XBiotech Announces Presentation of Phase 2 Study Data Evaluating MABp1 for the Treatment of Hidradenitis Suppurativa
Results of the Randomized Phase 2 Study Evaluating MABp1 for the Treatment of Hidradenitis Suppurati
AUSTIN, Texas, Sept. 07, 2017 (GLOBE NEWSWIRE) -- XBiotech Inc. (NASDAQ:XBIT) announced today that results from the investigator sponsored randomized Phase 2 study evaluating XBiotech's True Human(TM) antibody, MABp1, as a treatment for Hidradenitis Suppurativa (HS) will be presented at the European Academy of Dermatology and Venereology (EADV) Congress in Geneva Switzerland. The oral presentation titled, "MABp1, a monoclonal antibody targeting interleukin 1 alpha in patients with hidradenitis suppurativa not eligible for adalimumab: results of a phase II randomized clinical trial" will be given by Theodora Kanni, M.D., Ph.D., Attikon University Hospital in Athens Greece, on 14 September 2017 at approximately 2pm local time.
Prof. Evangelos Giamarellos-Bourboulis, M.D., Ph.D., who supervises the Outpatients Department for HS of the 4th Department of Medicine at Attikon University Hospital in Greece where the study was conducted and also served as the Principal Investigator of the study, commented, "Hidradenitis is a chronic inflammatory disease with devastating morbidity. It is far too common in our clinic and we do not yet have adequate treatments available. We are truly excited about the results of this clinical study and the potential for MABp1 as a therapy. We look forward to sharing this data with the medical community."
XBiotech announced topline results earlier this year, reporting that the study met its primary endpoint and demonstrated a significant improvement in HS patients treated with MABp1 compared to control after 12 weeks of therapy (Response rate of 60% vs 10%, respectively (p=0.035)). The 20 patient double-blind, placebo-controlled study was designed to evaluate the safety and efficacy of MABp1, the Company's True Human antibody targeting interleukin-1 alpha (IL-1alpha), in patients with HS not eligible for anti-TNF therapy. Patients were randomized 1:1 to receive either MABp1 or placebo every 2 weeks for 12 weeks. Patients in the study underwent primary assessment of efficacy using Hidradenitis Suppurativa Clinical Response (HiSCR) scores at 12 weeks, continued by a follow up phase to assess time to relapse after an additional 12 weeks without therapy. Efficacy measures include assessment of HiSCR scores, a validated method for evaluating efficacy in HS patients, as well as quality of life assessment and ultrasonographic evaluation. Results of the Phase 2 study are planned for publication later this year.
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 abscesses 1,2. Therefore, HS is often devastating for patients with significant impact on quality of life 3. The Dermatology Quality Life Index (DQLI) for HS is 8.9, being higher than any other skin disorder 4. Traditional treatments comprise of antibiotics, antiandrogens and surgery. Prevalence rates for HS have been estimated at up to 4%2.
About True Human(TM) Therapeutic Antibodies
Unlike previous generations of antibody therapies, XBiotech's True Human(TM) antibodies are derived without modification from individuals who possess natural immunity to certain diseases. With discovery and clinical programs across multiple disease areas, XBiotech's True Human antibodies have the potential to harness the body's natural immunity to fight disease with increased safety, efficacy and tolerability.
XBiotech is a fully integrated global biosciences company dedicated to pioneering the discovery, development and commercialization of therapeutic antibodies based on its True Human(TM) proprietary technology. XBiotech currently is advancing a robust pipeline of antibody therapies to redefine the standards of care in oncology, inflammatory conditions and infectious diseases. Headquartered in Austin, Texas, XBiotech also is leading the development of innovative biotech manufacturing technologies designed to more rapidly, cost-effectively and flexibly produce new therapies urgently needed by patients worldwide. 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 Revuz J. Hidradenitis suppurativa. J Eur Acad Dermatol Venereol 2009; 23: 985-998.
2 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.
3 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.
4 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
Följ NASDAQ OMX
Abonnera på våra pressmeddelanden.
