04 Sep 2013, BioSpectrum Bureau , BioSpectrum
Singapore: UK-based biopharma company, Xenetic Biosciences, said in a statement that the recruitment process for the trial of ErepoXen, its early stage drug for anaemia in end stage kidney sufferers, is underway in India.
The company has specified that three patients have been screened and passed for active treatment in the 40 patient trial to test the effects of the drug.
The phase I/II study, which will assess the patient response, the pharmacokinetics and the immunogenicity of a single intravenous dose, is to be carried out by the Serum Institute of India and will take place at five sites in the country. In order to increase the rate of recruitment, more sites are expected to be added.
"Despite the trial delays in India, we now have confidence with a restructured trial that we will be able to recruit a sufficient flow of patients to establish the efficacy of ErepoXen in this important anaemia market. This trial will greatly assist Xenetic in its efforts to commercialize this potential blockbuster product in the West. We now have the primary modes of administration under way in India along with phase III predialysis in Russia and phase II approval for predialysis in Australia and New Zealand," Mr Scott Maguire, chief executive of the company said.
According to recent estimates made by La Merie Business Intelligence, successfully completing the trial will give Xenetic clinical data for the development of a range of products for global markets worth $7.2 billion.