Clinical Trial Publications
A phase I/II MATINS trial: Part 1 pharmacokinetic, safety and efficacy results of Clever-1 blockade in advanced cancer
01/09/2020
CLEVER-1 is a scavenger receptor expressed in tumour associated macrophages. We worked with Faron Pharmaceuticals on this trial, designed to assess the safety and preliminary efficacy of FP-1305 in patients with advanced solid tumours. It showed that the compound promotes immune switch and peripheral lymphocyte activation and has promising tolerability.
Immune activation in first-in-human anti-macrophage antibody (anti-Clever-1 mAb; FP-1305) phase I/II MATINS trial: Part I dose-escalation, safety, and efficacy results.
20/05/2020
We worked with Faron Pharmaceuticals on this trial, a multicentre first-in-human phase I/II study. It assessed the tolerability, safety and preliminary efficacy of FP-1305 in patients with advanced cancers including immunotherapy-refractory melanoma, cholangiocarcinoma, hepatocellular carcinoma, ovarian cancer, colorectal (CRC), and pancreatic ductal adenocarcinoma.
Impact of the Selective Orexin‐1 Receptor Antagonist ACT‐539313 on the Pharmacokinetics of the CYP3A Probe Drug Midazolam in Healthy Male Subjects
09/02/2020
Simbec-Orion worked with X on this single‐center, open‐label, fixed‐sequence study. It examined the effect of ACT‐539313 on the pharmacokinetics of orally administered midazolam to investigate the interaction potential.
Immune activation with a novel immune switch anti-macrophage antibody (anti-Clever-1 mAb; FP-1305) in phase I/II first-in-human MATINS trial in patients with advanced solid tumours
01/10/2019
Simbec-Orion worked with Faron Pharmaceuticals Ltd. in this phase I/II first-in-human in patients with advanced solid tumours, studying the effect of FP-1305. Analysis of circulating immune cells after administration of the compound demonstrates Th1 activation as well as mobilization of NK cells and B cells. It showed promising tolerability and clinical anti-tumour activity.
Comparative Bioavailability Study of a New Orodispersible Formulation of Ibuprofen Versus Two Existing Oral Tablet Formulations in Healthy Male and Female Volunteers
12/06/2019
Simbec-Orion worked with Reckitt Benckiser Health Limited on this study. It analysed the comparative bioavailability between ibuprofen acid orodispersible tablets and ibuprofen acid oral tablets.
Bioequivalence of 2 Naproxen Sodium Tablet Formulations in Healthy Male and Female Volunteers
18/01/2019
Simbec-Orion worked with Reckitt Benckiser Health Limited. This study looked at Reckitt Beckiser Healths’ naproxen sodium tablet’s comparative bioavailability against a reference medicinal product, Aleve naproxen sodium (220 mg).
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