Senaste pressmeddelandena från NASDAQ OMX
Winners in 2018 Asia-Pacific Stevie® Awards Announced23.4.2018 04:00 | Pressmeddelande
Honorees for Innovation in Business to Be Recognized in Hong Kong on 1 June FAIRFAX, Va., April 22, 2018 (GLOBE NEWSWIRE) -- Winners in the fifth annual Asia-Pacific Stevie® Awards, the only awards program to recognize innovation in business throughout the entire Asia-Pacific region, were announced today. The list of Gold, Silver and Bronze Stevie Award winners is available at http://Asia.StevieAwards.com. The Stevie Awards are considered to be the world's premier business awards, conferring recognition for achievement in the workplace over the past 16 years in programs such as The International Business Awards® and The American Business Awards®. The 2018 Asia-Pacific Stevie Awards have recognized organizations in 14 nations including Australia, China, India, Indonesia, Japan, Malaysia, Myanmar, Philippines, Singapore, South Korea, Taiwan, Thailand, the U.S.A. and Vietnam. More than 800 nominations about innovative achievements in the 22-nation APAC region were considered by the judges
Gratomic and Perpetuus Carbon Technologies Limited Enter Into an Agreement for the Exclusive Development and Marketing of Material Enhancing Graphenes Derived From Gratomic Aukam Graphite22.4.2018 22:00 | Pressmeddelande
TORONTO, April 22, 2018 (GLOBE NEWSWIRE) -- Gratomic Inc. ("GRAT" or the "Company") (TSX-V:GRAT) (FRANKFURT:CB81) (WKN:A2JAP3). Gratomic Inc., is pleased to announce that the Company has signed a letter of collaboration ("Agreement") with Perpetuus Carbon Technologies Limited ("Perpetuus") pursuant to which GRAT and Perpetuus will develop and market material enhancing graphite derived graphenes and graphene hybrids for tire elastomers, whilst also exploring options to exploit polymer composites, energy capture and storage applications markets ("Project"). The Agreement contemplates the first Phase of the Project ("Phase 1"), with the other phases to be described in a joint venture agreement to be entered into between GRAT and Perpetuus. Pursuant to the Agreement, and as part of Phase 1, GRAT will purchase, and retain ownership, of three specialised process tooling chambers at an aggregate cost of 300,000 British Pounds. These specialized tooling chambers will be housed in Perpetuus' ex
Arc Aroma Pure AB : 180420 ARCAROMA stärker informationsflödet till den finansiella marknaden20.4.2018 15:20 | Pressmeddelande
Pressrelease 2018-04-20 A rc Aroma Pure AB ("ARCAROMA") möter det ökade intresset hos investerare och aktiverar en ny tjänst. ARCAROMA kommer att publicera nyhetsbrev med en mer djuplodande information om bolaget, strategier och framsteg. Skälet är ett kraftigt ökat intresse från marknaden, kanske som resultat av en ägarspridning. Även de restriktioner som numera finns hos marknaden avseende finansiella pressmeddelande spelar in. Det första nyhetsbrevet kommer att släppas under vecka 17 på bolagets Investor sida www.investor.arcaroma.se. På investor.arcaroma.se kommer det att finnas en länk till nyhetsbreven och till en sida där allmänheten har möjlighet att anmäla sig till en prenumerationstjänst. Målsättningen är att nyhetsbreven skall släppas periodiskt och i även samband med händelser som förtjänar en mer detaljerad information än vad som ryms i ett finansiellt pressmeddelande. Det är vår förhoppning att bolaget på detta sätt kan tillfredsställa det ökande behov av information som
Abeona Therapeutics Receives Orphan Drug Designation in the European Union for ABO-202 Gene Therapy Program in Batten Disease20.4.2018 14:15 | Pressmeddelande
NEW YORK and CLEVELAND, April 20, 2018 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (NASDAQ:ABEO), a leading clinical-stage biopharmaceutical company focused on developing novel cell and gene therapies for life-threatening rare genetic diseases, announced today that the European Medicines Agency (EMA) Committee for Orphan Medicinal Products has granted Orphan Drug Designation (EMA/OD/013/18) for Abeona's gene therapy program ABO-202 for the treatment of subjects with neuronal ceroid lipofuscinosis, also known as Batten Disease, a fatal lysosomal storage disease that primarily affects the nervous system in children. ABO-202 is an adeno-associated virus developed to introduce a functional copy of the CLN1 gene into cells in order to restore the enzyme activity that is needed to break down certain lipopigment proteins that are deficient in patients with CLN1 disease. "This designation is an important step in our CLN1 program as it encourages us to proceed towards clinical development," st
Taconic Biosciences Licenses Easi-CRISPR Technology from the University of Nebraska20.4.2018 14:00 | Pressmeddelande
RENSSELAER, N.Y., April 20, 2018 (GLOBE NEWSWIRE) -- Taconic Biosciences, a global leader in providing genetically engineered mouse model and service solutions, has been granted a license to the Easi-CRISPR technology from the University of Nebraska. Easi-CRISPR was developed in the laboratories of Drs. Masato Ohtsuka (Tokai University in Japan), and Channabasavaiah Gurumurthy (University of Nebraska). The terms of the agreement include a world-wide, non-exclusive license to the technology, allowing Taconic rights to generate and sell rodent models generated via Easi-CRISPR. When compared to traditional CRISPR, Easi-CRISPR represents a significant advantage, allowing researchers to perform whole genetic insertions versus being limited to point mutations and constitutive knockouts. "Easi-CRISPR is the next progression of the revolutionary CRISPR/Cas technology. Combining the speed of CRISPR with larger genetic insertions allows complex projects typically requiring homologous recombinati
LeoVegas new principal partner for Swedish Open20.4.2018 11:30 | Pressmeddelande
The LeoVegas Mobile Gaming Group is expanding its sponsoring partnership with the Swedish Open in Båstad by assuming the role as a principal partner for the prestigious tennis tournament. "Last year's successful sponsor partnership with the Swedish Open in Båstad was a strategic effort to profile LeoVegas Sport and our offering in tennis. This venture whet our appetite, and we have therefore chosen to ramp up our sponsorship from Official Partner to become one of the Swedish Open's Principal Partners," comments Gustaf Hagman, Group CEO. Betting on tennis - especially live betting via mobile devices - is one of the gaming categories which in terms of turnover is growing the fastest in most of LeoVegas markets. Live betting puts high demands on technology and is well in line with LeoVegas' ambition to continuously deliver the best mobile gaming experience. Louise Nylén, LeoVegas' Chief Marketing Officer, comments: "Our sponsoring partnership with the Swedish Open in Båstad strengthens ou
I vårt pressrum kan du läsa de senaste pressmeddelandena, få tillgång till pressmaterial och hitta kontaktinformation.Besök vårt pressrum