LONDON (Alliance News) - ValiRx PLC on Thursday said it still expects the first results from the VAL201 study to come in the first quarter of this year and said it is in talks with regulators on progressing its VAL401 product to a formal clinical trial.
ValiRx said it expects data from the first study on VAL201, being conducted at University College London Hospital, to come in the first quarter.
The phase I/II trial is a dose escalation study to assess the safety and tolerability of the compound in patients with locally advanced or metastatic prostate cancer and other advanced solid tumours.
Its VAL401 compound is a reformulation of a generic drug which has been used for the treatment of an unspecified central nervous system disease. The toxicology studies on VAL401 have been completed, with no adverse impact reported.
Further analysis of the data has completed the pre-clinical regulatory packages, which include pharmacokinetics, drug distribution and exposure, ValiRx said.
The company is now seeking advice from the Medicines and Healthcare Products Regulatory Agency with a view to progressing VAL401 into a pivotal formal clinical trial regarding its efficacy in treating cancer.
A clinical biomarker for the identification of patients appropriate for treatment with VAL401 has been proposed and work has been commissioned through ValiRx's ValiFinn Oy subsidiary to establish and validate this methodology, it added.
"We have seen a significant period of progress for ValiRx over the past twelve months, with our lead compound VAL201 having advanced into patient clinical trials and with our portfolio of other drug candidates also seeing encouraging progress," said ValiRx Chief Executive Officer Satu Vainikka.
"With recent developments, ValiRx is now well placed to execute its future clinical plans and build itself a strong position addressing the challenge and treatment of cancers," Vainikka added.
ValiRx shares were up 2.8% to 0.257 pence on Thursday.
By Sam Unsted; samunsted@alliancenews.com; @SamUAtAlliance
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