NASDAQ OMX

XBiotech Completes Dosing of Subjects in PK Study Being Conducted in Connection with European Marketing Application

22.2.2017 14:00 | NASDAQ OMX

Del

AUSTIN, Texas, 2017-02-22 14:00 CET (GLOBE NEWSWIRE) --

XBiotech Inc. (NASDAQ:XBIT) announced that all subjects have been dosed in its pharmacokinetic (PK) study evaluating MABp1 half-life in healthy volunteers. This Phase I study will provide further PK data and will enable additional characterization of the PK of MABp1 at a 7.5mg/kg IV dose. Safety and tolerability will also be assessed. PK analyses at various time points ranging from pre-infusion to 336 hours post infusion will be collected. The study is on schedule to be completed as planned for the Company’s upcoming regulatory submission.

The Company previously reported it had been granted an additional 30 days to submit its responses to the Day 180 List of Outstanding Issues (D180LOI) by the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) in connection with the Company’s Marketing Authorization Application for Xilonix. This extension was granted as a result of a clarification meeting held recently between XBiotech and the EMA. The extension was granted in order to allow sufficient time for the Company to complete the PK study in healthy subjects. These new PK data are intended to address relevant technical questions in the D180LOI and will be included in the Company’s response submission scheduled for March 22nd.

“We are happy to report the expeditious execution of this study, which will provide further PK data at multiple time points in the first 96 hours after dosing. This will enable additional and accurate characterization of the peak concentration, half-life and clearance, thus confirming PK is consistent with what would be expected from a monoclonal antibody,” commented Michael Stecher, XBiotech’s Medical Director. He further stated, “With these additional data in hand, we look forward to fully addressing the complete list of day 180 questions in March.”

About True Human™ Therapeutic Antibodies
XBiotech’s True Human™ 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™ 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

Om NASDAQ OMX

NASDAQ OMX
NASDAQ OMX
One Liberty Plaza - 165 Broadway
NY 10006 New York

+1 212 401 8700http://www.nasdaqomx.com

NASDAQ OMX (NASDAQ: NDAQ) is a leading provider of trading, exchange technology, information and public company services across six continents.

Følg saker fra NASDAQ OMX

Registrer deg med din epostadresse under for å få de nyeste sakene fra NASDAQ OMX på epost fortløpende. Du kan melde deg av når som helst.

Siste saker fra NASDAQ OMX

RedHill Biopharma Announces U.S. Commercialization Agreement for FDA-Approved GI Product Esomeprazole Strontium Delayed-Release Capsules17.8.2017 13:00Pressemelding

RedHill was granted the exclusive rights to promote Esomeprazole Strontium Delayed-Release (DR) Capsules to gastroenterologists in certain U.S. territories Esomeprazole Strontium DR Capsules 49.3 mg is an FDA-approved, proprietary, prescription proton pump inhibitor (PPI), indicated for adults for the treatment of gastroesophageal reflux disease (GERD) and other gastrointestinal (GI) conditions   RedHill expects to initiate the U.S. promotion of Esomeprazole Strontium  DR Capsules 49.3 mg  in the coming weeks   Esomeprazole Strontium  DR Capsules 49.3 mg  will be the third commercial GI product to be promoted by RedHill in the U.S.    RedHill's GI-focused sales force currently promotes two GI s

Brand Industrial Services Announces Agreement to Acquire Venko Groep BV16.8.2017 19:40Pressemelding

Complementary core strengths provide broader range of services for customers KENNESAW, GA, Aug. 16, 2017 (GLOBE NEWSWIRE) -- Brand Industrial Services, known as BrandSafway, has signed an agreement to acquire Venko Groep BV, a portfolio company of Mentha Capital. Venko will become a part of the Brand Energy & Infrastructure Services (Brand) group. "We are very pleased to announce the agreement with Venko," said Bill Hayes, President and CEO of BrandSafway. "Our combined customers in Europe will benefit from a broader range of solutions and greater depth of expertise in access, insulation and coatings. Bringing Venko's highly specialized knowledge in coatings to BrandSafway will provide the expertise we need to expand our services in the offshore market worldwide." Based in the Netherlands, with a focus on operations in the North Sea area, Venko is a leading offshore and onshore coatings maintenance provid

