Nanotechnology Now





Heifer International

Wikipedia Affiliate Button


DHgate

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

SouthWest NanoTechnologies Introduces AgeNT™ Transparent Conductor System at SID Display Week, Booth #543 May 28th, 2015

New technique speeds nanoMRI imaging: Multiplexing technique for nanoscale magnetic resonance imaging developed by researchers in Switzerland cuts normal scan time from two weeks to two days May 28th, 2015

Squeezed quantum cats May 28th, 2015

New chip makes testing for antibiotic-resistant bacteria faster, easier: Researchers at the University of Toronto design diagnostic chip to reduce testing time from days to one hour, allowing doctors to pick the right antibiotic the first time May 28th, 2015

Govt.-Legislation/Regulation/Funding/Policy

Physicists precisely measure interaction between atoms and carbon surfaces May 28th, 2015

Linking superconductivity and structure May 28th, 2015

Chemists discover key reaction mechanism behind the highly touted sodium-oxygen battery May 28th, 2015

Collaboration could lead to biodegradable computer chips May 28th, 2015

Nanomedicine

New chip makes testing for antibiotic-resistant bacteria faster, easier: Researchers at the University of Toronto design diagnostic chip to reduce testing time from days to one hour, allowing doctors to pick the right antibiotic the first time May 28th, 2015

New electronic stent could provide feedback and therapy — then dissolve May 27th, 2015

Seeing the action: UCSB researchers develop a novel device to image the minute forces and actions involved in cell membrane hemifusion May 27th, 2015

Nanotechnology identifies brain tumor types through MRI 'virtual biopsy' in animal studies: If results are confirmed in humans, tumor cells could someday be diagnosed by MRI imaging and treated with tumor-specific IV injections; new NIH grant will fund future study May 27th, 2015

Announcements

Chemists discover key reaction mechanism behind the highly touted sodium-oxygen battery May 28th, 2015

New technique speeds nanoMRI imaging: Multiplexing technique for nanoscale magnetic resonance imaging developed by researchers in Switzerland cuts normal scan time from two weeks to two days May 28th, 2015

Squeezed quantum cats May 28th, 2015

New chip makes testing for antibiotic-resistant bacteria faster, easier: Researchers at the University of Toronto design diagnostic chip to reduce testing time from days to one hour, allowing doctors to pick the right antibiotic the first time May 28th, 2015

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