Important note: Information in this article was accurate in 2007. The state of the art may have changed since the publication date.
PRNewswire - December 21, 2007
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 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.
Source: Starpharma
CONTACT: Rebecca Wilson, Tel: +61 2 9237 2800, Mobile: +61 417 382 391, rwilson@bcg.com.au, Ellie Papathanasiou, +61 2 9237 2800, epapathanasiou@bcg.com.au, both of Buchan Consulting; Dr Jackie Fairley, Chief Executive Officer, +61 3 8532 2704, Ben Rogers, Company Secretary, +61 3 8532 2702, ben.rogers@starpharma.com, both of Starpharma
Web site: http://www.starpharma.com/
071221
PR071241
Copyright © 2007 - PRNewswire. All rights reserved. Reproduced with permission. Reproduction of this article (other than one copy for personal reference) must be cleared through PRNewswire, Permissions, 810 Seventh Ave., 32nd Floor, New York, NY 10019 http://www.prnewswire.com.
AEGiS is a 501(c)3, not-for-profit, tax-exempt, educational corporation. AEGiS is made possible through unrestricted funding from Broadway Cares/Equity Fights AIDS, Elton John AIDS Foundation, the National Library of Medicine, Pacific Life Foundation and donations from users like you.
Always watch for outdated information. This article first appeared in 2007. This material is designed to support, not replace, the relationship that exists between you and your doctor.
AEGiS presents published material, reprinted with permission and neither endorses nor opposes any material. All information contained on this website, including information relating to health conditions, products, and treatments, is for informational purposes only. It is often presented in summary or aggregate form. It is not meant to be a substitute for the advice provided by your own physician or other medical professionals. Always discuss treatment options with a doctor who specializes in treating HIV.
Copyright ©1980, 2007. AEGiS. All materials appearing on AEGiS are protected by copyright as a collective work or compilation under U.S. copyright and other laws and are the property of AEGiS, or the party credited as the provider of the content. .