Abeona Therapeutics Announces Pivotal Expansion of ABO-102 Gene Therapy Clinical Trials in Sanfilippo Syndrome Type A16.8.2017 15:38Pressemelding

NEW YORK and CLEVELAND, Aug. 16, 2017 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (Nasdaq:ABEO), a leading clinical-stage biopharmaceutical company focused on developing novel gene therapies for life-threatening rare diseases, today announced the pivotal expansion of its gene therapy clinical trials for patients with MPS IIIA in the USA, Europe and Australia. "We have completed the necessary regulatory and ethical committee approvals and site initiations in Europe and Australia in order to accelerate enrollment," stated Juan Ruiz, M.D., Ph.D., Abeona's Chief Medical Officer. "We remain very encouraged by the improvements observed in clinically relevant biomarkers post-dosing of ABO-102, including durable reductions in heparan sulfate measured in the CNS, reduction of organ disease pathology, and signals of CNS improvement or stabilization at one-year follow-up in Cohort 1 subjects, and look forward to providing a more fulsome clinical update at important clinical

CallidusCloud Wins Eight Gold Stevies® in the 2017 International Business Awards16.8.2017 14:00Pressemelding

CallidusCloud Lead to Money suite recognized as Best B2B New Product of the Year. LeadRocket voted Best New Product or Service of the Year in the Software - Lead Generation Solution category. DUBLIN, Calif., Aug. 16, 2017 (GLOBE NEWSWIRE) -- Callidus Software Inc. (NASDAQ:CALD), a global leader in cloud-based sales, marketing, learning, and customer experience solutions, announced today that it was named the winner of eight Gold Stevie® awards in the 2017 International Business Awards. "The eight Stevie® awards earned highlight CallidusCloud's momentum, commitment to excellence, passion for innovation and customer orientation," said Leslie Stretch, president and CEO of CallidusCloud. "They also recognize the benefits that the Lead to Money suite, honored as the Best New Product in Business-to-Business, accrues to its customers in terms of enabling faster, bigger, and more profitable sales." CallidusCloud's Go

Ascom Myco and Koutio Médipôle optimize care communications and responsiveness16.8.2017 08:00Pressemelding

Ascom Holding AG / Ascom Myco and Koutio Médipôle optimize care communications and responsiveness . Processed and transmitted by Nasdaq Corporate Solutions. The issuer is solely responsible for the content of this announcement. Enabled by the Ascom Myco smart device, the new Koutio Médipôle is realizing improved care delivery through seamless information flow from the point of care to anywhere. BAAR, Switzerland, Aug. 16, 2017 (GLOBE NEWSWIRE) -- The new Koutio Médipôle hospital in the New Caledonian capital Nouméa, located in the southwest Pacific Ocean, has optimized patient care communications and responsiveness for the new 645-bed facility by deploying Ascom Myco Wi-Fi devices to support clinician teams and Ascom Myco Wi-Fi/GSM handsets, used across paramedic teams. The Ascom solution is seamlessly aligned with clinical workflow and applications (nurs

VistaJet Harnesses the Power of the American Eclipse to Offer Customers a Rare Viewing Opportunity15.8.2017 18:40Pressemelding

VistaJet invites customers to fly in parallel with an astronomical anomaly NEW YORK, Aug. 15, 2017 (GLOBE NEWSWIRE) -- VistaJet, the first and only global aviation company, will be offering customers the opportunity to experience and chase the American Solar Eclipse, appearing for the first time in 99 years on August 21, 2017. A photo accompanying this announcement is available at http://www.globenewswire.com/NewsRoom/AttachmentNg/c0c41d7d-7ad9-4a46-9d2d-dcc1148b4772 The coast-to-coast National Eclipse and astronomical phenomenon will be visible in the United States from approximately 10:15AM PST, with the sun disappearing behind the moon from the Oregon coast, passing through 14 states to South Carolina.  Without being in this 70-mile strip, Americans will not be able to see the sun eclipsed in totality. With unparalleled experience flying into and out of the hardest to reach destinations, VistaJet is offer

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

Besøk vårt presserom