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ValiRx issues ValiSeek clinical development update

By BFN News | 07:47 AM | Thursday 14 July, 2016

ValiRx said ValiSeek has received a positive opinion recommending approval of the trial protocol for VAL401 from the Ethics Committee covering its clinical site in Tbilisi. It said this was a "significant step in the regulatory process prior to patient recruitment and dosing." Approval from the Ethics Committee is a precondition and integral element in the Georgian regulatory approval process. It is 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. This opinion will now be combined with ValiSeek's extensive documentation on the planned trial and on the drug capsule manufacture, 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 and to import the test drug, VAL401; ValiSeek is a joint venture between ValiRx and Tangent Reprofiling. It was formed to progress VAL401 toward clinical efficacy trials for the treatment of lung cancer and other oncology indications. Story provided by

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