XBiotech Announces Presentation of Phase 2 Open Label Extension Study Data Evaluating MABp1 for the Treatment of Hidradenitis Suppurativa
Open Label Extension Results, which Demonstrate Significant Improvements in HS Patients Previously Treated with Placebo, will be Presented at the 7th Conference of the European Hidradenitis Suppurativa Foundation (EHSF)
AUSTIN, Texas, Jan. 19, 2018 (GLOBE NEWSWIRE) -- XBiotech Inc. (NASDAQ:XBIT) announced today that results from an open label extension (OLE) phase of the 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 Hidradenitis Suppurativa Foundation (EHSF) Conference occurring in Rotterdam Netherlands February 7-9th. The oral presentation titled, "An open-label extension study of MABp1 targeting interleukin-1alpha for hidradenitis suppurativa (HS)" will be given by Theodora Kanni, M.D., Ph.D., Attikon University Hospital in Athens Greece, on 8 February 2018 between 1:50 and 2:50pm local time.
The findings being presented come from patients that had received placebo in a previous Phase 2 double-blind, placebo-controlled study. Patients that had originally been allocated to placebo in the Phase 2 study were allowed to receive treatment with the MABp1 antibody therapy in a so called open label extension (OLE) study. Seven of 10 patients that had originally received placebo were treated with MABp1 for 12 weeks. Main endpoints used in the OLE included safety and HiSCR score at the end of the 12 week treatment. At the conclusion of the double-blinded study, only one patient (1 of 10, or 10%) receiving placebo had achieved HiSCR. During the OLE, five patients (5 of 7, or 71.4%) achieved the HiSCR response (p=0.035). There was a total of 24 HS exacerbations during the blinded portion of the study compared to just 1 exacerbation during the OLE phase.
Prof. Evangelos Giamarellos-Bourboulis, M.D., Ph.D., who supervises the Outpatients Department for HS of the 4th Department of Internal Medicine at Attikon University Hospital in Athens, Greece where the study was conducted and also served as the Principal Investigator of the study, commented, "Results of the OLE crossover study provide further compelling evidence of the activity for MABp1 in HS. We will work diligently to expand this work and avail this treatment to patients in need."
Results of the Phase 2 study were recently published in the Journal of Investigative Dermatology, 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 included assessment of HiSCR scores, a validated method for evaluating efficacy in HS patients, as well as quality of life assessment and ultrasonographic evaluation.
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 abscesses1,2. Therefore, HS is often devastating for patients with significant impact on quality of life3. The Dermatology Life Quality Index (DLQI) for HS is 8.9, being higher than any other skin disorder4. 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
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
Resverlogix Provides Unrestricted Educational Grant for Epigenetic Symposium at International Renal Congress25.5.2018 07:45 | Pressemelding
CALGARY, Alberta, May 24, 2018 (GLOBE NEWSWIRE) -- Resverlogix Corp. ("Resverlogix" or the "Company") (TSX:RVX) today announced that on Friday, May 25, 2018, at the European Renal Association - European Dialysis and Transplant Association (ERA-EDTA) Congress in Copenhagen, Denmark, the Company is supporting a symposium titled: "Epigenetics in CKD & CVD: A potential breakthrough therapy?" The symposium highlights the role of epigenetics and BET-inhibition in chronic kidney disease and cardiovascular disease, especially in patients with diabetes mellitus, and the significant unmet need that still exists in this patient population. The symposium is co-chaired by Vincent M. Brandenburg, MD - Nephrologist, Aachen, Germany and Kamyar Kalantar-Zadeh, MD - UC Irvine School of Medicine, Irvine, CA, USA, both leading scientists also serving as advisors to Resverlogix's Renal program. The speakers and agenda are as follows: Introduction Vincent M. Brandenburg, MD - University Hospital of the RWTH
Atico Reports Consolidated Financial Results for the First Quarter of 201824.5.2018 22:30 | Pressemelding
(All amounts expressed in US dollars, unless otherwise stated) VANCOUVER, British Columbia, May 24, 2018 (GLOBE NEWSWIRE) -- Atico Mining Corporation (the "Company" or "Atico") (TSX.V:ATY) (OTC:ATCMF) today announced its financial results for the three months ended March 31, 2018, posting a net income of $0.4 million. Fernando E. Ganoza, CEO and Director, commented, "The strong production and all-in sustaining cash cost of $1.85 achieved this quarter is not reflected in the financial results as a large concentrate shipment was delayed to the second quarter, along with the revenue associated with those tonnes. The shipping schedule is expected to stabilize during the second quarter, where we will then benefit from the additional shipped concentrate and recognized revenue. We anticipate strong financial results in the next quarter." Mr. Ganoza continued, "Our emphasis will continue to be on further strengthening our balance sheet, improving production costs and most importantly regional
