Starpharma to advance with phase III studies for VivaGel
Wednesday, 11 January, 2012
Starpharma has kicked off the year with a tick from the US Food and Drug Administration for its study design for phase III trials of VivaGel under the FDA’s Special Protocol Assessment scheme.
The agreement with the FDA confirms that the study design, endpoints, statistical analyses and other aspects of the trial are acceptable for achieving regulatory approval.
The company intends to undertake two phase III trials of VivaGen for the treatment of bacterial vaginosis (BV) this year, with results anticipated before the year’s end.
Assuming positive results, the company intends to partner in order to progress to marketing stage.
“Following our recent financing, we are also implementing various initiatives in collaboration with our CRO to expedite the trial timelines as much as possible,” said Dr Jackie Fairley, Chief Executive Officer of Starpharma.
Starpharma’s (ASX:SPL) is steady at $1.20.
Intense grief linked to higher risk of death for a decade
Researchers have found that bereaved people with persistent high levels of intense grief use more...
COVID vaccine candidate protects against multiple variants
By targeting features shared by a range of coronaviruses, the vaccine is designed to offer...
Stevia leaf extract has potential as an anticancer treatment
When fermented with bacteria isolated from banana leaves, stevia extract kills off pancreatic...
