15 articles with Xenikos
Xenikos Secures €40 Million in Convertible Debt Financing, Veloxis Pharmaceuticals Joins as Strategic Investor
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.
7/26/2021It was another busy week for clinical trial updates. Here’s a look at some including Mesoblast Limited, CytoDyn, Magenta Therapeutics and more.
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
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
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.
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
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
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
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
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
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
Xenikos To Introduce Immunotherapy T-Guard To Potential Pharmaceutical Partners At BIO International Convention 2016