Headline results demonstrate VAL201 has potential to be a safe and well-tolerated drug
London, UK ValiRx (AIM:VAL) reports today that it has received headline results from the recently completed Phase 1/2 clinical trial of its lead asset VAL201, for the treatment of advanced prostate cancer, held at University College Hospital (UCLH), London.
The headline results, detailed below, provide a summary of the top-level data of safety and tolerability as well as evidence for disease impact as observed during the clinical trial. Full data and details of from the clinical trial are expected to be received by the Company by end Q4 2020.
Disease Impact – Overall Response Rate 54.5%
Evidence for positive disease impact has been measured using PCWG2 (Prostate Cancer Working Group 2) guidelines. These industry standard guidelines take into account both the primary tumour and metastatic tumours alongside prostate specific antigen (PSA) levels to assess whether the disease has progressed, or whether the patient has responded and halted disease progression. These guidelines provide a more comprehensive measure of disease impact than just primary tumour imaging.
Of the 12 patients dosed with VAL201, 11 patients had sufficient PCWG2-relevant data collected across multiple cycles. 6 of these 11 have been categorised as responding throughout treatment. That is, when the treatment with VAL201 was halted for a defined reason, whether or not the 6 standard cycles had been completed, these patients showed no disease progression by PCWG2 criteria with stable disease.
Safety and Tolerability – no Maximum Tolerated Dose declared
As the first clinical trial of VAL201, safety and tolerability data are of paramount importance.
The headline safety and tolerability results demonstrated only one dose-limiting toxicity event occurred. This was at a maximum dose of 8 mg/kg, with the patient having raised blood pressure (severe hypertension). Following treatment for the raised blood pressure, the patient completed the remainder of the trial.
A Maximum Tolerated Dose has not been determined for VAL201, and all doses remain available for further testing.
No deaths were reported in patients during the clinical trial.
Further minor events listed as likely to be related to the administration of VAL201 are: Injection site disorders in 11 out of 12 patients; fatigue (5/12); dyspepsia (1/12); muscle spasm (1/12); hypertension (2/12); bradycardia (1/12).
During Q4 2020, the Company expects to receive the full Clinical Study Report and will use the complete data to publish the results on the National Institute of Health’s (NIH) public database ClinicalTrials.gov, as well as to produce research papers for peer-reviewed publications.
The Company intends to share these results with potential industry partners to evaluate all options for further clinical development of VAL201.
Dr Suzy Dilly, Chief Executive Officer commented: “I am delighted to be able to share these exciting results today, which are an accumulation of a lot of work by the wider team, both within and external to ValiRx. While considering these results it is important to remember that this is only the first clinical trial using VAL201, so this data has been generated using the utmost caution in sequentially dosing patients. Nevertheless, the headline results clearly demonstrate that VAL201 has the potential to be a safe and well-tolerated drug. With this data in hand, future studies will investigate optimal dosing strategies for VAL201 and help confirm these early indications of a positive response rate.”
Professor Alan Boyd, Consultant Pharmaceutical Physician and Medical Monitor for the study commented: “Development of effective treatments with low-side effects for patients with prostate cancer who have relapsed after radiotherapy is essential and will improve the lives of patients during treatment. I am pleased to have contributed to a project that has demonstrated such a good safety and tolerability profile while giving the first indications of a favourable effect on the patient’s disease.”
ValiRx accelerates the development of treatments in oncology and women’s health to improve patient lives. We provide the scientific, financial and commercial framework to enable rapid translation of innovative science into clinical development.
With our extensive and proven experience in research and drug development, we select and incubate promising novel drug candidates and guide them through an optimised process of development, from pre-clinical studies to clinic and investor-ready assets.
Integrating science and business
We connect diverse disciplines across scientific, technical and commercial domains, with the promise of achieving a more streamlined, less costly, drug development process. We work closely with our selected collaborators and leverage the combined expertise required for science to advance.
Lead candidates from our portfolio are out-licenced or partnered with investors through ValiRx subsidiary companies for further clinical development and commercialisation. https://www.valirx.com/
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