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Home > Press > Full enrolment achieved for BV Phase 2 trial and first Phase 3 trial

Abstract:
Key Points:

· Recruitment 100% complete for VivaGel® Phase 2 prevention study for bacterial vaginosis (BV)

· Recruitment for two pivotal Phase 3 BV treatment studies proceeding rapidly with enrolment of the first trial now 100% complete

· Phase 3 treatment trials and the Phase 2 prevention trial all expected to complete in 2H CY2012.

· Activities to support NDA submission, including manufacturing scale up and validation, well advanced

Full enrolment achieved for BV Phase 2 trial and first Phase 3 trial

Melbourne, Australia | Posted on June 24th, 2012

Starpharma Holdings Ltd (ASX:SPL; OTCQX: SPHRY) is pleased to report that recruitment is now 100% complete for its Phase 2 clinical trial to investigate the ability of VivaGel® to prevent the recurrence of BV, and also for the first of two pivotal Phase 3 studies of VivaGel® for the treatment of BV.

The Phase 2 prevention study is being conducted under an investigational new drug application (IND) and has enrolled 205 patients with a prior history of recurrent BV. The trial is being conducted across multiple sites in the US. The primary objective of the study is to determine the efficacy of two strengths of VivaGel® (containing 1% or 3% SPL7013) compared with a placebo gel in preventing recurrence of BV. The product is used every second day over a period of 16 weeks.

"The high rates of recurrence of bacterial vaginosis reported by clinicians and their patients are driving significant demand for an effective approach to prevent the recurrence of this condition. BV has a significant impact on the quality of life of women who suffer chronic bouts, but worse, can lead to more serious reproductive and sexual health complications," said Dr Jackie Fairley, Starpharma Chief Executive Officer.

Further to the Company's announcement on 4 June 2012, which provided a progress report on recruitment, Starpharma is pleased to advise that the first of its two Phase 3 studies has also now completed recruitment with 250 patients enrolled. These Phase 3 studies of VivaGel® as a treatment for BV 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. The two Phase 3 trials and the Phase 2 trial for prevention of recurrence are all expected to complete in 2H CY2012.

Furthermore, as well as the excellent clinical trial progress, Starpharma is pleased to report that the other activities to support its proposed new drug application (NDA) submission for VivaGel® for the treatment of BV, which will follow soon after the announcement of Phase 3 trial results, are well advanced.

To support product launch and marketing volumes, Starpharma has already completed full scale up of the VivaGel® active ingredient, SPL7013, to the tens of kilograms scale under full good manufacturing practices (cGMP) at an FDA and EU-certified manufacturer that supplies marketed pharmaceutical actives globally. Scale up of the finished product to the multiple hundreds of kilograms scale has also been achieved and planning of final process validation, which will follow after submission of an NDA, is well advanced.

As previously reported, the nonclinical toxicology program for VivaGel® is already complete to support the NDA submission.

These achievements and activities are all aimed at expediting the approval and launch process.

BV is the most common vaginal infection worldwide, and the most common cause of vaginal irritation, discharge and malodour. It is particularly prevalent in the US, where it affects an estimated one-third of the adult female population and up to 50% of the female population in some regions. Studies indicate as many as 50-60% of those women have recurrent episodes of BV[i] .

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. There are no treatments currently on market for the prevention of recurrence of BV; however the market is estimated to be in excess of $1 billion.

VivaGel® is a non-antibiotic gel that is applied to the vagina with an applicator. VivaGel® is not absorbed into the bloodstream (as antibiotics are), and as such it is not associated with the side effects of antibiotics. Clinical trials of VivaGel® show a high level of patient acceptability.

1 (Marrazzo, 2011; Bradshaw et al, 2006)

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About Starpharma Holdings Limited
Starpharma Holdings Limited (ASX:SPL, OTCQX:SPHRY) is an ASX 300 company and is 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. In addition, products for diagnostics and laboratory reagents are already on market through licence arrangements with partners including Siemens Healthcare and Merck KGaA.

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 (TSE) 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 as well as with internal programs including an enhanced version of glyphosate (the active ingredient in Roundup®).

Starpharma’s headquarters and research facilities are located in Melbourne, Australia.

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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Contacts:
Media:
Buchan Consulting
Rebecca Wilson
Mob: +61 417 382 391
Haley Price
Mob: +61 423 139 163

Starpharma:
Dr Jackie Fairley
Chief Executive Officer
+61 3 8532 2704
Ben Rogers
Company Secretary