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
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 . 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 . It is estimated that up to 80% of these patients present with cachexia . 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.
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. 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.
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
Skriv in din e-postadress så får du ett mejl när vi har något nytt att berätta.
Senaste pressmeddelandena från NASDAQ OMX
H.B. Fuller Poised for Global Growth with Acquisition of Royal Adhesives & Sealants23.10.2017 02:00 | Pressmeddelande
ST. PAUL, Minn., Oct. 22, 2017 (GLOBE NEWSWIRE) -- Boosting H.B. Fuller's (NYSE:FUL) problem-solving potential, the company today announces it has finalized its acquisition of Royal Adhesives & Sealants for $1.575 billion. Few people realize the impact of adhesives. They are everywhere, making virtually any durable or consumer product better. Adhesives have the potential to make the world a better place, and H.B. Fuller is tapping adhesives in unique ways to improve a range of global issues. H.B. Fuller, combined with Royal, deepens its expertise in specialty and high-value applications used in a range of sectors, including electronics, hygiene, medical, transportation, clean energy, construction, and more. Together, the companies will enable an interconnected world, support better use of the world's finite resources, improve food security and access to clean drinking water, and address the challenges of a globally disperse and aging population. "This is an exciting step
Nasdaq Welcomes RISE Education Cayman Ltd. (Nasdaq: REDU) to The Nasdaq Stock Market20.10.2017 18:37 | Pressmeddelande
NEW YORK, Oct. 20, 2017 (GLOBE NEWSWIRE) -- RISE Education Cayman Ltd. (Nasdaq:REDU), a leader in China's junior English Language Training (ELT) market, rang the opening bell at the Nasdaq MarketSite in Times Square today in celebration of its initial public offering (IPO) on The Nasdaq Stock Market. Photos accompanying this announcement are available at http://www.globenewswire.com/NewsRoom/AttachmentNg/f59490cf-9a81-4114-92a1-05edcb3f5694 http://www.globenewswire.com/NewsRoom/AttachmentNg/5692f99d-9ed0-4be2-928d-9c94f4b152e8 RISE pioneered the "subject-based learning" teaching philosophy in China, whereby various subject matters, such as language arts, math, natural science and social science are used to teach English. RISE's course offerings use interactive courseware to create an immersive English learning environment that helps students learn to speak and think like a native speaker. In addition, their curricula are des
Concurrent Achieves Sales Milestone for Zephyr Transcode19.10.2017 15:35 | Pressmeddelande
Concurrent Customers Now Transcoding on Three Continents ATLANTA, Oct. 19, 2017 (GLOBE NEWSWIRE) -- Concurrent (NASDAQ:CCUR), a global leader in storage, protection, transformation, and delivery of visual media assets, announced today that Zephyr Transcode, which Concurrent launched last year as an integral part of its content delivery network (CDN) solutions, is now deployed with customers in Asia, Europe and North America. The deployments already support thousands of on-demand assets being transcoded to multiple formats and bit-rates to support any place, any device content availability. Zephyr Transcode supports multiple formats and quality levels including H.264 (MPEG-4) and H.265 (HEVC), strengthening Concurrent customers' capability to provide high-quality standards-based streams to any device their end-users desire. Zephyr Transcode is software-based and capable of running in traditional Central Processing Units (CPU) as well as Gra
German Armed Forces Renews Contract for Hexagon Geospatial Products19.10.2017 15:11 | Pressmeddelande
Defense agency will work closely with Hexagon Geospatial Premium Partner for next two years NORCROSS, Ga., Oct. 19, 2017 (GLOBE NEWSWIRE) -- At the HxGN LOCAL Defense Summit, a conference dedicated to defense and security in Western Europe, Hexagon Geospatial announced that the Bundeswehr Geoinformation Centre (BGIC) recently renewed a large software maintenance contract for Hexagon Geospatial products. The two-year renewal is for more than 100 licenses, mainly within the GeoMedia and ImageStation product families. The contract also includes consulting for workflow optimization. The contract was issued to Geosystems, a Hexagon Geospatial Premium Partner, which will work closely with the local subsidiary of Hexagon Safety & Infrastructure in Bonn and Munich to support BGIC. "The strong Hexagon Geospatial partner network allows our defense customers to benefit from a unique pool of expertise and tradecraft in the areas of remote sensing, GIS, and photog
Novel Preclinical Research Tools Provide Humanized Immune Response to Advance Immunotherapeutic Development, Live Webinar Hosted by Crown Bioscience19.10.2017 14:00 | Pressmeddelande
SANTA CLARA, Calif., Oct. 19, 2017 (GLOBE NEWSWIRE) -- Crown Bioscience, a wholly-owned subsidiary of Crown Bioscience International (TWSE:ticker 6554) and a global drug discovery and development services company providing translational platforms to advance oncology, inflammation, cardiovascular and metabolic disease research, announces a live webinar to be presented by Dr. Michelle Mack, Director of Global Scientific Engagement, entitled "Beyond Syngeneics - Novel Tools for Addressing Human Specificity in Immuno-Oncology." Checkpoint inhibitors like anti-PD-1, anti-PD-L1, and anti-CTLA-4 have revolutionized cancer treatment and have recently gained approval in several cancer types. Despite their potential, immunotherapies face significant development challenges due to the specificity and complexity of the human immune system upon which they act. Crown Bioscience has generated innovative research models to address these obstacles early during preclinical drug development.
Perfectus Aluminum Inc. Responds to Trade Group19.10.2017 13:00 | Pressmeddelande
ONTARIO, Calif., Oct. 19, 2017 (GLOBE NEWSWIRE) -- Perfectus Aluminum Inc. has issued the following: On October 12, 2017 the Aluminum Extruders Council (AEC), an industry group representing largely American aluminum extruders, posted to its blog a false narrative regarding a suit to which Perfectus Aluminum Inc. is a related party. The government is not "seeking unpaid duties from Perfectus for goods brought into the country." Rather, the government is attempting to use a 2017 Department of Commerce determination to assess retroactive antidumping duties on goods imported as early as 2011. It is discouraging that AEC would tout such an obviously egregious government overstep as a "victory" to their members and the industry: were it one of AEC's own members facing such an obvious violation of fair play and due process, it would rightfully argue that government overreach is a threat to manufacturers everywhere. In addition to the hypocrisy of the AEC's promotion of this case, its s
I vårt pressrum kan du läsa de senaste pressmeddelandena, få tillgång till pressmaterial och hitta kontaktinformation.Besök vårt pressrum