(“ValiRx” or the “Company”)
VALISEEK CLINICAL DEVELOPMENT UPDATE
“First Verified Data Release from VAL401 Phase II Clinical Trial”
London, UK., 28 September 2017: ValiRx Plc (AIM: VAL), the clinical stage biotechnology company, is pleased to provide a positive development update on the clinical development of the joint venture between ValiRx and Tangent Reprofiling Limited.
ValiSeek was formed to progress the novel cancer treatment drug, VAL401, into Clinical Efficacy trials for the treatment of lung cancer and other oncology indications. First dosing in the Phase II clinical trial commenced in October 2016.
This update provides the first formal release of verified clinical data emerging from our trial in Tbilisi, Georgia. As reported in June 2017, we closed entry to the trial to new patients, and have since collated, verified and analysed the data collected over the first 2 weeks of all patients.
ValiSeek announces that the dosing portion of the trial is complete, with the process of final data collection, regulatory submissions for trial completion and finally for data analysis, is now underway.
The major results from this period include the pharmacokinetic measurements recorded for each patient after a single 2 mg dose of VAL401. This is carried out by a blood measurement of the active pharmaceutical ingredient in VAL401, Risperidone, and the blood measurements of the known by-product, or metabolite, of Risperidone, 9-hydroxy-Risperidone.
This analysis has revealed some significant and interesting differences between the absorption and subsequent metabolism of the conventionally formulated Risperidone, which is in line with expectations for our unique formulation. Importantly, we have demonstrated that this patient population, biologically interacts with the Risperidone in VAL401 to produce 9-hydroxy-Risperidone as expected, demonstrating suitability of our proposed treatment paradigm, as well as demonstrating that our formulation is compatible with drug absorption and behaviour.
The absolute values in this pharmacokinetic analysis allow us great confidence in our future studies, as the blood levels, even at the lowest 2 mg dosage are sufficient to mirror the doses used in the pre-clinical testing models. As 2 mg doses have been shown to be broadly safe and tolerated in this patient population, this has been nominated as the preferred dose going forwards.
ValiSeek CEO, Dr Suzanne Dilly will be attending the Bio-Europe bio-partnering conference in Berlin in November 2017 in order to partake in one to one meeting with other delegates to discuss these emerging results.
Dr Suzy Dilly, CEO of ValiSeek, commented: “It is gratifying to be able to share this early trial data release, and in particular to be able to confirm anticipated dosing levels in preparation for the next trial. The analytical databases are now being continuously populated, and I anticipate analysis from this final database to be available, on schedule, before year end.”
ValiSeek Limited (“ValiSeek”) is a joint venture (“JV”) company between ValiRx Plc and Tangent Reprofiling Limited, part of the SEEK Group. ValiSeek was formed to progress the novel cancer treatment drug, VAL401, through its remaining pre-clinical development and towards Phase II trials for the treatment of lung cancer and other oncology indications.
ValiRx is a biotechnology oncology focused company specialising in developing novel treatments for cancer and associated biomarkers. It aims to make a significant contribution in “precision” medicine and science, namely to engineer a breakthrough into human health and well-being, through the early detection of cancer and its therapeutic intervention.
* The study is conducted by Clinical Accelerator