Navigation Links
FDA Warning for N-9 - an Opportunity for VivaGel(R)
Date:12/21/2007

MELBOURNE, Australia, Dec. 21 /PRNewswire-FirstCall/ -- Starpharma Holdings Limited (ASX:SPL, OTC: SPHRY), developer of VivaGel(R) vaginal microbicide today welcomed a decision by the US FDA this week requiring makers of products containing nonoxynol 9 (N9) to carry a warning that the products do not protect against sexually transmitted diseases, including HIV/AIDS and that the use of N-9 products is associated with an increased risk of HIV.

Starpharma's VivaGel(R) is a vaginal gel, being developed to protect women from HIV and HSV-2 (genital herpes) during sex. VivaGel(R) does not use N9. VivaGel(R) is currently in mid-stage clinical trials in the US and Kenya to add to its portfolio of safety data before embarking on population-based efficacy testing.

In the December 18 FDA release they noted:

"FDA is issuing this final rule to correct misconceptions that the chemical N9 in these widely available stand-alone contraceptive products protects against sexually transmitted diseases, including HIV infection," said Janet Woodcock, M.D., FDA's deputy commissioner for scientific and medical programs, chief medical officer, and acting director of the Center for Drug Evaluation and Research (CDER).

"Clinical research has shown that N9 provides no protection against sexually transmitted diseases to the woman if her sexual partner is infected with an STD pathogen or HIV."

In addition, FDA is requiring that the labels warn consumers that the chemical N9 in stand-alone vaginal contraceptives and spermicides can irritate the vagina and rectum, which may increase the risk of contracting HIV/AIDS from an infected partner.

"Starpharma welcomes this clear statement from the FDA," commented Jackie Fairley, Starpharma's CEO. "We feel that this emphasizes the urgent need for products such as VivaGel(R) to assist individuals protect themselves from infection with these serious diseases. Starpharma is intent on developing VivaGel(R), both as a stand-alone gel and, through our co-development agreement with SSL International plc, as a condom coating ("Starpharma and Durex sign co-development agreement for VivaGel(R)-coated condoms" Starpharma, 16 October 2007)" (see: http://www.starpharma.com/news-room.asp).

VivaGel(R) has fast track status for development for HIV from the FDA, and has received in excess of $26m funding support from the US National Institutes of Health (NIH) for its development for both HIV and HSV-2. VivaGel(R) is being developed as a potential coating on condoms and as a stand alone product to protect against the contraction of sexually transmitted infections. It has also been shown to have a contraceptive affect in animal trials.

The FDA's summary article can be found here:

http://www.fda.gov/bbs/topics/NEWS/2007/NEW01758.html

The full report by the FDA can be found here:

http://www.fda.gov/OHRMS/DOCKETS/98fr/07-6111.htm

About Starpharma

Starpharma Holdings Limited (ASX:SPL, OTCQX:SPHRY) is a world leader in the development of dendrimer nanotechnology for pharmaceutical, life-science and other applications. SPL is principally composed of two operating companies, Starpharma Pty Ltd in Melbourne, Australia and Dendritic Nanotechnologies, Inc in Michigan, USA. Products based on SPL's dendrimer technology are already on the market in the form of diagnostic elements and laboratory reagents.

The Company's lead pharmaceutical development product is VivaGel(R) (SPL7013 Gel), a vaginal microbicide designed to prevent the transmission of STIs, including HIV and genital herpes.

For further information:

Media

Rebecca Wilson

Buchan Consulting

Tel: +61 2 9237 2800

Mob: +61 417 382 391

rwilson@bcg.com.au

Ellie Papathanasiou

Buchan Consulting

Tel: +61 2 9237 2800

epapathanasiou@bcg.com.au

Starpharma

http://www.starpharma.com

Dr Jackie Fairley

Chief Executive Officer

+61 3 8532 2704

Ben Rogers

Company Secretary

+61 3 8532 2702

ben.rogers@starpharma.com


'/>"/>
SOURCE Starpharma
Copyright©2007 PR Newswire.
All rights reserved

Related medicine news :

1. Campaign for Americas Future Memorandum: Katrina Storm Warning
2. Jump in Youth Suicide Prompts National Childrens Charity KidsPeace to Issue Tips on Prevention, Warning Signs
3. Mayo Clinic study finds FDA warning against antinausea drug droperidol unnecessary
4. Common Early-Warning Symptoms of Ovarian Cancer Identified in CDC/Thomson Healthcare Study
5. Defib Wire Warning Shouldnt Worry Most Users: Experts
6. India, UK Join Growing List of Countries to Require Pictorial Tobacco Warnings
7. Thoratecs ITC Division Receives FDA Warning Letter
8. FDA Issues New Warnings for Anemia Drugs
9. Warning for women who binge drink
10. Avandia Label to Get Heart-Attack Warning
11. FDA Mulls Tougher Warning Label on Kids Flu Drugs
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:10/13/2017)... ... October 13, 2017 , ... ... communities in the greater Dallas, Miami, and Raleigh regions, is organizing an extended ... overcome a rare and deadly chromosome abnormality. , After struggling since birth with ...
(Date:10/13/2017)... ... 13, 2017 , ... The International Association of Eating Disorders ... for the field of eating disorders, announces the opening of early registration for ... Florida at the Omni Resort at ChampionsGate. , The annual iaedp™ ...
(Date:10/13/2017)... (PRWEB) , ... October 13, 2017 , ... Many families ... However, many long-term care insurance companies have a waiver for care if the client ... elimination period, when the family pays for care, is often waived, so the benefits ...
(Date:10/13/2017)... ... October 13, 2017 , ... Talented host, actor ... on sciatica in a new episode of "Success Files," which is an award-winning ... innovation and investigates each subject in-depth with passion and integrity. , Sciatica occurs ...
(Date:10/12/2017)... ... October 12, 2017 , ... CitiDent and ... apnea using cutting-edge Oventus O2Vent technology. As many as 18 million Americans ... frequent cessation in breathing. Oral appliances can offer significant relief to about 75 ...
Breaking Medicine News(10 mins):
(Date:9/27/2017)... 27, 2017  Commended for their devotion to personalized service, ... as number one in the South Florida Business Journal,s 50 ... 5000 yearly list, the national specialty pharmacy has found its ... will soon be honored by SFBJ as the 2017 ... Set to receive his award in October, Bardisa said ...
(Date:9/25/2017)... 2017  EpiVax, Inc., a leader in the ... today announced the launch of EpiVax Oncology Inc., ... therapeutic cancer vaccines. EpiVax has provided $500,000 in ... enabling technologies to the new precision immunotherapy venture. ... Oncology as Chief Executive Officer. Gad brings over ...
(Date:9/22/2017)... , Sept. 22, 2017 AVACEN Medical (AVACEN) ... is now successfully helping those with the widespread pain ... Fibromyalgia diagnosed Amanda in Essex, England ... washing my hair, experiencing no sleep at all, tremendous ... spasm… I cannot recommend [the AVACEN 100] enough, how ...
Breaking Medicine Technology: