RE: Wow!28 Sep 2020 08:14
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