Nanotechnology Now

Our NanoNews Digest Sponsors



Heifer International

Wikipedia Affiliate Button


android tablet pc

Home > Press > Starpharma’s VivaGel® Phase 3 trials 60% enrolled

Abstract:
Key points

· Enrolment passes 60% for VivaGel® Phase 3 BV treatment trials

· Trials well on track for completion in 2012

· One of the trials has already enrolled more than 80% of subjects

Starpharma’s VivaGel® Phase 3 trials 60% enrolled

Melbourne, Australia | Posted on June 3rd, 2012

Starpharma Holdings Ltd (ASX:SPL, OTCQX: SPHRY) is pleased to report excellent progress in the recruitment for its pivotal Phase 3 trials for VivaGel® as a treatment for bacterial vaginosis (BV).

Two concurrent Phase 3 trials are underway and recruitment for these trials, which commenced in late March 2012, has recently passed the halfway mark with 60% of patients already enrolled. One of the trials has already exceeded 80% enrolment.

The Phase 3 treatment trials are taking place across more than 30 international sites, primarily in the United States. Following the completion of the Phase 3 trials Starpharma expects to prepare and submit a New Drug Application (NDA) to the US Food and Drug Administration (FDA) in parallel with engaging in licensing negotiations. The FDA has already provided formal agreement as part of a Special Protocol Assessment (SPA) declaring that the phase 3 trials' design, clinical endpoints and statistical analyses are acceptable for FDA approval once completed.

"We are extremely pleased with the rate of enrolment for the pivotal Phase 3 trials underway. We are already approaching two thirds enrolment in less than three months, which means we are well on track to complete and report the trials in 2012 as indicated," said Dr Jackie Fairley, Chief Executive Officer of Starpharma.

BV is the most common vaginal infection worldwide, and the most common cause of vaginal irritation, discharge and malodour. It is particularly prevalent in the US, where it affects an estimated one-third of the adult female population. BV is often implicated in pelvic inflammatory disease and may also be associated with pre-term birth and an increased risk of sexually transmitted infections, including HIV.

"Completion of these Phase 3 trials is a very important milestone for Starpharma as it is the precursor to seeking regulatory approval for VivaGel® as a treatment for BV," Dr Fairley said.

The market for topical treatments of BV is estimated at US$300-$350 million. However, existing conventional antibiotic treatments are considered suboptimal with relatively low cure rates and high rates of recurrence, unpleasant side-effects, and high levels of bacterial resistance. VivaGel® is a non-antibiotic gel that is applied to the vagina with an applicator. VivaGel® is not absorbed into the bloodstream (as antibiotics are), and as such it is not associated with the side effects of antibiotics. Clinical trials of VivaGel® have shown a high level of patient acceptability.

Details of the Phase 3 trial design are contained in the announcement of the trial commencement made on 22 March 2012 available at www.starpharma.com/asx_announcements

####

For more information, please click here

Contacts:
Haley Price
Account Manager
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

Oregon researchers glimpse pathway of sunlight to electricity: Collaboration with Lund University uses modified UO spectroscopy equipment to study 'maze' of connections in photoactive quantum dots December 19th, 2014

Instant-start computers possible with new breakthrough December 19th, 2014

Aculon Hires New Business Development Director December 19th, 2014

Iranian Scientists Use Nanotechnology to Increase Power, Energy of Supercapacitors December 18th, 2014

Govt.-Legislation/Regulation/Funding/Policy

Oregon researchers glimpse pathway of sunlight to electricity: Collaboration with Lund University uses modified UO spectroscopy equipment to study 'maze' of connections in photoactive quantum dots December 19th, 2014

Zenosense, Inc. - Hospital Collaboration - 400 Person Lung Cancer Detection Trial December 17th, 2014

SUNY Poly NanoCollege Faculty Member Selected as American Physical Society Fellow: SUNY Poly Associate Professor of Nanoscience Dr. Vincent LaBella Recognized for Significant Technological Innovations that Enable Interactive Learning December 17th, 2014

Switching to spintronics: Berkeley Lab reports on electric field switching of ferromagnetism at room temp December 17th, 2014

Nanomedicine

Creation of 'Rocker' protein opens way for new smart molecules in medicine, other fields December 18th, 2014

Iranian Researchers Produce Electrical Pieces Usable in Human Body December 18th, 2014

Zenosense, Inc. - Hospital Collaboration - 400 Person Lung Cancer Detection Trial December 17th, 2014

Unraveling the light of fireflies December 17th, 2014

Announcements

Oregon researchers glimpse pathway of sunlight to electricity: Collaboration with Lund University uses modified UO spectroscopy equipment to study 'maze' of connections in photoactive quantum dots December 19th, 2014

Instant-start computers possible with new breakthrough December 19th, 2014

Aculon Hires New Business Development Director December 19th, 2014

Iranian Scientists Use Nanotechnology to Increase Power, Energy of Supercapacitors December 18th, 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