ValiRx (LON:VAL) – CORP: Clinical development update
Market Cap: £4.4m; Current Price: 7.75p
Notification to progress VAL401 clinical trial
ValiRx issued an update on the clinical development of its cancer treatment drug, VAL401, on the back of receiving approval of the trial protocol in mid-July from the Ethics Committee, covering its clinical site in Tbilisi.
The group today confirmed that it has received notification of acceptance by all required Regulatory Authorities in Georgia of the protocol and associated documentation for the Phase IIb Clinical Trial of VAL401.
The approved protocol lists "Tumour progression-free survival" as the primary endpoint. This will record the length of time between patient screening and progression of the disease, providing a first indication of whether the treatment will be efficacious. Secondary endpoints include pharmacokinetic measurements; safety and tolerability of the drug; quality of life of the patients and overall survival, providing supporting data on efficacy and drug dosing parameters, which are key to aligning the programme with industry expectations. The protocol details the dosing and testing schedules to be carried out on each patient for six months treatment, with a maximum of twenty patients to be fully enrolled, with recruitment staggered over a number of months to ensure patient safety.
Clinical Accelerator, the UK-based clinical trial management organisation engaged by ValiSeek, as previously announced, will be building on their work of achieving this regulatory approval by coordinating the operational and logistical functions of the clinical trial.
NORTHLAND CAPITAL PARTNERS VIEW: This is a significant step and a major milestone in the process for the VAL401 project. Dr Suzanne Dilly, CEO of ValiSeek Limited, commented: “It is very satisfying to have received confirmation from the regulatory experts that the trial has been correctly constructed and that the process of selecting patients for dosing can begin. After several years of preparation and pre-clinical testing, it is exciting to know that we can expect results to start arriving in the coming months”.