2021-10-11 18:30
publication
2021-10-11 18:30
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Mabion has received a permit to conduct a bridge clinical trial of MabionCD20 in patients with rheumatoid arthritis in Poland, the company said in a press release.
The permit was issued by the President of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products. The company also has the approval of the bioethics committee in this regard.
As stated, obtaining the permit enables the commencement of the clinical trial necessary to admit MabionCD20 in the first place in the EU, including the commencement of cooperation with clinical centers in Poland and the recruitment of patients for the study.
Mabion announced that the MabionCD20 clinical trial will be a three-arm bridging clinical trial in RA patients using MabionCD20 from the target production scale, MabThera being a European reference and Rituxan being an American reference.
“In accordance with the adopted protocol of the study, 280 patients from no less than 35 clinical centers located in Poland, Belgium, Georgia and Ukraine will ultimately participate in the bridge clinical trial. The company is currently waiting for consents to conduct a clinical trial in other countries mentioned outside Poland. The company does not exclude the possibility of extending the study to other countries “- it was written.
“The primary endpoint of the study will be the analysis of pharmacokinetic parameters for MabionCD20 derived from the target manufacturing scale and for MabThera and Rituxan. The adopted patient population will also allow for the evaluation of the effectiveness of the therapy, which is a secondary endpoint of the study” – added.
Basic follow-up of patients will last 6 months. Additionally, long-term monitoring of the safety and immunogenicity of the therapy will be carried out up to the 48th week from the first administration of the drug (PAP Biznes).
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