Celon Pharma S.A. has finalised the preclinical phase and has submitted an application to the President of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products for the consent to commence the next stage of the trial, i.e. the clinical phase.
Phase I of the CLP304110 trial is a multicentre trial carried out on patients with advanced-stage solid tumours. The trial will be made up of 3 parts. The first part consists in administration of the drug in increasing doses to all patients meeting the inclusion criteria with numerous different solid tumours. The second part consists in administration of the drug in increasing doses to patients with advanced lung, bladder and stomach tumours in whom tumours have FGFR kinase genetic aberrations. This part is expected to determine the maximum tolerated dose of the drug (the so-called MTD dose). Part 3 of the study consists is the escalation of MTD on a group of up to 12 patients to confirm the safety profile and to demonstrate early signals of drug activity. The entire study trial will involve 30 to 40 patients. The estimated duration of the trial is several months. The time of examination depends on the speed at which patients are enrolled, especially patients with specific genetic aberration. With the clinical development CPL30410, the Company develops modern, own diagnostic tests.
Phase I clinical trial for an innovative FGFR kinase inhibitor is implemented under the Celonko project with regard to clinical development, in cooperation with key cancer institutes in Poland. The Company’s project obtained PLN 38 million of co-funding for the project under the Innovative Economy Operational Programme.