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Chk1 Clinical Trials Update
Chk1 Clinical Trials Update.
About this update from Sareum Holdings Plc
[{"type":"text","content":"\n \nRNS Number : 1628H Sareum Holdings PLC 05 June 2017 \n\n\n\n\n\n (AIM: SAR)\n\n\n5 June 2017\n\n\n\n\nSAREUM HOLDINGS PLC\n(\"Sareum\" or \"the Company\")\nChk1 Clinical Trials Update\nSierra Oncology Reports Encouraging Initial Progress from Ongoing Phase 1 Clinical Trials\nSareum Holdings plc (AIM:SAR), the specialist cancer drug discovery and development company, notes an announcement made today by Sierra Oncology, Inc. reporting on the initial progress of the two ongoing Phase 1 trials of the Chk1 inhibitor, SRA737. The full announcement can be found on Sierra Oncology's IR website*.\nThis announcement contains inside information for the purposes of Article 7 of Regulation 596/2014.\nThe SRA737 Phase 1 monotherapy trial has advanced through six single patient dose cohorts of 20, 40, 80, 160, 300 and 600 mg/day, administered under a continuous daily oral dosing regimen in 28-day cycles. Dose escalation will continue until a maximum tolerated dose (MTD) is reached, in parallel with ongoing Cohort Expansion enrolment. \nPreliminary observations from the ongoing monotherapy study are as follows: \n• SRA737 has been very well-tolerated to date: No Grade 2 or higher SRA737-related adverse events have been reported. No dose-limiting toxicities have been observed and an MTD has not been reached. \n• Dose-proportional exposure: Pharmacokinetic (PK) parameters for SRA737 have been generally linear across the dose range tested to date. \n• Plasma concentrations of SRA737 exceeding the proposed minimum efficacious threshold (Cmin) of 100 nM were maintained for 24 hours post-dose at the 160 mg/day dose level and above. \nHaving successfully surpassed the proposed minimum efficacious exposure threshold, the Cohort Expansion Phase of the trial has commenced and is enrolling patients with tumours identified to have genetic aberrations hypothesized to confer sensitivity to Chk1 inhibition via synthetic lethality into five indication-specific cohorts: colorectal, head and neck, non-small cell lung, ovarian, and prostate cancers. \nFor the Phase 1 Chemotherapy Combination study, Stage 1, which is evaluating SRA737 in combination with gemcitabine and cisplatin, has concluded enrolment and the study has transitioned to Stage 2. This stage is seeking to establish the safety profile, determine the...