A candidate malaria vaccine developed by GlaxoSmithKline Plc has shown efficacy in a Phase 3 trial in infants in Africa. But the results were less robust than expected. Researchers involved in the project said they will continue to analyse the data to clarify how the vaccine might play a role in overall malaria prevention.
After a trial delay that triggered a corporate restructuring, Pharming Group NV of the Netherlands has now reported positive clinical data for Ruconest, its lead drug for hereditary angioedema (HAE). A US regulatory filing is expected in the 2013 first half.
Addex Therapeutics Ltd of Switzerland has reported top-line data from an early trial of an allosteric modulator drug in patients with schizophrenia. The data show that the compound, ADX71149, met its primary objectives of safety and tolerability.
The Lancet has published two Phase 3 studies of the Sanofi SA multiple sclerosis drug, Lemtrada (alemtuzumab), which show that the antibody significantly reduced relapse rates of the disease compared with the standard of care – Rebif (interferon beta 1a).
Clavis Pharma ASA expects to report top-line results before the end of 2012 from a pivotal trial of its personalized therapy for patients with pancreatic cancer – one of the most difficult-to-treat cancers.
Eli Lilly and Company said that three Phase 3 studies of dulaglutide, its glucagon-like peptide 1 (GLP-1) treatment for Type 2 diabetes, met their primary endpoints and showed superiority in reducing blood sugar levels compared with exenatide and two other drugs.
Wilex AG’s lead cancer product – an antibody for renal cell carcinoma – has failed in a Phase 3 trial. The antibody, Rencarex (girentuximab), was already partnered and had been given fast track review status by the US Food and Drug Administration.
The non-profit drug developer, Aeras, has signed an agreement with GlaxoSmithKline Vaccines SA to advance the clinical development of a new vaccine against tuberculosis. A Phase 2b trial of the vaccine is scheduled to start in Kenya, India and South Africa.
Affimed Therapeutics AG of Germany has raised €15.5 million in venture capital to finance the early clinical testing of two bispecific antibody products developed to treat lymphomas. The Series D funding is being lead by existing investors.
ArGEN-X BV of the Netherlands has taken the unusual step of out-licensing its lead preclinical antibody compound to a Shanghai-based company which will take it into human studies in China and thereafter develop it.