![[personal profile]](https://www.dreamwidth.org/img/silk/identity/user.png){kind=small}
I've written about VivaGel before and I'm very excited about it.
Basically, it's a gel whose active ingredient prevents the transmission of all 4 strains of high-risk HPV that Gardasil & Cervarix do, plus another 2 strains not covered by the vaccines AND it seems to protect against HIV and Herpes! In clinical studies, human vaginal cells were treated with the active ingredient, then introduced to HSV and HIV 1, 3, 12, and 24 hours after being treated. It showed 100% antiviral activity up to 12 hours, and for 12 and 24 hours it showed 90% antiviral activity in more than half the women tested. It ALSO shows contraceptive properties in animals.
Well, VivaGel has now concluded its initial human testing studies and has been found to be safe for human use. http://www.starpharma.com/vivagel.asp. VivaGel has been awarded US$20.3 million from the US-based National Institutes of Health to develop its HIV indication. The NIH also made an additional award to develop its HSV-2 (genital herpes) indication.
VivaGel was granted Fast Track status by the US FDA in 2006 as a product for prevention of HIV infection. This designation will accelerate the clinical and regulatory development path. Their microbicide program has received further support in other areas including a US$5.4 million grant from the NIH to develop combination microbicides in collaboration with ReProtect Inc.
The human papillomavirus (HPV) will become the third disease area under investigation for VivaGel® following encouraging pre-clinical data.
Oh, and they are looking at marketing it both as a topical microbe (i.e. a lubricant and/or vaginal insert) AND as a condom coating to replace Nonoxynol 9 (N-9), which has spermicidal properties. Because of its detergent nature, N-9 has been shown to increase the risk of infection with HIV and other viruses such as HSV-2, which is why I won't use it. The company researching and manufacturing VivaGel has signed agreements with two leading condom companies to develop VivaGel as a condom coating. For regulatory reasons, the approval process for VivaGel® in this application may offer a faster route to market than the stand-alone gel.
So be on the lookout in a couple of years for products with VivaGel!
Basically, it's a gel whose active ingredient prevents the transmission of all 4 strains of high-risk HPV that Gardasil & Cervarix do, plus another 2 strains not covered by the vaccines AND it seems to protect against HIV and Herpes! In clinical studies, human vaginal cells were treated with the active ingredient, then introduced to HSV and HIV 1, 3, 12, and 24 hours after being treated. It showed 100% antiviral activity up to 12 hours, and for 12 and 24 hours it showed 90% antiviral activity in more than half the women tested. It ALSO shows contraceptive properties in animals.
Well, VivaGel has now concluded its initial human testing studies and has been found to be safe for human use. http://www.starpharma.com/vivagel.asp. VivaGel has been awarded US$20.3 million from the US-based National Institutes of Health to develop its HIV indication. The NIH also made an additional award to develop its HSV-2 (genital herpes) indication.
VivaGel was granted Fast Track status by the US FDA in 2006 as a product for prevention of HIV infection. This designation will accelerate the clinical and regulatory development path. Their microbicide program has received further support in other areas including a US$5.4 million grant from the NIH to develop combination microbicides in collaboration with ReProtect Inc.
The human papillomavirus (HPV) will become the third disease area under investigation for VivaGel® following encouraging pre-clinical data.
Oh, and they are looking at marketing it both as a topical microbe (i.e. a lubricant and/or vaginal insert) AND as a condom coating to replace Nonoxynol 9 (N-9), which has spermicidal properties. Because of its detergent nature, N-9 has been shown to increase the risk of infection with HIV and other viruses such as HSV-2, which is why I won't use it. The company researching and manufacturing VivaGel has signed agreements with two leading condom companies to develop VivaGel as a condom coating. For regulatory reasons, the approval process for VivaGel® in this application may offer a faster route to market than the stand-alone gel.
So be on the lookout in a couple of years for products with VivaGel!
