ValiRx Plc (LON:VAL) – CORP*: Clinical development update
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Ethics Committee Approval Received for VAL401
ValiRx issued an update on the clinical development of its cancer treatment drug, VAL401.
The group confirmed that it has received a positive opinion recommending approval of the trial protocol from the Ethics Committee covering its clinical site in Tbilisi.
This opinion will now be combined with extensive documentation on the planned trial for its final submission to the Competent Authority in Georgia for the regulation of clinical trials.
If the final submission to the Georgian Competent Authority is positive, ValiSeek would then have necessary consents to launch the clinical trial site.
The proposed trial is labelled: "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".
ValiRx also confirm that the first batch of the VAL401 capsules for use in the trial has completed primary manufacture. The capsules are now undergoing final quality control procedures before shipment to Tbilisi for patient dosing.
NORTHLAND CAPITAL PARTNERS VIEW: Receiving ethics approval is a significant step in the regulatory process prior to patient recruitment and dosing—it is a precondition in the Georgian regulatory approval process. As such, ValiRx is a step closer to dosing patients in its VAL401 programme. The commencement of this trial will be a major milestone for ValiRx, as it will move the group’s second programme into the clinic.