MELBOURNE, Australia,
Aug. 15, 2011 /PRNewswire-Asia/ --
Starpharma Holdings Limited (ASX: SPL, OTCQX: SPHRY) today
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 program 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 enroll 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.
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.
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.
A copy of the Clinical Trial Summary is attached as Appendix
A.
ABOUT STARPHARMA
Starpharma Holdings Limited (ASX:SPL, OTCQX:SPHRY) is a world
leader in the development of dendrimer technology for
pharmaceutical, life-science and other applications. SPL has two
operating companies, Starpharma Pty Ltd in Melbourne, Australia and DNT, Inc in the
USA. Products based on SPL's
dendrimer technology are already on the market in the form of
diagnostic elements and laboratory reagents through licence
arrangements with partners including Siemens and Merck KGaA.
The Company's lead pharmaceutical development product is
VivaGel® (SPL7013 Gel), a vaginal microbicide designed to prevent
the transmission of STIs, including HIV, genital herpes and
bacterial vaginosis. Starpharma has a licence agreement with
Durex® condom manufacturer Reckitt Benckiser to develop a VivaGel®
-coated condom, and a licence agreement with Okamoto Industries Inc
in relation to the VivaGel® -coated condom for the Japanese market.
Okamoto is the market leader for condoms sold in Japan, the world's second largest condom
market.
Starpharma also has agreements in place with Lilly, Elanco,
Stiefel Laboratories (a GSK Company), and Siemens Healthcare as
well as many research collaborations with some of the world's
leading organisations in the fields of pharmaceuticals, drug
delivery, cosmetics and agrochemicals.
Dendrimer: A type of precisely-defined, branched
nanoparticle. Dendrimers have applications in the medical,
electronics, chemicals and materials industries.
American Depositary Receipts (ADRs): Starpharma's ADRs
trade under the code SPHRY (CUSIP number 855563102).
Each Starpharma ADR is equivalent to 10 ordinary shares of
Starpharma as traded on the Australian Securities Exchange (ASX).
Starpharma's ADRs are listed on International OTCQX, a premium
market tier in the U.S. for international exchange-listed
companies, operated by OTC Markets Group Inc.
(www.otcmarkets.com).
Forward Looking Statements
This document contains certain forward-looking statements,
relating to Starpharma's business, which can be
identified by the use of forward-looking terminology such as
"promising",
"plans",
"anticipated",
"will",
"project",
"believe",
"forecast",
"expected",
"estimated",
"targeting",
"aiming", "set
to", "potential",
"seeking to",
"goal", "could
provide", "intends",
"is being developed",
"could be", "on
track", or similar expressions, or by express or
implied discussions regarding potential filings or marketing
approvals, or potential future sales of product candidates. Such
forward-looking statements involve known and unknown risks,
uncertainties and other factors that may cause actual results to be
materially different from any future results, performance or
achievements expressed or implied by such statements. There can be
no assurance that any existing or future regulatory filings will
satisfy the FDA's and other health
authorities' requirements regarding any one or more
product candidates nor can there be any assurance that such product
candidates will be approved by any health authorities for sale in
any market or that they will reach any particular level of sales.
In particular, management's expectations regarding
the approval and commercialization of the product candidates could
be affected by, among other things, unexpected clinical trial
results, including additional analysis of existing clinical data,
and new clinical data; unexpected regulatory actions or delays, or
government regulation generally; our ability to obtain or maintain
patent or other proprietary intellectual property protection;
competition in general; government, industry, and general public
pricing pressures; and additional factors that involve significant
risks and uncertainties about our products, product candidates,
financial results and business prospects. Should one or more of
these risks or uncertainties materialize, or should underlying
assumptions prove incorrect, actual results may vary materially
from those described herein as anticipated, believed, estimated or
expected. Starpharma is providing this information as of the date
of this document and does not assume any obligation to update any
forward-looking statements contained in this document as a result
of new information, future events or developments or
otherwise.
APPENDIX A – CLINICAL TRIAL SUMMARY
Official
Title:
|
A double-blind, multicenter,
randomized, placebo-controlled, dose-ranging study to determine the
efficacy and safety of SPL7013 Gel (VivaGel®)
administered vaginally to prevent the recurrence of bacterial
vaginosis
|
|
Identifying
Codes:
|
Starpharma Protocol Number:
SPL7013-014
|
|
Primary
Objective:
|
- To assess the efficacy of 1% and
3% SPL7013 Gel, used every second day for 16 weeks, in reducing the
rate of recurrence of bacterial vaginosis (BV) in subjects with a
history of recurrent BV
|
|
Primary
Endpoint:
|
The recurrence of BV by or at
the End of Treatment visit (Week 16)
|
|
Secondary
Objectives:
|
- To determine the safety and
tolerability of 1% and 3% SPL7013 Gel used every second day for 16
weeks
- To assess the acceptability of
treatment with 1% and 3% SPL7013 Gel
- To characterize the distribution
of times to recurrence of BV in subjects with a history of
recurrent BV when treated with SPL7013 Gel every second day for 16
weeks (vs. placebo)
|
|
Study
Design:
|
Randomized, double-blind,
multicenter, placebo-controlled, dose-ranging study of women with
active BV and a history of recurrent BV. Recurrent BV is
defined as a history of at least 3 episodes of BV in the past 12
months, including the current episode. The current diagnosis
of BV is defined by the presence of at least 3 of the 4 Amsel
criteria and subject-reported symptoms consistent with
BV.
After receiving metronidazole
for 7 days, eligible subjects will be randomized to receive 1%
SPL7013 Gel, 3% SPL7013 Gel, or placebo gel every second day for 16
weeks followed by an 8-week follow-up period.
|
|
Sites:
|
The study will be conducted at
sites in the US
|
|
Key Inclusion
Criteria:
|
- female, aged 18–45
years
- history of recurrent BV, defined
as at least 3 documented episodes in the previous 12 months
(including the current episode) as indicated by
subject's medical
history and/or record of a prescription of medication to treat an
episode of BV
- current diagnosis of BV (ie,
subject-reported symptoms consistent with BV (any vaginal discharge
considered by the subject to be abnormal, and/or unpleasant vaginal
odor) and at least 3 of 4 Amsel criteria)
- non-pregnant
- otherwise healthy, as determined
by medical history
- normal Pap smear at or
documented within 24 months of screening
|
|
|
|
FOR FURTHER INFORMATION
Media:
Buchan Consulting
Rebecca Wilson
Mob: +61-417-382-391
rwilson@bcg.com.au
Starpharma:
Dr Jackie Fairley
Chief Executive Officer
+61-3-8532-2704
Ben Rogers
Company Secretary
+61-3-8532-2702
Ben.rogers@starpharma.com
SOURCE Starpharma Holdings Limited