Information received from the study centre confirms its course in accordance with the schedule and assumptions in terms of patient safety as defined in the clinical protocol approved by the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products. In the first part of the phase 1 trial were administered a drug dose provided for in the clinical protocol. An analysis of safety results and pharmacokinetic features will be used to select a drug administration regimen for the second part of the phase 1 trial.
Maciej Wieczorek, PhD, President of the Board of Celon Pharma S.A.: e will now be analysing data in order to establish the final drug administration regimen for the second part of the phase 1 trial. The current course of the trial and patient follow-up fully reflect the assumptions adopted by us in the clinical trial protocol both in terms of the participants' safety and the schedule of the clinical programme.
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