Clinical Research

TiGenix reports on cell therapy trial in RA

Country
Belgium

TiGenix NV has reported that a Phase 2a study of its allogeneic stem cell therapy in patients with refractory rheumatoid arthritis had positive six-month safety data. The trial enrolled patients who had failed to respond to at least two biologic therapies.

T-cell therapy works in ALL

Country
United States

A revolutionary T-cell immunotherapy developed by scientists at the University of Pennsylvania in the US has demonstrated a positive result in acute lymphoblastic leukaemia (ALL), an aggressive form of childhood cancer. The results of the treatment, which was administered to two patients aged seven and 10, are scheduled to appear in the 18 April 2013 edition of The New England Journal of Medicine. A summary of the study was released early on 25 March.

CureVac initiates new study of mRNA vaccine

CureVac GmbH has initiated a Phase 2b trial of its messenger RNA vaccine, a new treatment modality, in patients with castration-resistant prostate cancer. The trial will enrol up to 200 patients in eight European countries.

Merck Serono glioblastoma trial fails

Country
Germany

Merck Serono said that a Phase 3 trial of its integrin inhibitor, cilengitide, for the treatment of glioblastoma did not meet its primary endpoint of significantly increasing overall survival when added to the current standard of care, temozolomide and radiotherapy.

Clavis expects AML results in Q1

Country
Norway

Clavis Pharma ASA expects to report top-line Phase 3 results for its compound for acute myeloid leukaemia (AML) by the end of the first quarter. The compound, elacytarabine, is a derivative of cytarabine- the licensed AML chemotherapy.

Ablynx reports further efficacy data for ALX-0061

Country
Belgium

Ablynx NV has reported further efficacy data for its early-stage rheumatoid arthritis drug ALX-0061 which showed that up to 75% of patients achieved remission as defined by the DAS28 measure of disease activity at week 24 in a Phase 2 study.

Lilly stops RA programme for tabalumab

Country
United States

Eli Lilly and Company has decided to stop development of the monoclonal antibody, tabalumab, in rheumatoid arthritis due to lack of efficacy. But it will continue to investigate the same drug as a possible treatment for systemic lupus erythematosus.

Clinical Trials: round-up of recent advances and setbacks

Country
Switzerland

The Roche Group said its candidate antibody for haematological cancers, obinutuzumab, met its primary endpoint in the first stage of a Phase 3 trial and will now move on to be compared directly with MabThera/Rituxan (rituximab), the standard of care for leukaemias and lymphomas.

Phase 3 Aranesp trial fails to meet endpoint

Country
United States

The licensed Amgen Inc medicine Aranesp (darbepoetin alfa) failed to meet its primary endpoint in a Phase 3 trial that was investigating the drug in a new heart failure indication. There were no new safety findings identified in the study.

ArGEN-X starts cancer study; broadens alliance with Shire

Country
Netherlands

ArGEN-X BV has announced the initiation of a Phase 1b clinical study in cancer patients of a new antibody targeting CD70, a member of the tumour necrosis factor superfamily. The company also announced an expansion of its discovery alliance with Shire Plc.