Particle Sciences to share responsibilities in developing anti-HIV microbicides

Particle Sciences, a leading drug development CRO, will share formulation, analytic and production responsibilities in an effort to develop a vaginally administered microbicide, a product specifically designed to prevent the sexual transmission of HIV.  According to Robert Lee, VP Pharmaceutical Development at Particle Sciences, "Particle Sciences is well qualified for this challenge having extensive expertise in mucosal formulation and previous experience with similar products.  We have been developing vaginal gels and sustained delivery systems such as intravaginal rings for some time now and are thrilled to be able to leverage that experience on behalf of Combined Highly Active Anti-retroviral Microbicides program (CHAARM)".  According to Charles Kelly of King's College London, CHAARM's coordinator, "We are very pleased to be working with Particle Sciences.  Their unique expertise in formulation of compounds for mucosal application will be essential to the success of the program."

"It's a real honor to be able to work on such projects with such a distinguished international team and we are deeply appreciative of the funding provided by the European Commission for this work," said Lee.

The CHAARM project aims to develop new anti-HIV microbicides – products that could reduce the transmission of HIV by sexual intercourse.  Microbicides could be applied in the form of a gel, cream or a controlled-release device to prevent infection with HIV at vaginal or rectal surfaces.  CHAARM will focus on combination products containing two or more microbicides in a single product which will be more effective than using a single microbicide.

The project involves scientists with expertise in a wide range of different disciplines bringing together 31 institutions (Universities, Small and Medium Enterprises, Research Institutes, Pharmaceutical Companies and Microbicide Developers) in 12 countries, including 8 EU Member States, as well as Switzerland, South Africa, the United States of America and Ukraine.  The program will include human studies to determine microbicide safety and will investigate biomarkers associated with health or damage at mucosal surfaces.  It will also encompass formulation development and manufacturing process scale-up of the drug product.