Luxembourg Announced as SNOMED International's Newest Member24.5.2018 15:16 | Pressemelding
London, United Kingdom, May 24, 2018 (GLOBE NEWSWIRE) -- SNOMED International and Agence eSanté Luxembourg are pleased to announce that Luxembourg has joined the organization as its thirty-second Member. Luxembourg, one of the leading nations in the area of information and communication technology, has set the development of eHealth technologies as a high priority. Agence eSanté, Luxembourg's national agency for the exchange and sharing of medical data, has set an overall mission to facilitate clinical information exchange both within Luxembourg and across other international actors. To work towards this reality, the agency has taken part in discussions about standardization across Europe, a contributing building block achieved with its membership in SNOMED International. With their membership, Agence eSanté has committed their support for the use of structured clinical terminology. When applied to the health sector, interoperability ensures that information systems, and through them h
SEMAFO Signs Underground Mining Services Contract with AUMS24.5.2018 14:00 | Pressemelding
MONTREAL, May 24, 2018 (GLOBE NEWSWIRE) -- SEMAFO Inc. (TSX:SMF) (OMX:SMF) reports that it has signed a mining services contract with African Underground Mining Services ("AUMS") to provide turnkey mining services for Siou underground. AUMS is a well-known and reputable mining contractor with underground experience in Burkina Faso and across Africa. Under the mining services contract, AUMS will be responsible for supplying the mining fleet and a skilled labour force for Siou underground in addition to ensuring development, production and auxiliary services. SEMAFO will provide technical services including geology and engineering as well as leveraging the existing surface infrastructure at Mana. The mining services contract has a term of 70 months. The economic terms of the mining services contract are consistent with the economics presented in the Mana pre-feasibility study filed March 29, 2018 on SEDAR. Preparatory work has already commenced on Siou underground with full project deplo
Merus Announces First Patient Dosed in Phase 1 Clinical Trial of MCLA-158 in Patients with Solid Tumors24.5.2018 13:00 | Pressemelding
- IND Accepted in April by the U.S. FDA for MCLA-158 - UTRECHT, The Netherlands, May 24, 2018 (GLOBE NEWSWIRE) -- Merus N.V. (Nasdaq:MRUS), a clinical-stage immuno-oncology company developing innovative bispecific antibody therapeutics (Biclonics®), today announced that the first patient has been dosed in a Phase 1, first-in human clinical trial of MCLA-158 in patients with solid tumors with an initial focus on metastatic colorectal cancer. The trial will be conducted in Europe, where several Clinical Trial Applications (CTAs) have been approved to date. The Company also announced the submission of an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for MCLA-158, which was accepted by the FDA in April 2018. With this acceptance, Merus plans to open additional sites for this trial in the United States. MCLA-158 is designed to bind to cancer stem cells expressing leucine-rich repeat-containing G protein-coupled receptor 5 (Lgr5) and epidermal grow
PRA Named International Clinical Research Company of the Year24.5.2018 10:00 | Pressemelding
RALEIGH, N.C., May 24, 2018 (GLOBE NEWSWIRE) -- PRA Health Sciences, Inc. (NASDAQ:PRAH) is pleased to announce it was recognized by PharmaTimes as the International Clinical Research Company of the Year. This is the fifth year in a row that PRA has received this award. "This award celebrates excellence in the clinical research industry and we are honored to once again be recognized by our peers," said Colin Shannon, President and Chief Executive Officer. "This award is possible thanks to the incredibly talented PRA team members we have working around the world who are deeply committed to their work in bringing new and life-saving therapies to the patients who need them." PRA also swept the Clinical Research Associate and Clinical Trial Administrator categories capturing a total of 11 awards. These awards follow PRA's recognition earlier this month in the PharmaTimes Americas competition where PRA also received 11 awards, including Company of the Year. The PharmaTimes, International Cli
I vårt presserom finner du alle våre siste saker, kontaktpersoner, bilder, dokumenter og annen relevant informasjon om oss.Besøk vårt presserom