Melbourne, Feb 10, 2009 (ABN Newswire) - Starpharma Holdings Ltd (ASX:SPL)(PINK:SPHRY) welcomes news that PRO2000 gel, a candidate microbicide similar to Starpharma's own VivaGel(R), has demonstrated partial effectiveness in preventing HIV infection in women. The study also found that 99% of women in the trial reported that they would use a topical microbicide gel that was approved for HIV prevention.
These results are encouraging news for women seeking options to protect themselves against HIV infection. With the lack of any demonstration of efficacy with human trials of HIV vaccines, this result provides a real boost to the opportunity for topical microbicides such as VivaGel(R).
Although the result from the completed clinical study is not statistically significant and is insufficient to enable registration, it is an important milestone for the product category. PRO2000 gel was also shown to have a good safety profile, no different from the placebo. These findings are significant for Starpharma, given that the active ingredient in PRO2000 gel is in many respects similar to that of VivaGel(R).
"Given the similarity of the two products, this is excellent news for Starpharma. Importantly, VivaGel(R) has a number of differentiating factors including its activity in HIV, HSV-2 (genital herpes) and all clinically relevant strains of human papillomavirus, and its lack of absorption into the bloodstream," said CEO Dr Jackie Fairley.
The completed study also showed that another candidate microbicide, BufferGel(R), which relies on a fundamentally different mechanism of action, was not effective in reducing the risk of HIV infection.
VivaGel(R) is currently being developed under two INDs for the prevention of HIV and genital herpes and is currently in Phase 2a human trials.
These results are encouraging news for women seeking options to protect themselves against HIV infection. With the lack of any demonstration of efficacy with human trials of HIV vaccines, this result provides a real boost to the opportunity for topical microbicides such as VivaGel(R).
Although the result from the completed clinical study is not statistically significant and is insufficient to enable registration, it is an important milestone for the product category. PRO2000 gel was also shown to have a good safety profile, no different from the placebo. These findings are significant for Starpharma, given that the active ingredient in PRO2000 gel is in many respects similar to that of VivaGel(R).
"Given the similarity of the two products, this is excellent news for Starpharma. Importantly, VivaGel(R) has a number of differentiating factors including its activity in HIV, HSV-2 (genital herpes) and all clinically relevant strains of human papillomavirus, and its lack of absorption into the bloodstream," said CEO Dr Jackie Fairley.
The completed study also showed that another candidate microbicide, BufferGel(R), which relies on a fundamentally different mechanism of action, was not effective in reducing the risk of HIV infection.
VivaGel(R) is currently being developed under two INDs for the prevention of HIV and genital herpes and is currently in Phase 2a human trials.
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About Starpharma Holdings Limited
Starpharma Holdings Limited (ASX:SPL, OTCQX:SPHRY) 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.
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