Nanotechnology Now

Our NanoNews Digest Sponsors





Heifer International

Wikipedia Affiliate Button


android tablet pc

Home > Press > SPL receives FDA Special Protocol Assessment for BV Phase 3

Abstract:
Starpharma (ASX: SPL; OCTQX: SPHRY) today announced that it has received final written agreement from the FDA on the design of its Phase 3 clinical studies of VivaGel® for the treatment of bacterial vaginosis (BV) under the FDA's Special Protocol Assessment (SPA) scheme.

SPL receives FDA Special Protocol Assessment for BV Phase 3

Melbourne, Australia | Posted on January 11th, 2012

The SPA is a binding declaration from the FDA that the Phase 3 clinical study design, endpoints, statistical analyses, and other aspects of the planned studies are acceptable to support regulatory approval of the product.

"Receiving this SPA agreement gives Starpharma great confidence in our Phase 3 program, and allows us to proceed through this final development stage with a high level of clarity about the approval pathway for VivaGel® for treatment of BV," said Dr Jackie Fairley, Chief Executive Officer of Starpharma.

"It was pleasing to have received binding agreement so rapidly and without the need for further discussion with the Agency," she said.

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.

"Following our recent financing, we are also implementing various initiatives in collaboration with our CRO to expedite the trial timelines as much as possible," added Dr Fairley.

These two Phase 3 studies will be conducted in parallel and the design - now agreed with both the FDA and EMA - is extremely similar to Starpharma's successful Phase 2 trial of VivaGel® for the treatment of BV.

####

For more information, please click here

Contacts:
BUCHAN CONSULTING
LEVEL 13 499 ST KILDA ROAD
MELBOURNE AUSTRALIA 3004
TEL +61 3 8866 1210
MOB +61 (0) 423 139 163
www.buchanwe.com.au

Copyright © Starpharma Holdings Limited

If you have a comment, please Contact us.

Issuers of news releases, not 7th Wave, Inc. or Nanotechnology Now, are solely responsible for the accuracy of the content.

Bookmark:
Delicious Digg Newsvine Google Yahoo Reddit Magnoliacom Furl Facebook

Related News Press

News and information

East China University of Science and Technology Purchases Nanonex Advanced Nanoimprint Tool NX-B200 July 30th, 2014

Watching Schrödinger's cat die (or come to life): Steering quantum evolution & using probes to conduct continuous error correction in quantum computers July 30th, 2014

From Narrow to Broad July 30th, 2014

FLAG-ERA and TNT2014 join efforts: Graphene Networking at its higher level in Barcelona: Encourage the participation in a joint transnational call July 30th, 2014

Govt.-Legislation/Regulation/Funding/Policy

New imaging agent provides better picture of the gut July 30th, 2014

Watching Schrödinger's cat die (or come to life): Steering quantum evolution & using probes to conduct continuous error correction in quantum computers July 30th, 2014

Nature inspires a greener way to make colorful plastics July 30th, 2014

Tough foam from tiny sheets: Rice University lab uses atom-thick materials to make ultralight foam July 29th, 2014

Nanomedicine

New imaging agent provides better picture of the gut July 30th, 2014

Zenosense, Inc. July 29th, 2014

Optimum inertial design for self-propulsion: A new study investigates the effects of small but finite inertia on the propulsion of micro and nano-scale swimming machines July 29th, 2014

FEI adds Phase Plate Technology and Titan Halo TEM to its Structural Biology Product Portfolio: New solutions provide the high-quality imaging and contrast necessary to analyze the 3D structure of molecules and molecular complexes July 28th, 2014

Announcements

University of Manchester selects Anasys AFM-IR for coatings and corrosion research July 30th, 2014

Nature inspires a greener way to make colorful plastics July 30th, 2014

Analytical solutions from Malvern Instruments support University of Wisconsin-Milwaukee researchers in understanding environmental effects of nanomaterials July 30th, 2014

FEI Unveils New Solutions for Faster Time-to-Analysis in Metals Research July 30th, 2014

NanoNews-Digest
The latest news from around the world, FREE



  Premium Products
NanoNews-Custom
Only the news you want to read!
 Learn More
NanoTech-Transfer
University Technology Transfer & Patents
 Learn More
NanoStrategies
Full-service, expert consulting
 Learn More














ASP
Nanotechnology Now Featured Books




NNN

The Hunger Project







© Copyright 1999-2014 7th Wave, Inc. All Rights Reserved PRIVACY POLICY :: CONTACT US :: STATS :: SITE MAP :: ADVERTISE