ValiSeek Clinical Development Update

RNS Number : 0239Z

ValiRx PLC

12 December 2017

 

VALIRX PLC

("ValiRx", the "Company" or the "Group")

VALISEEK CLINICAL DEVELOPMENT UPDATE

"Positive Formal Data Release Pertaining to Disease Impact

from VAL401 Phase II Clinical Trial"

London, UK., 12 December 2017: ValiRx Plc (AIM: VAL), the clinical stage biotechnology company, is pleased to provide a positive update on the clinical progress of VAL401, the anti-cancer compound developed by ValiSeek, the joint venture between ValiRx and Tangent Reprofiling Limited. 

Further to the release of pharmacokinetic data from the completed Phase II clinical trial in Tbilisi, Georgia (as announced on 28 September 2017), the Company is pleased to now announce the positive formal data release pertaining to disease impact.  The results demonstrate that the VAL401 treatment has a statistically significant improvement in Overall Survival ("OS") for patients with non-small cell lung cancer compared to those receiving no treatment.

This data has been summarised and published in our updated information sheet available at: http://www.valirx.com/in-the-news/valiseek-val401-novel-cancer-therapeutic-updated/

Scientific Summary:

All data collected during the clinical trial of VAL401 in Tbilisi, Georgia, which completed earlier this year, has now been fully verified and the database has been locked against further modifications. The data analytics team at Ariana Pharma (the company appointed to undertake clinical data analysis of the data gathered during the trial) has received the full database and started its formal analysis. Furthermore, Ariana Pharma is characterising the best responders to VAL401 using their proprietary KEM® (Knowledge Extraction and Management) advanced artificial intelligence technology.

In addition to the data collected throughout and beyond dosing of the VAL401 treated patients, historical data from the clinics in Tbilisi has been collected in order to benchmark our patients.  These patients would have been eligible for the trial, but either declined consent or were treated in the clinic at a time that recruitment was not open in our trial.  Although not a placebo group, these patients provide a comparison group to indicate how long our patients may have expected to survive without the VAL401 treatment.  Data consisting only of date of  first and last chemotherapy prescription and date of death is available for all untreated patients.  This allows a valuable comparator group for survival analysis.

Comparing the OS rates of treated patients to untreated patients and measuring from the date that patients received their first course of chemotherapy for non-small cell lung cancer until the date of death, VAL401 treatment provides a statistically significant (p = 0.0109 log likelihood ratio) improvement in survival.

Further analysis of the other endpoints, including Quality of Life, is underway at Ariana along with systematic scrutiny of underlying factors.  These dictate the response or non-response of patients to treatment, using Ariana's KEM® platform. The use of this technology aims to increase the chances of success in subsequent trials through informed patient selection.

Commercial Summary:

Further to our announcement of 11 October 2017, we confirm that the allowed US patent has now been fully granted with Number: US 9808462.

VAL401 has been tested in the above mentioned trial against non-small cell lung cancer, the most common form of lung cancer.  The lung cancer market, with significant unmet medical need, is projected to be valued at USD 7.9 billion in 2020 at a CAGR of 6.6%.  The Company is in discussion with a number of large pharmaceutical companies who are looking to fill their pipelines in this therapeutic area.

Dr Suzy Dilly, CEO of ValiSeek, commented: "I am delighted to confirm that our patients benefitted in overall survival, with the other measures of disease impact still to be analysed and presented.  The team at ValiSeek, Ariana and ValiRx have been instrumental in ensuring this data is presented and interpreted fully and I look forward to updating the market with the next report instalment".

This announcement contains inside information for the purposes of Article 7 of EU Regulation 596/2014.

*** ENDS ***

For more information, please contact:

ValiRx plc	Tel: [phone] www.valirx.com
Dr Satu Vainikka, Chief Executive	Tel: [phone]
Tarquin Edwards, Head of Communications.	Tel: [phone] [e-mail]
Cairn Financial Advisers LLP (Nominated Adviser) Liam Murray/Jo Turner/Richard Nash	Tel: [phone]
Beaufort Securities Limited (Broker) Jon Belliss	Tel: [phone]

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

 

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