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
Om Nasdaq GlobeNewswire
One Liberty Plaza - 165 Broadway
NY 10006 New York
+1 212 401 8700http://www.nasdaqomx.com
NASDAQ (NASDAQ: NDAQ) is a leading provider of trading, exchange technology, information and public company services across six continents.
Følg saker fra Nasdaq GlobeNewswire
Registrer deg med din epostadresse under for å få de nyeste sakene fra Nasdaq GlobeNewswire på epost fortløpende. Du kan melde deg av når som helst.
Siste saker fra Nasdaq GlobeNewswire
Wencor Group Announces Acquisition of Silver Wings14.11.2018 15:58 | Pressemelding
Peachtree City, GA, Nov. 14, 2018 (GLOBE NEWSWIRE) -- WENCOR GROUP ANNOUNCES ACQUISITION OF SILVER WINGS Peachtree City, GA (November 8th, 2018) -- Wencor Group (“Wencor”), a leading solutions provider to the aerospace aftermarket, today announced the acquisition of Silver Wings Aerospace, a certified 145 repair station specializing in electric power and hydraulic component repair with unique capabilities in Used Serviceable Material (“USM”). Terms of the transaction were not disclosed. "We are pleased to welcome Silver Wings leadership and their employees to the Wencor team. This partnership aligns with our strategy to drive ATA chapter depth and proprietary component repair capabilities while enhancing our presence in USM. We are thrilled to partner with great entrepreneurs like Eddie Montalvo and Sean Beaubien and look forward to working with the rest of their team who have developed a high quality customer-focused MRO business" said Chris Curtis, Chief Executive Officer of Wencor G
Kofax Advances Enterprise-Wide Deployment of Next-Generation Robotic Process Automation to Rapidly and Exponentially Scale the Digital Workforce14.11.2018 14:00 | Pressemelding
Kofax RPA Powers Industry’s First Single-Vendor Intelligent Automation Offering; Free 12-Month Trial Provides Time to Build, Deploy and Measure Results with No Commitment IRVINE, Calif., Nov. 14, 2018 (GLOBE NEWSWIRE) -- Kofax ®, a leading supplier of Intelligent Automation software to automate and digitally transform end-to-end business processes, today announced Kofax RPA’s next-generation robotic process automation (RPA) capabilities that leverage artificial intelligence (AI) and machine learning (ML). Providing “out-of-the-box” functionality, Kofax is first to market with a comprehensive, single-vendor, single-platform, Intelligent Automation solution. “Early adopters of RPA have experienced the many benefits in shifting human labor from ‘data gatherer’ to ‘data user’ roles. Increased productivity helps them remain on track for profitable growth, improved customer service and significant competitive advantage,” said Reynolds C. Bish, Chief Executive Officer of Kofax. “These excepti
Biome Grow subsidiary, Highland Grow, receives license to sell to other licensed producers from Health Canada14.11.2018 14:00 | Pressemelding
TORONTO, Nov. 14, 2018 (GLOBE NEWSWIRE) -- Biome Grow Inc. (“Biome” or the “Company”) (CSE:BIO) (Frankfurt:6OTA) is pleased to announce its Nova Scotia-based subsidiary, Highland Grow Inc. (“Highland Grow”), has received its license to sell to other licensed producers from Health Canada in accordance with subsection 11(5) of the Cannabis Regulations. "This license gives the company additional commercial sales avenues and flexibility for our high quality cannabis products and services that are ready for our customers," said Khurram Malik, CEO of Biome. The Health Canada license, issued in accordance with the Cannabis Act and Cannabis Regulations, specifically grants Highland Grow the ability to: possess cannabis; obtain dried cannabis, fresh cannabis, cannabis plants or cannabis plant seeds by cultivating, propagating, and harvesting cannabis; and, to sell cannabis in accordance with subsection 11(5) of the Cannabis Regulations. With this license, Highland Grow is positioned to sell and
Colliers International Expands in South Florida14.11.2018 13:30 | Pressemelding
Acquisition of Preeminent Brokerage and Management Firm Strengthens Leadership and Service Offering TORONTO and MIAMI, Nov. 14, 2018 (GLOBE NEWSWIRE) -- Leading global commercial real estate services and investment management firm Colliers International Group Inc. (NASDAQ and TSX: CIGI) today announced the acquisition of Continental Real Estate Companies Commercial Properties Corp. (“CREC”), a market-leading commercial real estate services firm specializing in property management, project management and sales and lease brokerage. Founded in 1989 by Warren Weiser and Carol Greenberg Brooks, this acquisition brings an extensive portfolio of more than 12.6 million square feet of office, industrial and retail space in Florida and more than 100 professionals operating from three offices throughout the state to Colliers. Terms of the transaction were not disclosed. “This strategic acquisition positions Colliers as the top management and retail brokerage firm in the vibrant South Florida mark
ADC Therapeutics Announces Presentations at 60th American Society of Hematology (ASH) Annual Meeting14.11.2018 13:30 | Pressemelding
New clinical data highlight potential of novel pyrrolobenzodiazepine-based antibody drug conjugates for the treatment of relapsed or refractory lymphomas LAUSANNE, Switzerland, Nov. 14, 2018 (GLOBE NEWSWIRE) -- ADC Therapeutics, an oncology drug discovery and development company that specializes in the development of proprietary antibody drug conjugates (ADCs), today announced that data from Phase I clinical trials of ADCT-402 (loncastuximab tesirine) and ADCT-301 (camidanlumab tesirine) have been selected for oral and poster presentations at the 60th American Society of Hematology (ASH) Annual Meeting, which is being held December 1-4 in San Diego. Jay Feingold, MD, PhD, Chief Medical Officer and Senior Vice President of Clinical Development at ADC Therapeutics, said, “We look forward to sharing updated data from our first-in-human clinical trials of ADCT-402 and ADCT-301 in multiple subtypes of lymphoma at the 2018 ASH Annual Meeting. Interim data show that ADCT-402, which targets CD
Major telco company partners with Vricon to accelerate 5G rollouts across the USA14.11.2018 13:00 | Pressemelding
Vricon supports major U.S. telecommunications firm with high-resolution 3D geodata for urban and suburban regions across the United States McLean, VA, Nov. 14, 2018 (GLOBE NEWSWIRE) -- Vricon is pleased to announce that a major U.S. telecommunications company recently acquired Vricon’s high-resolution 3D geodata to support large-scale 5G telecommunications network planning and design. Under the multimillion-dollar contract, Vricon will provide the firm with 3D data of urban and suburban population centers across the United States. The company is leveraging Vricon’s recent innovations in mapping to accelerate 5G infrastructure planning nationwide. 5G increases the need for accurate, high-resolution geodata. Vricon’s unique big-data solution uses the world’s largest archive of 50cm commercial satellite imagery; the solution is built using automated 3D modeling algorithms that create cost-effective, scalable geodata. By adopting Vricon’s unique mapping technology, telecommunications compa
I vårt presserom finner du alle våre siste saker, kontaktpersoner, bilder, dokumenter og annen relevant informasjon om oss.Besøk vårt presserom