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 VivaGelŪ 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 VivaGelŪ 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 VivaGelŪ 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

The International Space Elevator Consortium (ISEC) is proud to announce the 2014 Space Elevator Conference! This annual event will be held at the Museum of Flight in Seattle, Washington from Friday, August 22nd through Sunday, August 24th August 19th, 2014

KaSAM-2014 International Conference (September 7-10, 2014, Kathmandu, Nepal) August 19th, 2014

Success in Intracellular Imaging of Cesium Distribution in Plants Used for Cesium Absorption August 19th, 2014

Electrical engineers take major step toward photonic circuits: Team invents non-metallic metamaterial that enables them to 'compress' and contain light August 19th, 2014

Govt.-Legislation/Regulation/Funding/Policy

Success in Intracellular Imaging of Cesium Distribution in Plants Used for Cesium Absorption August 19th, 2014

Electrical engineers take major step toward photonic circuits: Team invents non-metallic metamaterial that enables them to 'compress' and contain light August 19th, 2014

Promising Ferroelectric Materials Suffer From Unexpected Electric Polarizations: Brookhaven Lab scientists find surprising locked charge polarizations that impede performance in next-gen materials that could otherwise revolutionize data-driven devices August 18th, 2014

Novel chip-based platform could simplify measurements of single molecules: A nanopore-gated optofluidic chip combines electrical and optical measurements of single molecules onto a single platform August 14th, 2014

Nanomedicine

Graphene rubber bands could stretch limits of current healthcare, new research finds August 19th, 2014

Interaction between Drug, DNA for Designing Anticancer Drugs Studied in Iran August 17th, 2014

Scientists fold RNA origami from a single strand: RNA origami is a new method for organizing molecules on the nanoscale. Using just a single strand of RNA, this technique can produce many complicated shapes. August 14th, 2014

Iranian Scientists Stabilize Protein on Highly Stable Electrode Surface August 14th, 2014

Announcements

Сalculations with Nanoscale Smart Particles August 19th, 2014

Life on Mars? Implications of a newly discovered mineral-rich structure August 19th, 2014

Harris & Harris Group Letter to Shareholders on Website August 19th, 2014

Electrical engineers take major step toward photonic circuits: Team invents non-metallic metamaterial that enables them to 'compress' and contain light August 19th, 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