2012 Jun 2019 14:50
Well we have arrived now!
Here is the Dec 2017 RNS which made me invest:
ValiRx PLC re: VAL201 Clinical Trials
Source: UK Regulatory (RNS & others)
TIDMVAL
RNS Number : 5685Z
ValiRx PLC
18 December 2017
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 ot