ValiRx Plc (AIM: VAL), the clinical stage biotechnology company, is pleased to provide an update on the clinical progress and results of VAL401, the anti-cancer compound developed by ValiSeek, the joint venture between ValiRx and Tangent Reprofiling Limited.
Following on from the announcement on 12 December 2017 regarding the overall survival results from the completed Phase II Clinical Trial of VAL401 in Tbilisi, Georgia, in the treatment of late stage non-small cell lung cancer, the Company is pleased to release further positive data on the results from this trial. The data analysed by Ariana, a leading digital health Company focused on developing advanced therapeutic decision support systems, shows that the VAL401 treatment has a measureable improvement on patient quality of Life, in addition to a positive impact on the disease.
The one page information sheet available on the website has now been updated, and can be viewed at: http://1cqi8a4dpf4p8okqjp35hmi5.wpengine.netdna-cdn.com/wp-content/uploads/2018/01/VS-Jan-2018-one-pager.pdf
Detailed technical reports are currently being prepared for submission to the regulatory authorities. Subsequent data release will be in the format of peer-reviewed publications in academic journals to ensure that the data is subject to long-term accessibility and will be available on publicly searchable databases. Clinicaltrials.gov will be updated upon agreement with the regulatory authorities of the Clinical Study Report.
Response for the treatment has been systematically characterised using Ariana’s KEM® (Knowledge Extraction and Management) advanced Artificial intelligence technology to identify provide positive relations between response and pharmacokinetic parameters and between response and pre-treatment with particular chemotherapies. This may be indicative of the potential for combining VAL401 with these particular chemotherapies.
Progression Free Survival
Progression-free survival (“PFS”) was defined as the length of time between initiation of VAL401 treatment and a patient’s removal from the trial or death (whichever is sooner) and considered as a comparison of responders to non-responders. In order to characterize responders, the definition of the Overall Survival (“OS”) was shortened to the length of time between the initiation of VAL401 treatment and death.
PFS and OS are presented in the table below, with the time represented as day zero and being the first day of VAL401 treatment. The mean values quoted represent an additional one month or longer of PFS and OS after response to VAL401 treatment.
The “intention to treat” population incorporates all patients under survival assessment; the “per protocol” population incorporates all patients who received a minimum of 10 days dosage. Responders were identified by Ariana’s KEM® technology using survival data.
These results identify an overall response rate in the per protocol population of 60%.
Blood biochemistry was measured in all patients at regular intervals during the on-trial period. This data was included in Ariana’s exhaustive data analysis and it was observed that the White Blood Cell Count (WBC) in 3 patients increased during the trial. Two of the responders were subject to a sustained increase in WBC, and one non-responder increased WBC on trial initiation before the WBC returned to baseline.
A WBC increase is indicative of increased immune system activity. The increase seen during our trial suggests that VAL401 does not cause immune suppression, which is common in traditional chemotherapies. It therefore makes it appropriate for considering the testing of VAL401 in co-administration with Immuno-oncology treatment.
Quality of Life data
Quality of Life questionnaires were carried out at regular intervals while the patients were on-trial. Nineteen factors improved from baseline to trial end in several patients. Other factors improved briefly before returning to baseline as the disease approached the time of progression. These included one patient that reported improved appetite (and showed a bodyweight gain throughout the trial), one patient reporting improvement in depression and another an improvement in irritability. Two responders reported an improvement in ability to take part in leisure activities.
Ariana’s KEM® systematic analysis of the Quality of Life improvements identified relations providing further insight into VAL401:
· Multiple patients reported an improvement in pain, which on comparison to pharmacokinetic parameters was linked to high exposure to VAL401.
· Improvement in fatigue was associated with lower exposure.
· Patients regardless of responder status reported improvements in Quality of Life measures suggesting palliative effects of VAL401 treatment. Responders additionally observed anti-cancer (survival) benefit.
Dr Suzy Dilly, CEO of ValiSeek, commented:
“This data advocates the potential for VAL401 in treating very late stage cancer patients in the palliative arena. It also advocates the potential for VAL401, in the as yet untested combinations with, both traditional chemotherapies and immune-oncology treatments. Palliative stage patients could expect to see improvements in symptoms with the added benefit of improved survival prospects. This encouraging 60% overall response rate seen in this first all-comer trial, provides a strong foundation for the next stage of clinical testing. The measure of immune competency of the treated patients was also a pleasingly unexpected addition to the results. In sum, we are very excited to see such good response rate for a condition with huge unmet medical need.”
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