VAL201 / ValiRx - LARVOL DELTA

ValiRx announced a new wholly owned subsidiary Blue Ribbon Bio on Tuesday, to consolidate its prostate cancer assets and accelerate development of its Val201 peptide therapy. (London South East) - "The AIM-traded life sciences company said Blue Ribbon would initially hold intellectual property for Val201, licensed from Cancer Research Horizons in 2010, with plans to file new application-based patents as development work progresses."

Commercial • Prostate Cancer

VAL201 Clinical Trial Full Data Results (PharmiWeb) - P1/2, N=12; NCT02280317; Sponsor: ValiRx Plc; "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...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."

P1/2 data • Genito-urinary Cancer • Oncology • Prostate Cancer

VAL201 Clinical Trial Update (PharmiWeb) - P1/2, N=12; NCT02280317; Sponsor: ValiRx Plc; "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...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)."

P1/2 data • Genito-urinary Cancer • Oncology • Prostate Cancer

Dose Finding Safety Study of VAL201 in Cancer Patients (clinicaltrials.gov) - P1/2; N=12; Completed; Sponsor: ValiRx Plc; N=18 ➔ 12

Clinical • Enrollment change • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

ValiRx shares jump in early trading after patent filing (Proactiveinvestors) - Based on results in endometrial models, VAL201 has been shown to reduce the abnormal endometrial growth, while leaving other hormone-induced activities working normally

Patent update

Dose Finding Safety Study of VAL201 in Cancer Patients (clinicaltrials.gov) - P1/2; N=50; Enrolling by invitation; Sponsor: ValiRx Plc; Trial completion date: Dec 2018 ➔ Jun 2019; Trial primary completion date: Dec 2018 ➔ Jun 2019

Trial completion date • Trial primary completion date • Biosimilar • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor • Urothelial Cancer

Dose Finding Safety Study of VAL201 in Cancer Patients (clinicaltrials.gov) - P1/2; N=50; Enrolling by invitation; Sponsor: ValiRx Plc; N=25 -> 50

Enrollment change • Biosimilar • Oncology • Prostate Cancer

Dose Finding Safety Study of VAL201 in Cancer Patients (clinicaltrials.gov) - P1/2; N=18; Completed; Sponsor: ValiRx Plc; Enrolling by invitation ➔ Completed; N=50 ➔ 18

Clinical • Enrollment change • Trial completion

ValiRx announces that in addition to pharmacokinetic and toxicology data, clinical trial results show VAL201 behaves as predicted in reducing prostate cancer progression (PharmiWeb) - "ValiRx...announces that its lead therapeutic compound, VAL201, has thus far and continues to meet all the published endpoints in its first-in-human study...Beyond the fundamental safety and tolerability endpoints for the trial, the study has provided clear pharmacokinetic information about the uptake, distribution, metabolism and elimination of the compound in humans. The data supports and confirms the findings from preclinical and the earliest stages of human studies and in part explains the reduction in prostate cancer progression as measured by PSA - evidence that is supported from tumour imaging (MRI and CT) in subjects."

PK/PD data

Dose Finding Safety Study of VAL201 in Cancer Patients (clinicaltrials.gov) - P1/2; N=50; Enrolling by invitation; Sponsor: ValiRx Plc; Trial completion date: Jun 2019 ➔ Dec 2019; Trial primary completion date: Jun 2019 ➔ Dec 2019

Clinical • Trial completion date • Trial primary completion date

Istria County CPR Survival 2011-2017 (clinicaltrials.gov) - P=N/A; N=1440; Completed; Sponsor: University Hospital Dubrava; Recruiting ➔ Completed

Trial completion

"ValiRx $VAL Update on VAL201 & VAL301 Development Progress https://t.co/jVAgiUAu8n Scancell Hlds $SCLP Professor Lindy Durrant receives Waldenström award https://t.co/r62jZYo9Hj Mereo BioPharma $MPH Publication of Form F-4 https://t.co/Tad3dqsTnh" (@BiotechRadar)