ValiRx (LON:VAL) – CORP*: VAL401 development update
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VAL401 a step closer to the clinic
ValiRx issued a development update on its second upcoming clinical programme, VAL401, a novel lung cancer treatment (and for the treatment of other oncology indications).
Today ValiRx confirmed the initiation of the clinical manufacturing of the Investigation Medicinal Product (IMP), VAL401, for its use in the clinical trial: "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".
To date, VAL401 oral capsules, in both 1 mg and 5 mg dose strengths, have been manufactured at a qualified European manufacturer; demonstrating suitability for progression towards a licensed product.
The manufacturer is now assembling sufficient quantity of clinical quality VAL401 capsules to commence dosing patients in a Phase 2b trial.
Further stability assays and batch control analysis will be carried out concurrently with the manufacturing process to strengthen the package of information.
NORTHLAND CAPITAL PARTNERS VIEW: After today’s announcement, ValiRx is a step closer to commencing its second clinical programme, VAL401. With manufacturing lined up, sufficient clinical trial supplies should soon be ready to commence dosing patients. Due to VAL401’s established safety profile, ValiRx expects to fast-track the programme straight into a Phase 2b trial.