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/
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.
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”.
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