XBiotech Announces First Patient in Phase 2 Study Evaluating Subcutaneous MABp1 in Patients with Hidradenitis Suppurativa
AUSTIN, Texas, July 10, 2018 (GLOBE NEWSWIRE) -- XBiotech Inc. (NASDAQ:XBIT) announced today that the first patient has been enrolled in its Phase 2 open label, dose escalation clinical study evaluating the Company's subcutaneous formulation of MABp1 in patients with moderate to severe Hidradenitis Suppurativa (HS). The patient began treatment at Tennessee Clinical Research Center located in Nashville under the care of Dr. Michael Gold.
Dr. Gold commented, "We are very excited to be participating with XBiotech in this ground breaking research endeavor for patients suffering from hidradenitis suppurativa. We are hopeful that this research will unlock some of the important keys to successfully treating our patients."
XBiotech is developing a human-derived antibody (MABp1) which neutralizes IL-1 alpha (IL-1a), an inflammatory cytokine that plays a key role in the pathophysiology of a wide range of inflammatory skin disorders1. Three phase II studies sponsored by XBiotech have been completed in dermatologic indications (acne, psoriasis, pyoderma gangrenosum) 2,3. Results from an investigator sponsored phase 2 study evaluating MABp1 for the treatment of Hidradenitis Suppurativa were published in the Journal of Investigative Dermatology with the study meeting its primary endpoint, demonstrating significant improvement of HS patients treated with MABp1 compared to control after 12 weeks of therapy (response rate of 60% vs 10%, respectively (p=0.035)) 4,. This previous HS study, however, involved intravenous infusion of the antibody therapy. This will be the first use of the MABp1 subcutaneous formulation in HS, including the use of pre-filled syringes with a newly developed concentrated formulation of MABp1 for convenient dosing.
For more information on this study, please visit www.clinicaltrials.gov
About Hidradenitis Suppurativa
Hidradenitis Suppurativa (HS) is a chronic, inflammatory skin disorder affecting areas rich in apocrine glands. Nodules appear in the affected areas and progressively become swollen with spontaneous rupture and release of pus. This process occurs repeatedly leading to formation of deep sinus tracts and painful dermal abscesses5,6. Therefore, HS is often devastating for patients with significant impact on quality of life 7. The Dermatology Quality Life Index (DQLI) for HS is 8.9, being higher than any other skin disorder8. Traditional treatments comprise of antibiotics, antiandrogens and surgery. The global prevalence for HS is estimated at up to 4% of the population 2.
XBiotech is a fully integrated, global biopharmaceutical company dedicated to pioneering the discovery, development and commercialization of therapeutic antibodies. XBiotech currently is advancing a pipeline of therapies based on harnessing naturally occurring antibodies from patients with immunity to certain diseases. The approach to use natural human immunity as a source of new medicines offers the potential to redefine the standards of care a wide range of diseases. Headquartered in Austin, Texas, XBiotech also is leading the development of innovative manufacturing technology to reduce the cost and complexity of biological drug production. For more information, visit www.xbiotech.com.
Cautionary Note on Forward-Looking Statements
This press release 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 the "Risk Factors" section of certain of our SEC filings. Forward-looking statements are not guarantees of future performance, and our actual results of operations, financial condition and liquidity, and the development of the industry in which we operate, may differ materially from the forward-looking statements contained in this press release. Any forward-looking statements that we make in this press release speak only as of the date of this press release. We assume no obligation to update our forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press release.
1 Bou-Dargham MJ et al. The Role of Interleukin-1 in Inflammatory and Malignant Human Skin Diseases and the Rationale for Targeting Interleukin-1 Alpha. Med Res Rev. 2017 Jan;37(1):180-216.
2 Coleman KM et al. Open-Label Trial of MABp1, a True Human Monoclonal Antibody Targeting Interleukin 1a, for the Treatment of Psoriasis. JAMA Dermatol. 2015 May;151(5):555-6.
3 Carrasco D et al. An Open Label, Phase 2 Study of MABp1 Monotherapy for the Treatment of Acne Vulgaris and Psychiatric Comorbidity. J Drugs Dermatol. 2015 Jun;14(6):560-4.
