FDA Grants Special Protocol Assessment (SPA) Agreement for Starpharma Phase
3 Recurrent BV Trial
MELBOURNE, Australia -- July 14, 2014
Starpharma Holdings Ltd (ASX:SPL) (OTCQX:SPHRY) today announced that the US
Food and Drug Administration (FDA) has granted Special Protocol Assessment
(SPA) agreement on the design and planned analyses of the phase 3 clinical
studies of the VivaGel^® bacterial vaginosis (BV) product for the prevention
of recurrent BV.
The favourable SPA outcome provides a binding agreement from the FDA that the
phase 3 clinical study design, endpoints, statistical analyses and other
aspects of the planned studies adequately address objectives in support of a
US regulatory submission for approval of the product.
The granting of SPA agreement by the FDA follows the earlier agreement of the
European Medicines Agency (EMA) on the design of the phase 3 studies.
Starpharma will now commence its two pivotal phase 3 clinical trials of
VivaGel^® for the prevention of recurrent BV at sites in North America, Europe
The two phase 3, double-blind, randomised, placebo-controlled trials will be
identical in design and will compare the rate of BV recurrence in women using
VivaGel^® to the rate of recurrence in women using a placebo gel during a 16
week treatment period. Approximately 600 women will be recruited into each
Starpharma Chief Executive Officer, Dr Jackie Fairley, said: “Receiving
agreement on the SPA is an important and very positive development as it
effectively eliminates the US regulatory risk associated with clinical
development, by specifying upfront the FDA’s agreed trial design. This
significantly reduces overall development risk for VivaGel^®. SPA agreement
from the FDA is protected by US law and gives Starpharma certainty and
confidence that the studies will support a regulatory submission for the
approval of VivaGel^® for the prevention of recurrent BV in the US.”
VivaGel^® (SPL7013, astodrimer sodium) is a non-antibiotic agent formulated as
a vaginally applied gel for prevention of BV recurrence. It is also being
developed for the management of BV symptoms, which include unpleasant vaginal
odour and discharge, and regulatory submissions to support the symptomatic
relief indication are also planned for 2HCY14.
There are no approved products for the prevention of recurrent BV and so
VivaGel^® will be a world-first therapy for this troublesome condition.
Bacterial vaginosis affects around 1 in 3 women and recurs in approximately 50
per cent of women within 12 months.
In the previous exploratory phase 2 clinical trial, more than 80 per cent of
women receiving 1% VivaGel^® remained BV-free at 16 weeks and the product also
provided protection against the occurrence of BV symptoms. Formal market
research with both patients and clinicians and from Key Opinion Leaders
strongly supports the demand for a product such as VivaGel^® in the management
Bacterial vaginosis is the most common cause of vaginal infection for women of
childbearing age affecting around 30% of women in the US. It is a highly
recurrent condition with 50-60% of sufferers having it recurrently. Bacterial
vaginosis is caused by an imbalance of naturally occurring bacterial flora
(the usual bacteria found in a woman's vagina). Smoking and the use of some
hygiene products are linked to a higher risk of developing BV.
BV results in unpleasant and embarrassing symptoms such as odour and vaginal
discharge. It has been linked to still birth, pregnancy complications, pelvic
inflammatory disease, and lower rates of fertility. It also is associated with
increased susceptibility of women to HIV and other STIs, and an increased risk
of transmission of HIV from women to men.
Rebecca Wilson, +61 417 382 391
Dr Jackie Fairley, +61 3 8532 2704
Chief Executive Officer
CFO and Company Secretary
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