Starpharma Holdings Limited announced the commencement of its phase 2 study of VivaGel for the prevention of bacterial vaginosis (BV), following receipt of ethics approval.

The prevention of BV is the second area of investigation of the VivaGel product for this condition.  In May 2011, Starpharma announced the positive results of its first study of VivaGel for the treatment of BV, which showed that the product successfully treated patients suffering the illness, with very high levels of patient acceptability.  Further discussions with the US Food and Drug Administration (FDA) and other regulators on the development of VivaGel for the treatment of BV will occur over the next few months, with phase 3 studies for BV treatment expected to commence in late 2011 or early 2012.

This new phase of the programme will investigate the ability of VivaGel to prevent recurrence of BV, which clinicians identify as a major unmet need.  The trial will be conducted in women with a prior history of recurrent BV, and the product will be used every second day.
 
The study will be conducted under an investigational new drug application (IND) at sites in US and will enrol approximately 200 women.  Clinical trial sites have been fully assessed, and the first patient is expected to be enrolled later this month, following final initiation of sites. The primary objective of the study is to determine the efficacy of two strengths of VivaGel® (1% and 3%) compared with a placebo gel in preventing recurrence of BV.  Whilst the duration of use of the product in this study is 16 weeks, it is intended that women would use the product as a long-term prevention tool if proven effective.

Dr Jackie Fairley, chief executive officer of Starpharma, said: "There are currently very few proven options for women who wish to prevent recurrence of BV.  Clinical experts in this field have repeatedly expressed the need for products to prevent the recurrence of this condition and so the commencement of this program is an important step in the development of VivaGel® and the management of the condition.”
 
"In addition to the obvious unmet market need for the recurrence indication, we were very encouraged by the results obtained in our phase 2 BV treatment trial of VivaGel reported in May, and the implications of these results for recurrence.  These included high rates of cure and rapid resolution of symptoms together with excellent patient acceptability”, she said.

BV is caused by a disruption to the delicate balance of the vaginal bacteria, so that the bacteria that help maintain a normal healthy vagina are reduced and harmful bacteria overgrow.  The symptoms of BV include vaginal irritation, discharge and odour that are unpleasant and disrupt and interfere with a woman’s relationships and general quality of life.  Relapse, or recurrence, of BV is extremely common following treatment with existing antibiotics, and long-term use of these existing products is not recommended.

BV is associated with serious health consequences such as pelvic inflammatory disease and pre-term births.  Several studies have also found an association between BV and acquisition of HIV, with one study indicating that more than 30% of HIV infections in women could be prevented if BV was successfully treated.  In addition, a recent study showed men were three times more likely to contract HIV from their female partners if the women also had BV in the three months before the men became infected.
 
VivaGel is also being developed as a topical microbicide for the prevention of HIV and genital herpes and as a condom coating.  Prevention of human papillomavirus is also under assessment.