VivaGel(R) Demonstrates Efficacy in Bacterial VaginosisBy Starpharma, PRNE
Sunday, May 22, 2011
SYDNEY, May 23, 2011 -
Starpharma Holdings Limited (ASX: SPL, OTCQX: SPHRY) today announced
successful results of a major phase 2 clinical study that demonstrated
efficacy of VivaGel(R) for the treatment of bacterial vaginosis (BV).
- VivaGel(R) meets primary endpoint, demonstrating significant efficacy for treatment of BV - VivaGel(R) expected to avoid many shortcomings of existing therapies - Trial results support new patent filing which extends VivaGel(R) protection to at least 2032 - Planning underway for Phase 3 trials for VivaGel(R) for BV treatment - BV prevention trial of VivaGel(R) to commence Q3 2011 - Addressable global market for BV treatment and prevention potentially exceeds $1B
VivaGel(R) meets primary endpoint, demonstrating significant efficacy for
treatment of BV
The study showed that treatment with VivaGel(R) (containing 1% of the
active, SPL7013), once daily for seven days, resulted in 74% of patients
achieving Clinical Cure of BV 2 to 5 days after completion of therapy
compared with just 22% in the placebo group (P=0.0002).
Moreover, 2 to 3 weeks after completion of therapy, 46% of patients
achieved Clinical Cure of BV compared with just 12% for the placebo (P=0.006)
indicating that VivaGel(R) provided lasting cure in a significant proportion
of the women. Both results were highly statistically significant and cure at
both time points is considered by clinicians to be important in the clinical
management of BV.
The main symptoms of BV are unpleasant vaginal discharge and odour. In
Starpharma's study, vaginal BV discharge as assessed by the investigator was
cured following treatment in 89% of the VivaGel(R) treated patients.
Unpleasant vaginal odour was cured in 78% of the VivaGel(R) treated patients.
Dr Jackie Fairley, Chief Executive Officer of Starpharma, said:
"Starpharma's objective is to develop an efficacious BV product that avoids
the side-effects and other shortcomings of conventional antibiotics."
"This Phase 2 study was a crucial test of the product and these exciting
results confirm the significant commercial potential of VivaGel(R) for BV. As
well as the great outcome for the acute treatment opportunity, we are also
very encouraged by the implication of these results for the additional
application of VivaGel(R) for prevention of BV recurrence."
"It is particularly pleasing to see such high rates of resolution of
symptoms and excellent patient acceptability", she said.
Existing treatments for BV, such as the conventional antibiotics
metronidazole and clindamycin, have published Clinical Cure rates of between
35% and 65% when assessed 2-3 weeks after completion of therapy.
Unfortunately, existing products have significant shortcomings in terms of
side-effects or tolerability, high levels of antibiotic resistance and in
some cases incompatibility with condoms.
In contrast, whist having comparable efficacy, VivaGel(R) is well
tolerated, is not absorbed (and so is free from systemic effects), can be
used with condoms, and has the real potential to be used for prolonged
periods to prevent recurrence of BV.
Clinical Cure 2 to 3 weeks after completion of treatment is currently the
US FDA's preferred endpoint for assessing cure of BV. In addition to cure of
BV achieved with VivaGel(R) at that time, acceptability of the product was
very high with 83% of patients using 1% VivaGel(R) extremely satisfied, very
satisfied or satisfied with the product when taking all aspects of the
treatment into account, compared with just 35% of patients using the placebo.
Professor George Kinghorn, of the Department of Genitourinary Medicine at
the Royal Hallamshire Hospital, Sheffield, UK, a leading expert in BV and
Medical Advisor to Starpharma on this Phase 2 study, commented: "These
significant efficacy results are very promising and indicate that VivaGel(R)
is a potentially useful alternative acute treatment for BV that is different
from the systemic and topical antibiotic agents that are the current mainstay
The study was a double-blind, randomized, placebo controlled, dose
ranging Phase 2 study and was conducted at sites in the US under an
Investigational New Drug (IND) application with the US FDA. The study
enrolled 132 women who were randomized to receive VivaGel(R) (0.5%, 1% or 3%
SPL7013), or placebo. The incidence of adverse events, including
genitourinary adverse events, was similar across all placebo gel and
VivaGel(R) groups. No severe (grade 3) adverse events were observed in the
VivaGel(R) groups. Two severe adverse events were observed in the placebo.
Additional details and results from the study are provided in the
Appendix to this announcement.
Addressable global market for BV treatment and prevention potentially
The global market for topical BV treatments alone is estimated at
approximately US$350M. Starpharma's modeling suggests the addressable global
market for prevention of recurrence of BV is potentially in excess of $1
billion, due to the long term usage associated with such a product.
Trial results support new patent filing which extends VivaGel(R)
protection to at least 2032
On the basis of the data from this phase 2 study, Starpharma has filed a
new patent application relating to BV that will, once granted, expand and
extend patent protection for VivaGel(R) to at least 2032.
Planning underway for Phase 3 trials for VivaGel(R) for BV treatment
Based on the results of this phase 2 study, Starpharma will undertake
further discussions with regulatory authorities, with a view to initiating
phase 3 registration trials of VivaGel(R) for the treatment of BV in late
2011 or early 2012.
BV prevention trial of VivaGel(R) to commence Q3 2011
As previously announced Starpharma is also well advanced in its planning
of studies to determine the efficacy of VivaGel(R) for this second BV
indication and expects to commence this trial in Q3 2011. The very high
early cure rate observed in this study is an important observation that is
highly relevant to and supportive of the application of VivaGel(R) for
prevention of BV recurrence.
About Bacterial Vaginosis
BV is the most common vaginal infection worldwide and is particularly
prevalent in the US, where it affects an estimated one-third of the adult
female population. Similar to imbalances between "good" and "bad" bacteria in
the gut, an imbalance in the vaginal microbiota between good bacteria - which
help maintain a normal healthy vagina - and harmful bacteria, leads to BV
with symptoms including vaginal irritation, discharge and odour that are
unpleasant and disrupt and interfere with a woman's relationships and general
quality of life. The condition also has more serious consequences, being
implicated in pelvic inflammatory disease and associated with an increased
risk of pre-term birth. BV also significantly increases the risk of some
sexually transmitted infections, including HIV.
Several studies have 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. Therefore, treatment of BV
with VivaGel(R) could have a positive indirect impact in reducing HIV
Other Applications of VivaGel(R)
VivaGel(R) 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.
For a copy of the clinical appendix please go to
For Further Information: Media: Buchan Consulting Rebecca Wilson Mob: +61-417-382-391 firstname.lastname@example.org Starpharma: Dr Jackie Fairley Chief Executive Officer +61-3-8532-2704 Ben Rogers Company Secretary +61-3-8532-2702 email@example.com www.starpharma.com
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