VALIRX PLC
("ValiRx", the "Company" or the "Group")
VALISEEK CLINICAL UPDATE (VAL401)
"Positive Impact of Patient Quality of Life and Immune Competency
in VAL401 Phase II Clinical Trial"
London, UK., 16 January 2018: 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.
|
PFS mean (range) |
OS mean (range) |
Responders (n=3) |
8.7 weeks (7.1 - 11.6) |
12.9 weeks (11.6 - 15.3) |
Non-responders, intention to treat population (n=4) |
2.5 weeks (0.4 - 4.7) |
3.9 weeks (0.4 - 7.4) |
Non-responders, per protocol population (n=2) |
4.3 weeks (4.0 - 4.7) |
7.1 weeks (6.8 - 7.4) |
These results identify an overall response rate in the per protocol population of 60%.
Biochemical Response
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."
This announcement contains inside information for the purposes of Article 7 of EU Regulation 596/2014, and the person who arranged for release of this announcement on behalf of the Company was George Morris, Chief Operations Officer.
*** ENDS ***
For more information, please contact:
ValiRx plc |
Tel: +44 (0) 20 3008 4416 www.valirx.com |
Dr Satu Vainikka, Chief Executive |
Tel: +44 (0) 20 3008 4416 |
Tarquin Edwards, Head of Communications. |
Tel: +44 (0) 7879 458 364 [email protected] |
|
|
Cairn Financial Advisers LLP (Nominated Adviser) Liam Murray/Jo Turner/Richard Nash |
Tel: +44 (0) 20 7213 0880 |
|
|
Beaufort Securities Limited (Broker) Jon Belliss |
Tel: +44 (0) 207 382 8300 |
Notes for Editors
About ValiSeek
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 drug VAL401 through its remaining preclinical development and towards Phase II trials for the treatment of lung cancer and other oncology indications.
About ValiRx
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 Company's business model focuses on out-licensing therapeutic candidates early in the development process. By aiming for early-stage value creation, the company reduces risk considerably while increasing the potential for realising value. The group is already in licensing discussions with major players in the oncology field.
ValiRx's two classes of drugs in development, which each have the potential for meeting hitherto unmet medical needs by existing methods, have worldwide patent filings and agreed commercial rights. They originate or derive from World class institutions, such as Cancer Research UK and Imperial College.
Until recently, cancer treatments relied on non-specific agents, such as chemotherapy. With the development of target-based agents, primed to attack cancer cells only, less toxic and more effective treatments are now possible. New drugs in this group-such as those in ValiRx's pipeline-promise to greatly improve outcomes for cancer patients.
The Company listed on the AIM Market of the London Stock Exchange in October 2006 and trades under the ticker symbol: VAL
About Ariana Pharma
Ariana® Pharma is a leading digital health Company focused on developing advanced therapeutic decision support systems. Ariana's innovative clinical data analysis and diagnostic testing solutions help the healthcare sector better adapt patient treatments to individual biological characteristics. Ariana's KEM® Artificial Intelligence technology enables personalization of therapies, improves the efficacy and safety of patient treatment, reduces risks and drug development costs, and accelerates time to market. KEM® is the only FDA - tested technology that systematically explores combinations of biomarkers, producing more effective biomarker signatures for precision medicine. Ariana has developed Onco KEM®, the most advanced, clinically tested, oncology treatment selection system. Founded in 2003 as a spin - off of the Institut Pasteur, Paris, France, the company opened a subsidiary in the United States in 2012. Further information is available at www.arianapharma.com
