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

'Stealth' nanoparticles could improve cancer vaccines October 1st, 2014

Stressed Out: Research Sheds New Light on Why Rechargeable Batteries Fail October 1st, 2014

New Absorber Will Lead to Better Biosensor: Biosensors are more sensitive and able to detect smaller changes in the environment October 1st, 2014

Graphene chips are close to significant commercialization October 1st, 2014

Govt.-Legislation/Regulation/Funding/Policy

Platinum meets its match in quantum dots from coal: Rice University's cheap hybrid outperforms rare metal as fuel-cell catalyst October 1st, 2014

$18-million NSF investment aims to take flat materials to new heights: 2-D alternatives to graphene may enable exciting advances in electronics, photonics, sensors and other applications October 1st, 2014

Novel approach to magnetic measurements atom-by-atom October 1st, 2014

'Stealth' nanoparticles could improve cancer vaccines October 1st, 2014

Nanomedicine

Arrowhead Expands Management Team with Appointment of Susan Boynton as Vice President Global Regulatory Affairs October 1st, 2014

Nanobotmodels present metastasis and angiogenesis medical animation October 1st, 2014

'Stealth' nanoparticles could improve cancer vaccines October 1st, 2014

New Absorber Will Lead to Better Biosensor: Biosensors are more sensitive and able to detect smaller changes in the environment October 1st, 2014

Announcements

'Stealth' nanoparticles could improve cancer vaccines October 1st, 2014

Stressed Out: Research Sheds New Light on Why Rechargeable Batteries Fail October 1st, 2014

New Absorber Will Lead to Better Biosensor: Biosensors are more sensitive and able to detect smaller changes in the environment October 1st, 2014

Graphene chips are close to significant commercialization October 1st, 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