Melbourne, Australia; 21 November, 2011: Starpharma (ASX: SPL; OCTQX: SPHRY) today announced that the Phase 3 clinical trial program for VivaGel® bacterial vaginosis (BV) treatment has now also been agreed with the European Medicines Agency (EMA).
This European scientific advice is in addition to the agreement recently reached with the US Food and Drug Administration (FDA) announced by the Company on 10 October, 2011.
Starpharma recently presented to the EMA the proposed design of Phase 3 studies and associated aspects of the development program to support a (European) Marketing Authorisation Application (MAA) for VivaGel® for the treatment of BV. Following these discussions, Starpharma now has reached agreement on Phase 3 clinical trial design with the regulatory authorities for both the US and Europe.
The significance of the EMA feedback is that Starpharma has now confirmed for both major global markets – Europe and the US – that its Phase 3 program is acceptable, and positive results (as recently achieved for the Phase 2) would support approval of the product.
As previously announced, the company plans to commence its Phase 3 BV Treatment program early in 2012 with completion expected before year end. Following the completion of Phase 3 trials the company plans to partner the product.
These two Phase 3 studies will be conducted in parallel and the design – now agreed with both the FDA and EMA – is very similar to Starpharma’s successful Phase 2 trial of VivaGel® for the treatment of BV. As for Starpharma’s recently completed Phase 2 study, the primary endpoint in the Phase 3 trials will be Clinical Cure, as assessed by resolution of symptoms and other standard clinical criteria, and the comparator will be placebo gel.
“We are pleased that both the FDA and now the EMA have agreed with our proposed clinical program for BV treatment for Phase 3. We look forward to commencing the program early in the New Year and, following our recent financing, we plan to add some additional trial sites to further expedite its completion.” said Starpharma Chief Executive Officer, Dr Jackie Fairley.
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 Ansell Limited 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.
A dendrimer is a type of precisely-defined, branched nanoparticle. the medical, electronics, chemicals and materials industries.
Dendrimers have applications in 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.
Media: Buchan Consulting
Mob: +61 417 382 391
Mob: +61 423 139 163
Dr Jackie Fairley, Chief Executive Officer
+61 3 8532 2704
Ben Rogers, Company Secretary
+61 3 8532 2702
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