Date: 2015-11-04
Type of information: Publication of results in a medical journal
phase:
Announcement: publication of results in Bioanalysis
Company: Acucela (USA - MA)
Product:
Action mechanism:
Disease:
Therapeutic area: Ophtalmological diseases
Country:
Trial details:
Latest
news: * On November 4, 2015, Acucela announced that the company has validated an analytical method that could lead to significant cost savings in the collection of blood samples as part of the company’s clinical trials of emixustat hydrochloride (emixustat). Emixustat is in development for the treatment of geographic atrophy (GA). The long-term clinical safety and efficacy of emixustat is being evaluated in an ongoing phase 2b/3 study. Acucela had an article published in a recent issue of Bioanalysis showing promising results for the collection of human dried blood using a newly invented, patent pending Mitra™ VAMS™ (volumetric absorptive microsampling) device from the company Neoteryx. VAMS is a novel approach for obtaining dried biological fluids for quantitative bioanalysis, without volumetric hematocrit bias, that collects a fixed amount of blood (e.g. 10 microliters) following a fingerprick or other method for obtaining low volumes. The company’s study validated the VAMS method for the bioanalysis of emixustat in human blood. This method is being tested in bridging studies to confirm if the Mitra VAMS device can be used in late-stage clinical trials of emixustat. The VAMS collection method, using dried blood instead of wet blood, could be more efficient and economical than the traditional method of collecting plasma samples – and not just in the testing of emixustat. Since VAMS uses dried blood, shipping and handling costs of samples are much lower, and samples can be collected in more varied and remote locations than a research lab or hospital.
