The agreement includes a program of evaluation and development and also commercial rights covering condoms with VivaGel coatings within a specified geographical region. The condom company, whose name may not be disclosed for reasons of confidentiality, holds the leading market position within that region. The market in question is in the developed world, and ranks within the top five globally, measured by GDP.
The terms of the agreement were not disclosed.
"We are pleased to be able to report this solid progress in the commercialisation of VivaGel as a condom coating," commented Starpharma CEO, Dr Jackie Fairley. "This announcement reflects some of the growing momentum that we are achieving as we work to bring VivaGel as a condom coating to market."
VivaGel is in development as a vaginal microbicide, to prevent infection with HIV or genital herpes, under two FDA INDs. It has also been shown to have a potent contraceptive effect in animals. Its development as a condom coating represents a line extension to the standalone, applicator delivered vaginal microbicide.
Meanwhile, the company has also announced the commencement in the US of a trial to assess the safety and acceptability of SPL7013 Gel (VivaGel™) in sexually active young women.
The Microbicide Trials Network (MTN) is leading the study, funded by the US National Institutes of Health (NIH), in which VivaGel™ will be tested for the first time in sexually active young women to determine its safety, acceptability and ease of
use. VivaGel™ is being developed as a vaginal microbicide for the prevention of HIV and genital herpes.
The expanded safety study is being conducted at the University of South Florida in Tampa, Florida, and the University of Puerto Rico in San Juan, Puerto Rico, through a collaboration between the MTN (an HIV/AIDS clinical trials network established by the National Institute of Allergy and Infectious Diseases, NIH), the Adolescent Medicine Trials Network for HIV/AIDS Interventions (of the National Institute of Child
Health and Human Development, NIH), and Starpharma.
Nearly 50% of people infected with HIV/AIDS today are women and most of them become infected through sexual intercourse with male partners. Women under the age of 25 are particularly at risk of infection.
"We have already conducted clinical trials on the safety of VivaGel™ in sexually inactive women and men, but this is the first time the product will be used in sexually active young women, one of our target populations. This study, in addition to the usual safety data, will collect valuable information regarding the product's use and acceptability in the consumer setting," said Dr Fairley, CEO.
"The data from this trial will provide information of value to the development of VivaGel™ for all indications, including preventing the spread of genital herpes," added Dr Fairley.
The study will enroll 40 sexually active, HIV-negative women aged 18 to 24 years. Participants will be randomly assigned to one of two study groups. One group will apply VivaGel™ twice a day for two weeks and the other will apply a placebo gel. The safety of VivaGel™ compared with the placebo will be assessed by laboratory tests and clinical examination of the participants.
Product acceptability assessments in the trial will provide very useful and product-specific preliminary information to add to the growing body of data supporting the attractiveness of topical gel microbicides in this consumer group.
The importance of topical microbicides is highlighted by statistics from UNAIDS and the US Centres for Disease Control and Prevention that show 48% of the 39.5 million people living with HIV/AIDS are women, and among 15- to 24- year-olds with HIV, females account for 60%. In the US, 43% of AIDS cases in
the 13- to 19-year-old age group are female.
