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FlandersBio informs you about important regional and national life sciences news. Send us your news. If your news is of interest to the life sciences community, we will post it on our website.

FlandersBio informeert u over belangrijk nieuws op het vlak van de biowetenschappen. Bezorg ons jouw nieuwtjes. Als het interessant is voor de sector, zullen wij het op onze website plaatsen.

Oncurious NV Announces FDA Acceptance of Investigational New Drug (IND) Application for a Phase I/IIa Study with TB-403 for the Treatment of Pediatric Brain Tumors

07.01.2016

Oncurious NV, an oncology company focused on the development of innovative medicines for the treatment of pediatric tumors, today announces that the FDA has completed the safety review of its Investigational New Drug (IND) Application and have concluded that the proposed pediatric clinical investigation can proceed. The Investigational New Drug (IND) Application is for a Phase I/IIa study that will evaluate the efficacy and safety of TB-403 for the treatment of Relapsed or Refractory Medulloblastoma. This is a rare, life-threatening brain tumor that mainly affect children. read more

GENTICEL TO EVALUATE ROCHE MOLECULAR SYSTEMS’ COBAS® HPV TEST IN PREPARATION FOR PHASE 3 PROGRAM OF GTL001

07.01.2016

Genticel (Euronext Paris & Brussels: FR00011790542 – GTCL), a clinical-stage biotechnology company and developer of innovative immunotherapies to prevent cancers caused by the human papillomavirus (HPV), today announces that the Company has signed an agreement with Roche Molecular Systems Inc. to evaluate Roche’s cobas® HPV Test in preparation for the planned phase 3 trial of GTL001, Genticel’s most advanced therapeutic vaccine candidate against HPV 16/18 infections. read more

argenx announces initial results from a Phase 1 single ascending dose study of ARGX-113 in healthy volunteers

06.01.2016

argenx (Euronext Brussels: ARGX), a clinical-stage biopharmaceutical company focused on creating and developing differentiated therapeutic antibodies for the treatment of cancer and severe autoimmune diseases, today announced that it has completed the dose-escalation part of a Phase 1 study of ARGX-113. Initial results show the compound to be safe and well-tolerated across all doses in healthy volunteers. read more

Celyad completes 30-day safety follow-up of first patient of second cohort in NKG2D CAR T-Cell Phase I Trial

05.01.2016

Celyad (Euronext Brussels and Paris, and NASDAQ: CYAD), a leader in the discovery and development of engineered cell therapies, with clinical programs in cardiovascular disease and immuno-oncology, today announced the completion of the 30-day safety follow-up of the first patient enrolled in the second cohort in the Phase I clinical trial evaluating the safety and feasibility of its NKG2D CAR T-cell therapy, in cancer patients suffering from acute myeloid leukemia (AML) or multiple myeloma (MM). read more

Celyad receives clearance from the US FDA on its CHART-2 Phase III IND

21.12.2015

Celyad (Euronext Brussels and Paris, and NASDAQ: CYAD), a leader in the discovery and development of engineered cell therapies, with clinical programs in cardiovascular disease and immuno-oncology, today announced that the U.S. Food and Drug Administration (FDA) has authorized the Company’s Investigational New Drug (IND) application to proceed thus allowing for the clinical testing of Celyad’s lead cardiology candidate (C-Cure cardiopoietic cells) delivered via the proprietary catheter (C-Cathez) in the Phase III Heart Failure Trial (CHART-2) in the US. read more

Celyad announces the publication of its CHART-1 trial design methods paper in the European Journal of Heart Failure

16.12.2015

Celyad (Euronext Brussels and Paris, and NASDAQ: CYAD), a leader in the discovery and development of engineered cell therapies, with clinical programs in cardiovascular disease and immuno-oncology, today announces that a methods paper on the Congestive Heart Failure Cardiopoietic Regenerative Therapy (CHART-1) clinical trial design has been published in the European Journal of Heart Failure (EJHF 2015). read more

Bone Therapeutics completes recruitment of the first half of patients in ALLOB® Phase IIA spinal fusion trial

15.12.2015

BONE THERAPEUTICS (Euronext Brussels and Paris: BOTHE), the bone cell therapy company addressing high unmet medical needs in the field of bone fracture repair and bone fracture prevention, today announces it has successfully completed recruitment of the second cohort of four patients in its ALLOB® Phase IIA spinal fusion trial without any safety concerns. Recruitment for this trial remains on track at the midpoint of the trial, with eight out of a total of 16 patients treated. read more

Complix Advances Novel Biospecific Immunotherapeutic CMX-02 - Enters Agreement with Selexis

14.12.2015

Complix NV, a biopharmaceutical company developing a pipeline of transformative protein therapeutics, called Alphabodies™, for the treatment of cancer and severe autoimmune diseases, announces that it is advancing the development of CMX-02, a potential treatment of severe autoimmune disease. CMX-02 is a bispecific Alphabody-antibody fusion protein that simultaneously targets TNFα and IL-23. The Company has entered into an agreement with Switzerland-based Selexis SA to enable the production of this novel drug candidate. read more

Filgotinib meets primary endpoint in phase 2 study in patients with moderate to severe Crohn's disease

08.12.2015

Galapagos NV (Euronext & NASDAQ: GLPG) announced today that 200 mg filgotinib is shown to be effective and safe as once-daily, oral induction treatment in moderate to severe Crohn's disease, based on the FITZROY phase 2 study at the 10-week interim analysis. The study achieved the primary endpoint of clinical remission: the percentage of patients achieving a CDAI score lower than 150 was significantly higher in patients treated with filgotinib versus patients receiving placebo. Filgotinib was shown to be well tolerated in the FITZROY study, strengthening its favorable safety profile. read more

argenx to host workshop and webcast announcing topline clinical TCL data and preclinical AML data from ARGX-110 program

07.12.2015

argenx (Euronext Brussels: ARGX), a clinical-stage biopharmaceutical company focused on creating and developing differentiated therapeutic antibodies for the treatment of cancer and severe autoimmune diseases, today announced that it will host a workshop and webcast to discuss new ARGX-110 data, in conjunction with the American Society of Hematology (ASH) Annual Meeting. The data on ARGX-110, a novel anti-CD70 therapeutic antibody, include topline clinical results in T-cell lymphoma (TCL) and preclinical data in acute myelogenous leukemia (AML). read more

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