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DMC approves colorectal cancer cohort expansion
DMC approves colorectal cancer cohort expansion.
About this update from Faron Pharmaceuticals Oy
[{"type":"text","content":"\n \nRNS Number : 5158Z Faron Pharmaceuticals Oy 13 January 2020 \n\nFaron Pharmaceuticals Oy\n(\"Faron\" or the \"Company\")\n \nMATINS TRIAL UPDATE \nData monitoring committee approves initiation of expansion cohort in colorectal cancer patients\n \n \nCompany announcement, 13 January 2020 at 9.00 AM (EET)Inside information\n \nTURKU - FINLAND - Faron Pharmaceuticals Oy (AIM: FARN, First North: FARON), the clinical stage biopharmaceutical company, today announces approval from the MATINS trial's data monitoring committee (\"DMC\") to initiate the study's first expansion cohort, Part II, in patients suffering from late-stage colorectal cancer (CRC), following a successful conclusion of the dose escalation in Part I. \n \nThe phase I/II MATINS clinical trial is investigating the tolerability, safety and efficacy of Clevegen, Faron's wholly-owned novel precision cancer immunotherapy targeting Clever-1 positive tumour associated macrophages (TAM), in selected metastatic or inoperable solid tumours. \n \nThe DMC has accepted the Company's proposal that the initial Clevegen dose for Part II of the study should be 0.3 mg/kg. This follows analysis of the data from patients in Part I of the study who received doses of 0.1 mg/kg, 0.3 mg/kg, 1.0 mg/kg, 3.0 mg/kg and 10 mg/kg. All dose levels tested showed good tolerability with no dose limiting toxicity signals. While the dose of 0.3 mg/kg has been associated with a clinical response and has produced the strongest immune response (Natural killer cell activation, CD8+ T-cell increase), the efficacy of another Part I dose level cohort (1.0 or 3.0 mg/kg) may be tested separately during Part II following completion and final analysis of Part I. \n \nA total of 10 late-stage CRC patients are expected to be dosed in this 0.3 mg/kg cohort, including two patients who had previously received this dose in the earlier Part I of the study. Commencement of other distinct cancer cohorts will follow the CRC cohort.\n \nDr. Markku Jalkanen, Faron's CEO, said: \"We continue to be impressed by the potential of Clevegen and are very pleased to have the DMC's support for the commencement of Part II of the MATINS trial. At just 0.3 mg/kg the dose could provide an unusually high safety margin for the use of this potential therapy as a stand-alone treatment o...