FDA Warning for Starpharma Holdings Ltd's N-9 - an Opportunity for VivaGel(R)
Published: Dec 21, 2007
MELBOURNE, Australia, Dec. 21 /PRNewswire-FirstCall/ -- Starpharma Holdings Limited , 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.
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.
CONTACT: Rebecca Wilson, Tel: +61 2 9237 2800, Mobile: +61 417 382 391,
firstname.lastname@example.org, Ellie Papathanasiou, +61 2 9237 2800,
email@example.com, both of Buchan Consulting; Dr Jackie Fairley,
Chief Executive Officer, +61 3 8532 2704, Ben Rogers, Company Secretary,
+61 3 8532 2702, firstname.lastname@example.org, both of Starpharma
Web site: http://www.starpharma.com//