Enox Biopharma, Ltd., a leader in nitric oxide delivery technology for the prevention of hospital acquired infections announced today the enrollment of the first subjects in a phase 1a/1b study for the evaluation of the safety and tolerability of Nitric Oxide (NO) impregnated urinary catheters. The study primary aim of this first in man study is to assess the safety and tolerability of NO-charged Foley catheters left in place for 7 to 14 days following surgical removal of the prostate. This two-arm study will also measure and compare the biofilm formation on the surface of NO charged versus non-NO charged Foley catheters as well as measure the presence of bacterium in the urine of subjects managed with the different catheter types.
Sativex (nabiximols) is derived from cannabis and usually used to treat the symptoms of multiple sclerosis (MS). This trial was testing the drug for the treatment of patients with advanced cancer where opioid therapy does not adequately reduce their pain, but it did not demonstrate a statistically significant difference from placebo.
Sanofi and Regeneron Pharmaceuticals have reported positive results from the interim analysis of a dose-ranging Phase IIb trial of dupilumab, a fully-human monoclonal antibody, in adult patients with uncontrolled moderate-to-severe asthma.
TxCell undertaking one of largest ever controlled studies for a personalized T cell immunotherapy product .
Top line results of this study are expected end 2016/early 2017.
TxCell SA (FR0010127662 – TXCL), a biotechnology company developing novel and innovative, cost-effective personalized T cell immunotherapies using antigen specific regulatory T-cells (Ag-Tregs) for severe chronic inflammatory and autoimmune diseases, announces today that it has enrolled the first patient in its phase IIb clinical trial of its lead product Ovasave(R) in refractory Crohn’s disease. TxCell has received approval for this multi-center, multinational trial from the regulatory authorities in all six European countries in which the trial will be performed. Top line results of this study are expected at the end of 2016 to early 2017.
US-based Sarepta Therapeutics has started dosing patients in a clinical trial of its lead exon-skipping therapeutic candidate eteplirsen to treat Duchenne muscular dystrophy (DMD).
The news is a remarkable turnaround for the drug, which had looked doomed to failure just a few months ago. In January this year, GlaxoSmithKline returned the rights to the drug following failure in Phase 3 trials.