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Company Plans to Commence New Pivotal, Randomized Phase 3 Study Evaluating T-Guard
® Versus Ruxolitinib in Patients with Grade III or IV Steroid-refractory Acute Graft-Versus-Host Disease in Second Half of 2021
Positive Results Expected to Support Both FDA and EMA Regulatory Submissions
NIJMEGEN, the Netherlands, July 19, 2021 (GLOBE NEWSWIRE) Xenikos B.V., a privately-held biotechnology company that develops innovative immunotherapies for treating patients with severe immune disease and post-transplant rejection, today announced that it has reached agreement with the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) on the design of its pivotal randomized Phase 3 clinical study (BMT CTN 2002) to evaluate T-Guard
Xenikos B.V.: Xenikos Announces T-Guard Phase 3 Clinical Update and Outlines 2021-2022 Corporate Objectives
Company Plans to Commence New Pivotal, Randomized Phase 3 Study Evaluating T-Guard Versus Ruxolitinib in Patients with Grade III or IV Steroid-refractory Acute Graft-Versus-Host Disease in Second Half of 2021
Positive Results Expected to Support Both FDA and EMA Regulatory Submissions
NIJMEGEN, the Netherlands, July 19, 2021 (GLOBE NEWSWIRE) Xenikos B.V., a privately-held biotechnology company that develops innovative immunotherapies for treating patients with severe immune disease and post-transplant rejection, today announced that it has reached agreement with the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) on the design of its pivotal randomized Phase 3 clinical study (BMT CTN 2002) to evaluate T-Guard
Moffitt Cancer Center presents new data from dozens of clinical research studies at ASCO
Moffitt Cancer Center, a national leader in cancer care and research and the only National Cancer Institute-designated Comprehensive Cancer Center based in Florida, is presenting new data from dozens of clinical research studies at this year s American Society of Clinical Oncology (ASCO) Annual Meeting, the world s largest clinical cancer research meeting. Moffitt investigators will lead 25 abstract presentations, five education sessions, two cancer-based panels and two clinical science symposia. The virtual meeting is June 4-8.
Highlights include:
Oral presentations:
Dr. Bijal Shah will present phase 2 results from the ZUMA-3 trial evaluating CAR T-cell therapy for adults with acute lymphoblastic leukemia, a challenging malignancy to treat in this patient population.
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TAMPA, Fla. - Moffitt Cancer Center, a national leader in cancer care and research and the only National Cancer Institute-designated Comprehensive Cancer Center based in Florida, is presenting new data from dozens of clinical research studies at this year s American Society of Clinical Oncology (ASCO) Annual Meeting, the world s largest clinical cancer research meeting. Moffitt investigators will lead 25 abstract presentations, five education sessions, two cancer-based panels and two clinical science symposia. The virtual meeting is June 4-8.
Highlights include:
Oral Presentations:
Dr. Bijal Shah will present phase 2 results from the ZUMA-3 trial evaluating CAR T-cell therapy for adults with acute lymphoblastic leukemia, a challenging malignancy to treat in this patient population.