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LONDON (Alliance News) - ValiRx PLC said on Thursday it received a positive opinion on the clinical development of its new cancer treatment drug, VAL401, from a Georgian Ethics Committee.
The Ethics Committee covering its clinical site in Tbilisi recommended approval of a clinical trial, a significant step in the Georgian regulatory approval process prior to patient recruitment and dosing. The company will now submit documentation for the regulation of clinical trials.
If the final submission to the Georgian Competent Authority is positive, the company would have the necessary consent to launch the clinical trial site and import the test drug.
The company said the first batch of VAL401 capsules for use in the potential trial have completed primary manufacturing.
It has been a year since ValiRx first announced the commencement of the clinical process for the testing of VAL401 in the treatment of patients with lung cancer.
Shares in ValiRx PLC were up 1.6% Thursday morning at 7.37 pence.
By Lucy Heming; lucyheming@alliancenews.com
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