Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.Indevus Pharmaceuticals has completed enrollment in Protocol MDP 301, a Phase III clinical trial of PRO 2000, the company's vaginal microbicide candidate for the prevention of HIV and other sexually transmitted infections.
Subscribe to our email newsletter
MDP 301 is a multi-national, randomized, double-blind, placebo-controlled Phase III trial designed to examine the safety and effectiveness of PRO 2000 in preventing HIV infection in women. The trial will also assess effects on other sexually transmitted infections including herpes, chlamydia and gonorrhea.
This is said to be the second large trial testing the safety and effectiveness of the 0.5% dose of PRO 2000 and the largest trial of any microbicide to date.
The trial is sponsored by the UK’s Medical Research Council and conducted by the Microbicides Development Programme, an international partnership of researchers established to develop microbicides for the prevention of HIV transmission.
This trial enrolled 9,395 women at clinics in South Africa, Tanzania, Uganda, and Zambia. Results from this trial are expected to be available by the end of 2009.
Glenn Cooper, chairman and CEO of Indevus, said: “We have now completed enrollment in two pivotal trials with over 12,000 women participating. If the trials are successful, we expect to be in a position to file marketing applications with regulatory authorities, including a new drug application with the FDA, in 2010.”