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Clevegen successful toxicity studies
Clevegen successful toxicity studies.
About this update from Faron Pharmaceuticals Oy
[{"type":"text","content":"\n \nRNS Number : 8306S Faron Pharmaceuticals Oy 28 June 2018 \n\nFaron Pharmaceuticals Ltd\n(\"Faron\" or the \"Company\")\n \nClevegen shows good safety and potential to block Clever-1 on circulating monocytes\n \n· Wholly-owned Clevegen (FP-1305) shows no toxicity in dose escalation studies in large preclinical models\n· The no-observed-adverse-effect-level (NOAEL) was 100 mg/kg, which is roughly 30 times higher concentration than needed for Clever-1 occupancy in vivo\n· Clevegen also blocked Clever-1 on circulating monocytes as expected. The duration of blocking was dose dependent and resumed to normal level in 20 days in the highest dose\n· The Company expects CTA filing for MATINS study in Q3 2018 and first patient recruitment in Q4 2018\n \nTURKU - FINLAND, 28 June 2018 - Faron Pharmaceuticals Ltd (\"Faron\") (AIM: FARN), the clinical stage biopharmaceutical company, today announces successful toxicity studies and control of blood Clever-1 positive monocytes, precursor cells to tumour associated macrophages (TAM) in large preclinical models.\n \nThe toxicity studies were designed to fulfil regulatory requirements for 3-week interval intravenous administration of Clevegen, typical for other anti-cancer antibodies currently in use. FP-1305 is a humanized IgG4 monoclonal antibody produced in CHO -cells by Faron collaborator Abzena. The FP-1305 drug product in its final formulation was administered as a single dose at 3, 30 and 100 mg/kg.\n \nNo toxicologically relevant changes were observed in any subject. No major changes were observed after treatment with FP-1305 in T lymphocytes subsets. The binding of Clevegen to its receptor on circulating CD14+ monocytes was confirmed by investigating the receptor occupancy, the recovery of which occurred between 3 to 20 days after dosing in a dose-dependent manner. No relevant changes were present in cytokines and no anti-drug antibodies (ADA) were detected in any subject. Therefore, the highest dose of 100 mg/kg was considered the no-observed-adverse-effect-level (NOAEL).\n \nDr Markku Jalkanen, CEO of Faron, said: \"We are very encouraged to find out about the good safety profile of our wholly-owned asset Clevegen and the high NO...