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news.Biotechnology company Avexa has received positive feedback from both North American and European regulatory authorities allowing immediate progression into a Phase III program of apricitabine for the treatment of drug-resistant HIV patients.
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Avexa will move forward with two pivotal clinical trials which have been reviewed and will form the basis for future approval. The end point of the trials will be the percentage of patients that reach less than 400 copies of the virus per milliliter of blood after 24 weeks. The start dates of the trials will be staggered as the company is required to assess two dose levels in the first trial to confirm the optimum dose.
The second trial will study the optimum dose only. The patient population and clinical end points will be very similar to those of the current Phase IIb 24-week timepoint, the results of which were announced in September 2007. Avexa further advised that there are now 37 patients on the Phase IIb extension study, with some patients having been treated with apricitabine (ATC) for over two years.
Julian Chick, CEO of Avexa, said: “We have plenty of work ahead of us but we have a clear path forward towards approval and subsequent marketing of ATC. Furthermore, we are encouraged by the very positive results from the 24-week study, which have direct relevance to the planned Phase III studies.
“In addition, the number of patients requesting to continue ATC treatment gives us further confidence that ATC is providing patients with an effective new treatment in the fight against HIV and making a significant difference to their lives.”