ValiRx provides a development update on the clinical development of ValiSeek, the joint venture between ValiRx and Tangent Reprofiling Ltd.
ValiSeek was formed to progress the novel cancer treatment drug, VAL401, into Clinical Efficacy trials for the treatment of lung cancer and other oncology indications.
Further to our announcement on 3 November 2016 regarding the successful dosing of the first patient with VAL401, ValiSeek is pleased to confirm the initiation of the process to commission a second clinical testing site under our protocol VAL401-001 "A Phase II study to assess the efficacy, safety and tolerability of VAL401 in the treatment of patients with locally advanced or metastatic Non-Small Cell Lung Cancer (NSCLC) after failure of at least one prior chemotherapeutic regimen".
As part of this process, the protocol and supporting documentation have been reviewed by the ethics committee at the second Tbilisi site, the JSC Neo Medi Clinic, and they have now returned a positive opinion and approval.
This opinion will now be submitted to the Georgian Competent Authority for the regulation of trials, the Ministry of Labour, Health and Social Affairs of Georgia. This regulatory step will allow the set-up of the new clinical trial site and enable the clinical team to begin identifying further patients for recruitment into the trial.