ValiSeek, a joint venture between ValiRx, a clinical stage biotechnology company and Tangent Reprofiling Limited, plans to add a third clinical site for clinical trial of cancer drug VAL 401, in Tbilisi, Georgia.
ValiSeek was formed to progress VAL401, into Clinical Efficacy trials for the treatment of lung cancer and other oncology indications.
The company’s second trial site has been approved by the Ministry of Health, Georgia, and it is actively recruiting patients into the trial. ValiSeek said on Wednesday it has received approval from the ethics committee of the Research Institute of Clinical Medicine, Tbilisi for its third site, and is in the process of submitting an application for full regulatory approval from the Ministry of Health.
The third site is expected to start recruiting patients by April 2017. The company said it will extend its recruitment period into Q2 2017.
In addition, ValiSeek said it has received approval of several protocol and documentation amendments and updates both to the ethics committees of all three sites and to the Ministry of Health, Georgia.
Dr Suzy Dilly, CEO of ValiSeek, said: “The set-up and planning for the addition of a third site is a statement of confidence and evidence that we are all working towards completing recruitment and collecting good quality data within a reasonable timeframe. I thank the team at Clinical Accelerator for achieving this. The amendment for preliminary datalock is important as it allow us both to access early data from the trial and to conduct a robust analysis of the early safety, tolerability and pharmacokinetic data, but without compromising the quality of life and survival data that will continue to be gathered”.