Home > Press > VivaGel® BV Phase 3 trials - recruitment complete
Starpharma Holdings Ltd (ASX:SPL;OTCQX: SPHRY) today announced completion of recruitment in its two Phase 3 trials investigating VivaGel® as a treatment for bacterial vaginosis (BV).
VivaGel® BV Phase 3 trials - recruitment complete
Melbourne, Australia | Posted on October 19th, 2012
The Phase 3 treatment trials were conducted across more than 30 international sites, and recruited 250 patients per trial. The results of the trials are expected to be available by early December 2012 - following the completion of patient follow-up, data collection and the necessary statistical analyses.
These double-blind Phase 3 studies are the subject of a formal agreement with FDA under the Special Protocol Assessment (SPA) program, which confirms that the trial design, clinical endpoints and statistical analyses are acceptable for FDA approval once complete.
Recruitment is also complete for Starpharma's Phase 2 study for the prevention of BV recurrence. Completion of this trial is on track for Q4 2012 with results expected early in 2013.
In the meantime, an active dialogue continues with a number of potential licensing partners as do activities to support an NDA and other regulatory submissions. The required manufacturing validation and scale up activities are also now complete.
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. Studies indicate as many as 50-60% of those women have recurrent episodes of BV and with no treatments currently approved for the prevention of recurrence of BV, that market is estimated to be in excess of $1 billion. In addition, existing treatments for BV are considered suboptimal with relatively low cure rates and high rates of recurrence, unpleasant side-effects, and high levels of bacterial resistance.
VivaGel® is a non-antibiotic gel that is not absorbed into the bloodstream (as antibiotics are), and as such it is not associated with the problematic side effects of antibiotics. Clinical trials of VivaGel® show a high level of patient acceptability and research with clinicians and patients indicate significant unmet need in the management of this disease.
About Starpharma Holdings Limited
Starpharm Holdings Limited (ASX:SPL, OTCQX:SPHRY), located in Melbourne Australia, a world leader in the development of dendrimer products for pharmaceutical, life science and other applications. Starpharma’s underlying technology is built around dendrimers – a type of synthetic nanoscale polymer that is highly regular in size and structure and well suited to pharmaceutical uses. Starpharma has three core development programs: VivaGel® portfolio, drug delivery, and agrochemicals with the Company developing a number of products internally and others via commercial partnerships.
Starpharma’s lead product is VivaGel® (SPL7013 Gel), a gel-based formulation of a proprietary dendrimer. VivaGel® is under clinical development for the treatment and prevention of bacterial vaginosis (BV) and also as a vaginal microbicide to prevent the transmission of sexually transmitted infections including HIV and genital herpes. Starpharma has also signed separate licence agreements with Ansell Limited (ASX:ANN) and Okamoto Industries Inc (Tokyo Stock Exchange) to market a value-added, VivaGel®-coated condom. Ansell manufactures and sells leading condom brands worldwide, including Lifestyles®, ZERO® and SKYN®. Okamoto is the market leader for condoms sold in Japan, the world’s second largest condom market.
In the wider pharmaceutical and life science fields, Starpharma has both partnered and internal programs in Drug Delivery. Most recently Starpharma announced pre-clinical results in its Docetaxel (Taxotere®) program demonstrating significant improvements in that agent’s anticancer efficacy and the enhancement of solubility offering potential safety benefits as well. The company is also exploring dendrimer opportunities in agrochemicals in a series of industry partnerships with leading industry players including Nufarm (ASX:NUF) as well as with internal programs including an enhanced version of glyphosate (the active ingredient in Roundup®).
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.
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