4 Kanni T et al. MABp1 Targeting Interleukin-1Alpha for Moderate to Severe Hidradenitis Suppurativa not Eligible for Adalimumab: A Randomized Study. J Invest Dermatol. 2017 Nov 9.
5 Revuz J. Hidradenitis suppurativa. J Eur Acad Dermatol Venereol 2009; 23: 985-998.
6 Alikhan A, Lynch PJ, Eisen DB. Hidradenitis suppurativa: a comprehensive review. J Am Acad Dermatol. 2009 Apr;60(4):539-61; quiz 562-3. doi: 10.1016/j.jaad.2008.11.911.
7 Vasquez BG, Alikhan A, Weaver, AL, et al. Incidence of hidradenitis suppurativa and associated factors: a population-based study of Olmsted County, Minnesota. J Invest Dermatol. 2013 Jan;133(1):97-103. doi: 10.1038/jid.2012.255. Epub 2012 Aug 30.
8 Révuz JE, Canoui-Poitrine F, Wolkenstein P, et al. Prevalence and factors associated with hidradenitis suppurativa: results from two case-control studies. J Am Acad Dermatol 2008; 59: 695-701.
The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.
Source: XBiotech, Inc via Globenewswire
One Liberty Plaza - 165 Broadway
NY 10006 New York
GlobeNewswire is one of the world's largest newswire distribution networks, specializing in the delivery of corporate press releases financial disclosures and multimedia content to the media, investment community, individual investors and the general public.
Følg saker fra GlobeNewswire
Registrer deg med din epostadresse under for å få de nyeste sakene fra GlobeNewswire på epost fortløpende. Du kan melde deg av når som helst.
Siste saker fra GlobeNewswire
Avis Budget Group Wins Multiple Awards in the Middle East26.4.2019 12:43:00 CEST | Pressemelding
LONDON, April 26, 2019 (GLOBE NEWSWIRE) -- Avis Budget Group has been awarded multiple accolades at the 2019 World Travel Awards, for its car rental brands Avis and Budget, across the Middle East, it was announced at an awards ceremony in Abu Dhabi last night. The 26th annual World Travel Awards is globally recognized as a highly prestigious honours programme in global travel and tourism. The awards are voted for by travel and tourism professionals and consumers worldwide, and this honour recognises the brands’ commitment to excellence, with an ultimate industry accolade. The awards won by these licensee markets within Avis Budget Group include: Middle East's Leading Business Car Rental Company 2019: Avis Bahrain's Leading Car Rental Company 2019: Avis Iraq's Leading Car Rental Company 2019: Avis Kuwait's Leading Car Rental Company 2019: Avis Lebanon's Leading Car Rental Company 2019: Avis Oman's Leading Car Rental Company 2019: Avis United Arab Emirates’ Leading Car Rental Company 201
Mohawk Industries Reports Q1 Results25.4.2019 22:15:00 CEST | Pressemelding
CALHOUN, Ga., April 25, 2019 (GLOBE NEWSWIRE) -- Mohawk Industries, Inc. (NYSE: MHK) today announced 2019 first quarter net earnings of $122 million and diluted earnings per share (EPS) of $1.67. Adjusted net earnings were $154 million, and EPS was $2.13, excluding restructuring, acquisition and other charges. Net sales for the first quarter of 2019 were $2.44 billion, up 1% in the quarter and 6% on a constant currency and days basis. For the first quarter of 2018, net sales were $2.41 billion, net earnings were $209 million and EPS was $2.78, adjusted net earnings were $225 million, and EPS was $3.01, excluding restructuring, acquisition and other charges. Commenting on Mohawk Industries’ first quarter performance, Jeffrey S. Lorberbaum, Chairman and CEO, stated, “In the first quarter, we delivered results in-line with the high end of our expectations despite economies weakening in most regions and a stronger U.S. dollar, reducing our translated results. While U.S. housing markets beg
Oxford Immunotec Schedules First Quarter 2019 Earnings Release and Conference Call for May 9, 201925.4.2019 22:05:00 CEST | Pressemelding
