disease, symptom recovery cannot be anticipated. So the EMA's concept to develop cancer therapies around symptom recovery guides us towards developing anticancer agents that are better for the patient. I think this is tremendously insightful and a definite positive force for creating new and better therapies that keep the well being of cancer patients in mind. To date, however, due to toxicities of most agents, few anti-cancer therapies have been demonstrated to facilitate symptom recovery in a controlled study. Xilonix is thus at the crossroads of being a truly breakthrough anti-cancer agent that helps cancer patients feel better while treating their tumors, while Xilonix also sets a historic precedence for the way cancer therapies are conceived and evaluated in the clinic."

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ich kann nicht wirklich was beitragen, aber ich versehe echt nicht, wieso xbit immer im minus ist.

17.23 -1.41 (-7.56%)  Klar ist der Markt momentan negativ, aber hier stimmt doch was nicht. Wissen da einige was mehr?

 

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XBIT
XBiotech begins phase 1/2 study of new True Human therapeutic antibody to treat Staphylococcus aureus infections
Austin, Texas
Wednesday, July 08, 2015, 17:00 Hrs  [IST]
 

XBiotech Inc., world's leading developer of next-generation True Human therapeutic antibodies, announced treatment of first patient in its phase 1/2 clinical study. The study is designed to evaluate dosing, safety and efficacy of a novel antibody therapy intended to treat all forms of Staphylococcus aureus infections, including Methicillin-resistant S. aureus (MRSA).

The company reports that the first patient to enter the study had confirmed MRSA bacteremia that was life threatening. Within 24 hours of receiving a single, low dose of the therapy, the patient had no fever and white blood cell counts began to normalize. These observations suggested rapid control of the infection was achieved upon administration of the antibody. The study is expected to be completed by Q1 2016.

XBiotech's therapy, known as 514G3, was developed from a human donor with natural antibodies effective at neutralizing MRSA and non-MRSA forms of S. aureus. 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, the company also expects 514G3 to be tolerated without the side effects or risks of antibiotics.

John Simard, the company's chief executive officer, said, "The ability to treat lethal drug-resistant bacterial infections with a therapy isolated from a human being with natural immunity to the disease is simply a breakthrough approach to creating new medicines. I am thrilled beyond words that our therapy may have helped a patient overcome this dreadful and deadly infection. Our entire team at XBiotech will bring the utmost urgency to providing this therapy to as many patients in as many centers as possible."

Simard continued, "Entering clinical development with a second True Human therapeutic is a significant achievement for XBiotech. We have been showing the potential for human antibody therapy for the treatment of cancer and other chronic disease conditions. Now with the launch of our first therapy for infectious disease, I think the scope of human-derived antibody therapies really begins to emerge. With our continued success in the clinic, we are set to redefine how drugs are developed and used to treat a range of critical human diseases."

MRSA is a major disease problem worldwide (Grundmann et al. Lancet, 2006). When the infection enters the blood (called bacteremia) it is associated with severe morbidity and can quickly become lethal. In addition to methicillin, MRSA have acquired resistance to antibiotics that include erythromycin, clindamycin, ciprofloxacin and tetracycline among others. In 2009, in the U.S. there were an estimated 697,248 hospitalizations related to S. aureus infections (Klein et al. American Journal of Epidemiology, 2012), while between 1999 and 2005 the cases of hospitalizations due to MRSA more than doubled. Between 2009 and 2010 there were 236,000 cases of MRSA infections related to surgical procedures alone in the U.S. Recent reports from the CDC suggest that the alarming rate of increase in MRSA infections appears to have begun to stabilize in the U.S., but the threat of MRSA remains and the emergence of more aggressive strains continues to be a serious worldwide problem.

The randomized, placebo-controlled, dose escalation study will enroll 52 patients at approximately 16 clinical sites in the United States, Europe and Southeast Asia. Hospitalized patients with S. aureus bacteremia will be randomized to receive 514G3 plus standard of care antibiotics or placebo plus antibiotics. The study will be unblinded during the phase 1 dose escalation stage, where the maximum tolerated dose will be determined, followed by a phase 2 study designed to assess efficacy against S. aureus infection. The primary efficacy endpoint is time to clearance of bacteremia, as measured by blood culture. The study will also evaluate pharmacokinetic parameters as well as duration of fever and length of hospitalization as secondary endpoints.

XBiotech is pioneering a new era in the discovery and development of targeted antibodies based on its True Human technology.

 

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