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:12/9/2016)... ... December 09, 2016 , ... The ... Hotel in New York, NY, on December 3rd, to benefit Holy Name Medical ... the annual event, which raised over $1 million - the largest event in ...
(Date:12/8/2016)... ... December 08, 2016 , ... The ... beginning January 1, 2017. The name change aligns the entire company with ... improving health care quality. , “We are very proud of the achievements associated ...
(Date:12/8/2016)... ... December 08, 2016 , ... ZyDoc , ... Processing–Enabled and Conventional Data Capture Methods for Input to Electronic Health Records: A ... Results of the comparative usability study demonstrate that a dictation-based method (“NLP Entry”) ...
(Date:12/8/2016)... ... ... the increasing demand for dental implants, the National Association of Dental Laboratories ( NADL ... about the safety issues related to dental restorations. According to the American Academy of ... reach $6.4 billion in 2018 with more than 30 million Americans missing all their ...
(Date:12/8/2016)... ... December 08, 2016 , ... Launching of ... Unified Instance Manager architecture, meeting the needs of multichannel growth and doubling ... unattended auto-dialing system without agents, Presence Robodialer, provides greater operational capacity, administrative ...
Breaking Medicine News(10 mins):
(Date:12/8/2016)... VIEW, Calif. , Dec. 8, 2016 IRIDEX ... intends to offer newly issued shares of common stock, $0.01 ... pursuant to an underwritten public offering.  The final terms of ... the time of pricing, and there can be no assurance ... IRIDEX expects to use the net proceeds it ...
(Date:12/8/2016)... global biosurgery market is expected to grow at a ... to 2021. The market is poised to reach USD ... 2016. The market is primarily driven by rising number ... spinal problems, increasing clearance of biosurgery products by regulatory ... In this report, the biosurgery market is ...
(Date:12/8/2016)... Pharmacy, Inc. (NYSE: DPLO) has been recognized by the Detroit ... Standard. To learn more about Diplomat,s career opportunities, visit ... ... ... LLC, a research firm specializing in organizational health and workplace improvement. ...
Breaking Medicine Technology: