Starpharma Holdings (ASX: SPL) is focused on the development of dendrimer nanotechnology for pharmaceutical, drug delivery and other applications. Products based on Starpharma’s dendrimer technology are already on the market as diagnostic elements and laboratory reagents through licence agreements.
Starpharma Holdings commences Phase 2 Study of VivaGel®
Starpharma Holdings (ASX:SPL,OTCQX:SPHRY) has commenced a phase 2 study of VivaGel® for the treatment of bacterial vaginosis, following receipt of ethics approval.
Dr Jackie Fairley, Chief Executive Officer of Starpharma, said: "The commencement of this study is an important step in the development of VivaGel®. Experts in this field have indicated there is a desperate need for new treatment options for BV.”
Starpharma announced in July 2010 that the US Food and Drug Administration (FDA) had accepted and cleared its investigational new drug application (IND) for the study. Clinical trial sites in the US will be initiated this week and will commence enrolment of participants immediately.
This phase of the clinical program will investigate the treatment of BV with a once daily for seven days treatment of VivaGel® and its findings will guide further investigation of its use in both treatment and suppression of recurrence.
BV is the most common vaginal infection worldwide, and the most common cause of vaginal irritation, discharge and malodor. It is particularly prevalent in the US, where it affects an estimated one-third of the adult female population. The condition is implicated in pelvic inflammatory disease and may also be associated with an increased risk of sexually transmitted infections, including HIV, and pre-term birth.
VivaGel® is also being developed as a topical microbicide for the prevention of HIV and genital herpes and as a condom coating in collaboration with SSL International. Other indications are also under assessment, including prevention of human papillomavirus, and other STIs.