OXFORD, United Kingdom and MARLBOROUGH, Mass., April 25, 2019 (GLOBE NEWSWIRE) -- Oxford Immunotec Global PLC (Nasdaq:OXFD) (the "Company"), a global, high-growth diagnostics company, today announced that it plans to release first quarter 2019 financial results before the open of the market on Thursday, May 9, 2019. Dr. Peter Wrighton-Smith, Chief Executive Officer, and Matt McLaughlin, Chief Financial Officer, will host a conference call to review the Company's financial results at 8:00 a.m. Eastern Time the same day. The call will be concurrently webcast. To listen to the conference call on your telephone, please dial (855) 363-5047 for United States callers or +1 (484) 365-2897 for international callers and reference confirmation code 6687808, approximately ten minutes prior to start time. To access the live audio webcast or subsequent archived recording, visit the Investor Relations section of Oxford Immunotec's website at www.oxfordimmunotec.com. The replay will be available on th
Novavax to Host Conference Call to Discuss First Quarter Financial Results on May 2, 201925.4.2019 22:05:00 CEST | Pressemelding
GAITHERSBURG, Md., April 25, 2019 (GLOBE NEWSWIRE) -- Novavax, Inc. (Nasdaq: NVAX) today announced it will report its first quarter 2019 financial and operating results following the close of U.S. financial markets on Thursday, May 2, 2019. Conference call details are as follows: Date: May 2, 2019 Time: 4:30 p.m. U.S. Eastern Time (ET) Dial-in number: (877) 212-6076 (Domestic) or (707) 287-9331 (International) Passcode: 5394082 Webcast: www.novavax.com, “Investors”/ “Events” Conference call and webcast replay: Dates: Starting at 7:30 p.m. ET, May 2, 2019 until 7:30 p.m. ET May 9, 2019 Dial-in number: (855) 859-2056 (Domestic) or (404) 537-3406 (International) Passcode: 5394082 Webcast: www.novavax.com, “Investors”/ “Events”, until August 2, 2019 About Novavax Novavax, Inc. (Nasdaq:NVAX) is a late-stage biotechnology company that drives improved health globally through the discovery, development, and commercialization of innovative vaccines to prevent serious infectious diseases. Its tw
BGRS Acquired by Relo Group, Inc.25.4.2019 17:55:00 CEST | Pressemelding
CHICAGO and TOKYO, April 25, 2019 (GLOBE NEWSWIRE) -- Relo Group, Inc. (“Relo Group”) and BGRS (“BGRS” or the “Company”) announced today that they have entered into a definitive agreement under which an affiliate of Relo Group will acquire BGRS, a leading global talent mobility management firm from Brookfield Business Partners. Leading the global mobility industry with innovative outsourcing and fully integrated solutions, BGRS provides a full spectrum of talent mobility and advisory services to Global Fortune 500 companies. Supported by a team of over 1,300 globally, BGRS manages over 60,000 employee relocations annually with locations throughout Asia, the Americas and EMEA. BGRS Chief Executive Officer, Traci Morris, and the management team will remain in place and work with Relo Group to advance the Company into its next phase. “BGRS has developed into a world class talent mobility management firm by always putting the interests of our clients first, constantly innovating and search
Ascom adds ‘talk before walk’ wireless speech function to new release of Ascom teleCARE IP25.4.2019 14:00:00 CEST | Pressemelding
New feature helps reduce caregivers’ walking time; enables more streamlined workflows in elderly care facilities BAAR, Switzerland, April 25, 2019 (GLOBE NEWSWIRE) -- Ascom (SWX:ASCN.SW), a global solutions provider focused on healthcare ICT and mobile workflow solutions, has added wireless speech functionality to its latest version of the Ascom teleCARE IP emergency call system. The new feature promises to help reduce the time spent by staff walking to investigate calls from residents in continuing and elderly care facilities. Ascom teleCARE IP has always had hardwired speech functionality. But by making it wireless, residents can simply use their normal mobile phones to communicate directly with caregivers via Ascom teleCARE IP. Caregivers can communicate with residents while on the go, and can deal with residents’ calls before walking to investigate. The newly released (Ascom teleCARE IP 12) is available globally. The latest version also features several technical enhancements inclu