19th May 2016 09:23
LONDON (Alliance News) - ValiRx PLC on Thursday said its joint venture with Tangent Reprofiling Ltd, ValiSeek Ltd, had begun clinical manufacturing of its VAL401 product, to be used in a clinical efficacy trial.
The VAL401 drug is being developed for the treatment of lung cancer and other oncology indications.
ValiRx said the trial will be 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 after failure of at least one prior chemotherapeutic regimen".
To date, VAL401 oral capsules have been manufacturer at a qualified European manufacturer, which ValiRx said demonstrated suitability for progression towards a licensed product. The manufacturer is now assembling "sufficient quantity" of clinical quality VAL401 capsules to commence dosing patients in the Phase 2b trial, ValiRx said.
"Further stability assays and batch control analysis will be carried out concurrently with the manufacturing process to strengthen the package of information," ValiRx added.
Shares in ValiRx were down 20% at 10.72 pence on Thursday.
By Hannah Boland; [email protected]; @Hannaheboland
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