ValiRx Plc (LON:VAL) shares jumped higher on Thursday on news the firm has been given regulatory clearance to increase the dose of its VAL201 drug following an amendment to the clinical trial it is currently carrying out.
The first-in-human study of men suffering prostate cancer has revealed the safe toxicological limits are higher than suggested by pre-clinical assessments of the compound.
“The approval given to relax the restrictions previously applied to the trial, mean that a more effective use of VAL201 can be achieved, with respect to concentration and timing and regarding increased flexibility in the administration of the drug,” investors were told.
The changes to dosing strategies, signed off by the Medicines and Healthcare products Regulatory Agency, will allow researchers to develop further clinical trial protocols that are being designed to identify the most effective approach to treating patients.
Thus far, VAL201 has met the goals for this early-phase trial, which is designed to assess whether the compound is safe and well tolerated. The company said results on both scores continued to be “acceptable”.
Moreover, it has seen “further evidence of the compound's positive effect in reducing the progress of prostate cancer”.
The data from the trial is currently being collated for examination by independent experts and results will be available in “due course”, ValiRx said.
The firm’s chief operating officer, George Morris, added: “Now, as the trial is delivering an extensive and positive output, it is also providing practical information back to the trialling of VAL201, so that the next stage of clinical development, in which we will endeavour to show how effective the compound actually is, can be entered into with confidence and support from all those involved."
In the same announcement, ValiRx said Dr Mark Linch had been appointed as principal investigator to its clinical trial team at University College London Hospital.
He is a consultant medical oncologist specialising in the treatment of prostate and bladder cancer.
In opening deals, ValiRx shares were 25% higher at 0.295p.
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