FDA Warning for N-9 - an Opportunity for VivaGel(R)
Starpharma's VivaGel(R) is a vaginal gel, being developed to protect womenfrom 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 toadd to its portfolio of safety data before embarking on population-basedefficacy testing.
In the December 18 FDA release they noted:
"FDA is issuing this final rule to correct misconceptions that thechemical N9 in these widely available stand-alone contraceptive productsprotects against sexually transmitted diseases, including HIV infection," saidJanet Woodcock, M.D., FDA's deputy commissioner for scientific and medicalprograms, chief medical officer, and acting director of the Center for DrugEvaluation and Research (CDER).
"Clinical research has shown that N9 provides no protection againstsexually transmitted diseases to the woman if her sexual partner is infectedwith an STD pathogen or HIV."
In addition, FDA is requiring that the labels warn consumers that thechemical N9 in stand-alone vaginal contraceptives and spermicides can irritatethe vagina and rectum, which may increase the risk of contracting HIV/AIDSfrom an infected partner.
"Starpharma welcomes this clear statement from the FDA," commented JackieFairley, Starpharma's CEO. "We feel that this emphasizes the urgent need forproducts such as VivaGel(R) to assist individuals protect themselves frominfection with these serious diseases. Starpharma is intent on developingVivaGel(R), both as a stand-alone gel and, through our co-developmentagreement with SSL International plc, as a condom coating ("Starpharma andDurex 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, andhas received in excess of $26m funding support from the US National Institutesof Health (NIH) for its development for both HIV and HSV-2. VivaGel(R) isbeing developed as a potential coating on condoms and as a stand alone productto protect against the contraction of sexually transmitted infections. It hasalso been shown to have a contraceptive affect in animal trials.
Starpharma Holdings Limited (ASX:SPL, OTCQX:SPHRY) is a world leader inthe development of dendrimer nanotechnology for pharmaceutical, life-scienceand other applications. SPL is principally composed of two operatingcompanies, Starpharma Pty Ltd in Melbourne, Australia and DendriticNanotechnologies, Inc in Michigan, USA. Products based on SPL's dendrimertechnology are already on the market in the form of diagnostic elements andlaboratory reagents.
The Company's lead pharmaceutical development product is VivaGel(R)(SPL7013 Gel), a vaginal microbicide designed to prevent the transmission ofSTIs, including HIV and genital herpes.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
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