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 a
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