VAL201 Clinical Trial Full Data Results

Full dataset confirms VAL201 is a safe and well-tolerated drug candidate

Company to host webcast for investors on 8 December 2020 at 2 pm GMT

London, UK - ValiRx plc (“ValiRx”, AIM:VAL), a clinical stage drug development company, is pleased to report that it has received the full dataset to be used for the Clinical Study Report from the Phase 1/2 clinical trial of its lead asset, VAL201, for the treatment of locally advanced or metastatic prostate cancer and performed at University College Hospital (UCLH), London. This expands the positive headline results announced on 28 September 2020.

The dataset provides a complete breakdown of the full data of safety and tolerability as well as evidence for encouraging disease impact as observed during the clinical trial.  This data will be used to formulate the Clinical Study Report and to report the results on the www.clinicaltrials.gov database.  Additional detailed analysis of the results will form the basis of peer-reviewed journal publications.

The full dataset is available to download on the Company website, https://www.valirx.com/our-pipeline/val201.

Key details of the findings:

Recruitment Criteria

• Twelve patients were recruited according to the criteria of having incurable, locally advanced or metastatic prostate cancer with rising PSA[1] (Prostate-Specific Antigen) on three consecutive samples and absent or very mild prostate cancer-related symptoms.
• The demographics and a detailed breakdown of the patients recruited is provided in the download.

Disease Impact

• The headline results released in the Company announcement on 28 September 2020 highlighted the response rate of 54.5%, where response was confirmed by a lack of disease progression by PCWG2 (Prostate Cancer Working Group 2) criteria.  The dataset now received provides the detailed breakdown of this by providing both the PSA modulation afforded by the treatment, and the tumour response.
• The PSA data, a recognised surrogate of disease progression, shows two patients seeing a decrease in PSA during their treatment period, one of which maintained the decrease throughout the trial. An analysis of the doubling time of patients shows a statistically significant (p<0.05, two-tailed Wilcoxon Signed-Rank test for paired samples) increase in PSA doubling time comparing pre-treatment doubling time to post-treatment doubling time.  The PSA doubling time would be expected to be unchanged if the treatment was having no impact, so an increase in doubling time demonstrates a slowing rate of growth of PSA levels.
• The tumour response data demonstrates that patients did not have an increase in metastatic lesions during the treatment period, and that metastatic lesions already present did not grow at all in two out of three patients, suggesting a positive influence of VAL201 on the disease.

Safety and Tolerability

The further breakdown of the safety data confirms the well tolerated nature of the drug.

Additionally, the initial pharmacokinetic analysis supports the safety profile in confirming the drug is processed and cleared from the body in the manner expected.

The Company expects to publish the data on the National Institute of Health’s (NIH) public database ClinicalTrials.gov, as well as produce research papers for peer-reviewed publications.

Investor Webcast

ValiRx will host a webcast for investors on Tuesday, 8 December 2020 at 2pm GMT to discuss the findings of the study.

• Prior to the webcast, questions can be submitted online to questions@valirx.com
• During the webcast, questions can be submitted through the webcast link below.

To participate, please click on the link below at the designated time:

https://webcasting.brrmedia.co.uk/broadcast/5fc12476b19325729a9d841f

The webcast will be available on demand following a link on the Company’s website after the broadcast.  This webcast replaces the usual monthly Q&A publication, and a written summary of questions with answers will be provided after the event.

Dr Suzy Dilly, Chief Executive Officer commented: “This data demonstrates the potential of VAL201 for further development towards a treatment for patients with prostate cancer.  Providing the data breakdown to support and explain the headline numbers is a crucial step and allows us to delve further into analysis of the results. The highly encouraging 54.5% response rate remains unchanged and being able to interrogate the data in more detail allows us to explore the possibilities for optimising the treatment through future trial with partners.

“We continue to share the dataset with potential industry partners who expressed an interest after the headline results were released in September 2020, and I look forward to the discussions that I am confident will arise as we evaluate all options for further clinical development.  We would like to thank the team for their hard work and our shareholders for their support.”

This announcement contains inside information for the purposes of Article 7 of EU Regulation 596/2014. The Directors of the Company take responsibility for this announcement.

[1] The PSA test is a blood test used primarily to screen for prostate cancer. The test measures the amount of prostate-specific antigen (PSA) in the blood. PSA is a protein produced by both cancerous and noncancerous tissue in the prostate gland.