The success of its clinical trial for lead candidate VAL201 in prostate cancer means the study is to be expanded, biotech ValiRx Plc (LON:VAL) said today.
The number of patients will be lifted and new study centres included, the firm told investors in a fourth quarter update on progress.
The trial is a phase I/II dose escalation study to assess safety and tolerability of the drug for prostate cancer and other solid tumours.
The first cohort of patients were given 0.5 mg/kg of the compound and this was increased to 5.0mg/kg over 5 cohorts, dose levels (DL).
No dose limiting toxicity (DLT) has been observed to date, nor have any therapeutically related serious adverse events (SAE).
Mild fatigue and temporary injection site rashes are the only adverse events seen so far.
The conclusion so far is that VAL201 has met and exceeds the predicted safety and tolerability criteria set for the trial.
Meanwhile, earlier this month there were encouraging early findings from the Phase II clinical trial of VAL 401 - the firm's lung cancer candidate, with a first patient progressed through the dosing phase and a second approved to start.
These two patients are continuing on the trial and although full pharmacokinetic interpretation will be carried out only when all 20 patients have data, initial analysis shows the levels of active drug and known metabolite to be present in blood samples are as expected.
The quarter also saw the group receive notification that a third US patent had been allowed covering VAL401 in the treatment of lung adenocarcinoma.
And since then, a fourth US patent grant allowance for VAL401 has been received.