Nasdaq GlobeNewswire

XBiotech Announces Agreement with Cedars-Sinai Medical Center to Evaluate MABp1 in Combination with Onivyde® and 5-fluorouracil/folinic acid for the Treatment of Pancreatic Cancer

Del

AUSTIN, Texas, Sept. 20, 2017 (GLOBE NEWSWIRE) -- XBiotech Inc. (NASDAQ:XBIT) announced today its agreement with Cedars-Sinai Medical Center located in Los Angeles, California, whereby XBiotech will provide its interleukin-1 alpha antagonist, MABp1, for a Phase I single arm study evaluating the maximum tolerated dose of Onivyde® (Irinotecan liposome injection) and 5-fluorouracil/folinic acid in combination with MABp1 in a cohort of patients with advanced pancreatic adenocarcinoma and cachexia. The study will also assess efficacy using various secondary measures including changes in lean body mass, weight stability, IL-6 levels, overall and progression free survival as well as evaluation of the relationship between treatment tolerance and patient functional status.

Andrew Hendifar, M.D., Medical Oncology lead for the Gastrointestinal Disease Research Group at Cedars-Sinai and Co-Director of Pancreas Oncology, will be leading the study which is planned to enroll a total of 16 patients at the Cedars-Sinai Medical Center. Onivyde will be given intravenously with MABp1 and 5-fluorouracil/folinic acid every two weeks until disease progression.

Dr. Hendifar commented, "The results to date with treatment of MABp1 show much promise as an effective therapy in this setting. I look forward to evaluating this combination therapy to determine its safety and clinical benefit."

Despite decades of clinical trials, the prognosis for advanced pancreatic cancer is poor [1].  The 5-year survival has remained close to 5% and unchanged despite improvements in chemotherapeutics, surgical outcomes, and diagnostic techniques [1, 2].  Advanced pancreatic adenocarcinoma is characterized by progressive weight loss and nutritional deterioration [3].  It is estimated that up to 80% of these patients present with cachexia [4].  This syndrome has been linked not only to survival, but also to alterations in host defenses, functional ability, and quality of life. In a Phase III clinical study, MABp1 was found to improve clusters of symptoms that included reduced pain, fatigue, improved appetite and increased lean body mass. Patients that had these improvements were found to have reduced disease progression and serious adverse events, and about a three-fold improvement in survival.

Other than multi-agent cytotoxic therapy there have been no treatment advances for pancreatic cancer or its associated cachexia. Despite the availability of effective chemotherapy, only between 15-40% of pancreatic cancer patients are able to receive second line treatment. Importantly, cachexia and its associated fatigue and deconditioning, may explain the difficulty in providing continued therapy after progression in the first-line. It is hoped that MABp1 used in combination with Onivyde will help control disease, reduce symptoms and allow patients to receive treatment longer, thereby improving outcomes.

About True Human(TM) Therapeutic Antibodies
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.

About XBiotech
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.

Contact
Ashley Otero
aotero@xbiotech.com
512-386-2930

1. Li, D., et al., Pancreatic cancer. Lancet, 2004. 363(9414): p. 1049-57.
2. Panagiotarakou, M., et al., Use of supportive care for symptom management in pancreatic cancer: application of clinical research to patient care. Jop, 2012. 13(4): p. 342-4.
3. Splinter, T.A., Cachexia and cancer: a clinician's view. Ann Oncol, 1992. 3 Suppl 3: p. 25-7.
4. Ryan, D.P. and M.L. Grossbard, Pancreatic Cancer: Local Success and Distant Failure. Oncologist, 1998. 3(3): p. 178-188.




This announcement is distributed by Nasdaq Corporate Solutions on behalf of Nasdaq Corporate Solutions clients.
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

Nasdaq GlobeNewswire
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

VIRGIN PULSE ANNOUNCES INDUSTRY-LEADING GDPR COMPLIANCE25.5.2018 14:00Pressemelding

Virgin Pulse Extends the GDPR's Strong Data Privacy Rights to All Clients and Members Across the Globe PROVIDENCE, R.I., May 25, 2018 (GLOBE NEWSWIRE) -- Virgin Pulse, the leading global provider of digital employee health, wellbeing and engagement solutions, today announced that it has achieved compliance with the EU General Data Protection Regulation (GDPR) for the Virgin Pulse platform. The company has also appointed Associate Counsel Beatrice Botti as Data Protection Officer (DPO) to oversee the Virgin Pulse privacy program. With this achievement, Virgin Pulse leads the market as the first company in the wellbeing and engagement industry to fully meet the comprehensive standards of the new GDPR data privacy law. The company has completed a thorough review of its internal data collection, storage and handling processes and implemented enhancements to achieve GDPR compliance and give all Virgin Pulse customers and members greater control over their personal data. The GDPR is the firs

Resverlogix Provides Unrestricted Educational Grant for Epigenetic Symposium at International Renal Congress25.5.2018 07:45Pressemelding

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 22:30Pressemelding

(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 15:16Pressemelding

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 14:00Pressemelding

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 13:00Pressemelding

- 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

I vårt presserom finner du alle våre siste saker, kontaktpersoner, bilder, dokumenter og annen relevant informasjon om oss.

Besøk vårt presserom