Xenikos

15 articles with Xenikos

• Xenikos Secures €40 Million in Convertible Debt Financing, Veloxis Pharmaceuticals Joins as Strategic Investor

  9/8/2021

  Xenikos B.V., a clinical-stage biopharmaceutical company currently developing a novel therapy for treating immune related disorders, announced the closing of €40 million in convertible debt consisting of two equal tranches of €20 million.

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  Clinical Catch-Up: July 19-23

  7/26/2021

  It was another busy week for clinical trial updates. Here’s a look at some including Mesoblast Limited, CytoDyn, Magenta Therapeutics and more.

• Xenikos Announces T-Guard® Phase 3 Clinical Update and Outlines 2021-2022 Corporate Objectives

  7/19/2021

  Xenikos B.V. announced that it has reached agreement with the US Food and Drug Administration and the European Medicines Agency on the design of its pivotal randomized Phase 3 clinical study to evaluate T-Guard® versus ruxolitinib for the treatment of patients with Grade III or IV steroid-refractory acute graft-versus-host disease following allogeneic hematopoietic stem cell transplant.

• Xenikos announces first patient receives T-Guard® for steroid-refractory acute GVHD in pivotal U.S.-based Phase 3 trial

  12/18/2019

  Xenikos B.V. announced that the first patient has been treated in their U.S.-based Phase 3 registration trial designed to evaluate the use of T-Guard for treating steroid-refractory acute graft-versus-host disease in patients following allogeneic stem cell transplantation.

• Xenikos presents promising new data from expanded access program (EAP) using T-Guard® to treat steroid-refractory acute GVHD at ASH Annual Meeting

  12/9/2019

  The Dutch company Xenikos B.V., which develops innovative immunotherapies for treating patients with severe immune disease and post-transplant rejection, reports data from an expanded access program using T-Guard to treat steroid-refractory acute graft-versus-host disease in patients following allogeneic stem cell transplantation.

• Xenikos appoints Stanley Musial as Chief Financial Officer and Chief Business Officer

  12/2/2019

  Experienced financial leader joins Xenikos as they enter the final stage of clinical development of T-Guard®

• Xenikos receives FDA Fast Track designation for T-Guard® for treating steroid-refractory acute graft-versus-host disease

  10/14/2019

  The Dutch company Xenikos B.V. announced that the U.S. Food and Drug Administration has granted Fast Track designation to T-Guard, Xenikos’ flagship product designed to treat steroid-refractory acute graft-versus-host disease in patients following allogeneic stem cell transplantation.

• Xenikos announces IND clearance by the FDA for a pivotal Phase 3 trial using T-Guard® for treating steroid-refractory acute GVHD

  6/11/2019

  The Dutch company Xenikos B.V. announced that the U.S. Food and Drug Administration has approved an investigational new drug application to initiate a U.S.-based clinical Phase 3 registration trial in order to test the efficacy of T-Guard for treating steroid-refractory acute graft-versus-host disease in patients following allogeneic stem cell transplantation.

• Xenikos partners with the Blood and Marrow Transplant Clinical Trials Network (BMT CTN) to conduct a U.S.-based Phase 3 trial to test T-Guard® in acute graft-versus-host disease

  12/20/2018

  Study will be conducted at up to 20 leading transplant centers in the U.S.

• Final results from T-Guard® Phase 1/2 trial in steroid-resistant acute graft-versus-host disease published online in peer-reviewed journal Biology of Blood and Marrow Transplantation

  11/16/2018

  Overall response rate at 28 days of 60%, complete response rate of 50%

• Xenikos Announces Data From Phase I/II Trial With T-Guard for Treatment of Steroid-Resistant Acute GVHD Presented at ASH Annual Meeting

  12/11/2017

  Treatment with a short course of T-Guard was generally well tolerated with no significant infusion reactions.

• Xenikos Appoints Eric Van Hooren As Chief Development Officer To Drive Forward T-Guardtm Clinical Development Program

  11/2/2016

• Xenikos To Participate In 3PBio Forum Technology Transfer Panel On September 29 At BIOSPAIN 2016

  9/20/2016

• Xenikos: Last Patient Treated In Phase 1/2 Trial With T-Guard In Acute Graft-Versus-Host Disease

  9/15/2016

• Xenikos To Introduce Immunotherapy T-Guard To Potential Pharmaceutical Partners At BIO International Convention 2016

  5/24/2016