A Phase 3 trial of the Bavarian Nordic A/S candidate vaccine for prostate cancer, Prostvac, has been declared futile based on the results of a preplanned interim analysis. The trial’s independent data monitoring committee is recommending the study be discontinued.
A Phase 3 trial of a candidate gene therapy for retinal disorder has been highlighted in The Lancet as a possible standard for future trials of genetic medicines. The trial was conducted by Spark Therapeutics Inc whose therapy, voretigene neparvovec, is under review at the US Food and Drug Administration.
Phase 3 trial results of canakinumab (Ilaris), a monoclonal antibody that targets interleukin 1 beta (IL-1 beta), have shown a significant 15% reduction of major cardiovascular events in people with a prior heart attack and inflammatory atherosclerosis.
Amgen Inc said that its licensed drug, Kyprolis (carfilzomib), produced a better survival benefit in a Phase 3 trial of patients with relapsed or refractory multiple myeloma than Velcade (bortezomib). The trial results were published in The Lancet Oncology on 23 August.
Regeneron Pharmaceuticals Inc has stopped development of suptavumab, a candidate antibody for the treatment of respiratory syncytial virus (RSV) in infants following the failure of a Phase 3 trial to prevent medically- attended infections.
A Phase 2a study of a drug developed by Galapagos NV for patients with idiopathic pulmonary fibrosis has halted the progression of the disease in a randomised, placebo-controlled study. Galapagos said it is making plans for a late-stage trial.
Results from a Phase 3 trial of emicizumab, an experimental treatment for haemophilia A, were published online in the New England Journal of Medicine on 10 July. They showed the treatment achieved a clinically meaningful reduction in bleeding episodes in patients with antibodies to factor VIII replacement therapy.
Shire Plc is advancing a candidate gene therapy acquired from its 2016 purchase of Baxalta, with plans to take the product into a first human trial in patients with haemophilia A. The product is a factor VIII gene therapy delivered in an adeno-associated virus (AAV) vector.
Three multiple myeloma studies in which Merck & Co’s checkpoint inhibitor Keytruda (pembrolizumab) was being investigated in combination with drugs produced by Celgene Corp have been stopped following patient deaths, Merck announced on 5 July.
The term biopsy has traditionally been associated with the examination of tissue from a patient in order to detect the presence of disease. Tissue samples can be taken from the bone marrow, or organs such as the bladder, lung or liver, using procedures of varying complexity from the insertion of a needle into the skin, to surgery.