LONDON (Alliance News) - ValiRx PLC Thursday said it has begun the regulatory process to set-up a late stage trial of its cancer treatment drug VAL401, having met with the UK Medicines and Healthcare Products Regulatory Agency in February.
Preclinical toxicology and pharmacokinetic studies of VAL401 have been completed to the required standards, and formal stability studies for the manufacturing of encapsulated VAL401 in the oral clinical format are underway.
ValiRx and the joint venture formed with Tangent Reprofiling Ltd to progress VAL401 towards clinical efficacy trials, ValiSeek Ltd, both will attend the BIO International Convention in Philadelphia in June, which will give it the chance to partner with pharmaceutical and biotechnology companies, it said.
"With clinical-based regulatory planning and documentation now commencing for VAL401, I look forward to the formal clinical trial application progressing according to schedule and building further momentum," said Chief Executive Officer of ValiZeek Suzanne Dilly in a statement.
Shares in ValiRx are trading down 1.0% at 0.208 pence Thursday morning.
By Hana Stewart-Smith; hanassmith@alliancenews.com; @HanaSSAllNews
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ValiRx (VAL)