ValiRx Regulatory News (VAL)

VALIRX PLC

("ValiRx" or the "Company")

 ENHANCEMENT OF THE VAL201 DOSE ESCALATION CLINICAL STUDY

"Approval received from the UK Medicines and Healthcare Products Regulatory Agency ("MHRA")

and the Research Ethics Committee ("REC")"

London, UK., 18 December 2017: ValiRx Plc (AIM: VAL), the clinical stage biotechnology company, is pleased to announce that the Company has received approval from the MHRA and REC for the Company to expand its VAL201 trial for the Phase I/II Dose Escalation Study in Patients with Locally Advanced or Metastatic Prostate Cancer and other Advanced Solid Tumours.

VAL201 has demonstrated consistently high safety and tolerability, as well as preliminary effectiveness throughout the clinical study. Following the successful completion of this stage one of clinical development, with no serious drug related adverse events noted, the MHRA and REC have accepted the Company and clinical team's request for this escalation to the study. This approval allows for a substantial increase in the dose of VAL201 being administered to patients, thereby allowing treatment to more speedily reach its full therapeutic potential and potential anti-cancer impact. Further analysis will be provided in due course following a more comprehensive evaluation of the data.

This regulatory approval permits ValiRx to;

· To substantially raise the dosing level in patients in order to reach therapeutic levels and reduce disease progression; 

· To assess at what stage in disease development the compound can be most effectively deployed in subsequent, larger, outcome-oriented clinical trials; and

· To determine which route and with whom to take the project to its next stage - by the Company or with a partner.

VAL201 has the potential to target hormone induced oncological conditions and abnormal growths, including prostate, breast and ovarian cancers as well as endometriosis. VAL201 is currently in Phase I/II clinical trials at UCLH for prostate cancer. The compound has also shown effects against Endometriosis in pre-clinical studies. The VAL201 treatment is differentiated from current advanced prostate cancer therapies, by not including complete and general androgen hormone deprivation.

The molecule is a peptide that inhibits the interaction between the androgen receptor and/or the oestrogen receptor complex with Src Kinase complex Domain 3. This very specific mode of action has been shown in pre-clinical studies to provide a potent therapeutic benefit with fewer side effects compared to the standard hormone therapy. VAL201 is potentially and uniquely able to treat prostate cancer without many of the other debilitating side effects associated with other therapies.

The Prostate cancer market is expected to rise to $8.2 billion in 2023 and the endometriosis market to $2billion by 2025. (Global Data)

ValiRx retains control of all commercial rights to the compound and maintains an extensive patent portfolio covering the compound and its use and development.

Dr Satu Vainikka, CEO of ValiRx, commented: "Successfully reaching the endpoints in VAL201 clinical studies and receiving the approval for the acceleration of the trial and to substantially escalate the dose, is a pivotal and substantial breakthrough for our lead compound. Since VAL201 has demonstrated disease stabilisation, with a lower dose than was predicted, we anticipate that by increasing the dosage we will be able to see further anti-cancer activity. This accelerated study will speed-up the human development of the compound and by doing so, it will save both time and money. Most importantly, this potential treatment will more speedily meet the needs of those patients currently under-served by existing therapies. The pharmaceutical industry is increasingly looking for novel new therapies in the oncology arena. We are entering a new and very exciting phase, which should result in the crystallisation of substantial value".

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

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Notes for Editors

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 Word 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.