GSK publishes positive phase III Synflorix data

GlaxoSmithKline (GSK) has announced the publication of positive phase III clinical trial data showing that its paediatric candidate vaccine Synflorix has the potential to offer enhanced protection against life-threatening pneumococcal diseases.

The company presented the clinical trial data at the international symposium on Pneumococci and Pneumococcal Disease held in Reykjavik, where it said its vaccine candidate has broader coverage against invasive disease than existing paediatric vaccinations, including pneumococcal strains 1, 5 and 7F.
Synflorix protects against Streptococcus pneumoniae, bacteria responsible for diseases including sepsis and meningitis.

GSK said that, depending on the relative importance of the 1, 5 and 7F serotypes in respective regions worldwide, its candidate vaccine could potentially prevent more invasive pneumococcal disease than the 7-valent vaccine.

Jean Stephenne, president of biologicals at GSK, said: “The data presented today are extremely encouraging and represent a major step forward to a pneumococcal conjugate vaccine formulation specifically designed to address the global epidemiology of pneumococcal disease in both developed and developing countries.”

GSK noted that Synflorix was filed for regulatory review with the European Medicines Agency (EMEA) in January 2008, while regulatory filings were made in parallel in the international region, with further submissions continuing.

Earlier this year, the company said that EMEA acceptance of its regulatory submission marked a key step towards the introduction of the vaccine.