December 23, 2016 / 9:25 AM / a year ago

BRIEF-DSMB positively assesses Mabion's comparative study of MabionCD20 drug

Dec 23 (Reuters) - Mabion SA :

* Said on Thursday that Data and Safety Monitoring Board (DSMB) assessed clinical data and safety data obtained from patients in comparative study of the drug MabionCD20 and the MabThera reference product (MabThera)

* After the evaluation reports on the general course of the clinical trial and other presented data on safety and efficacy DSMB positively assessed the conduct of the company’s study and recommended its further running without having to make changes in the protocol

* Company said adverse drug reactions observed in a clinical study in any of the two groups of patients did not differ significantly neither in the scope nor the severity from the typical side effects of treatment with MabThera

* Said this may suggest that regulatory risk in terms of the safety profile of MabionCD20 compared to MabThera decreased

* DSMB examined data obtained from 561 patients on March 28 and raw data obtained from additional 148 patients between March 28 and Dec. 21

* As of Dec. 21, all 709 patients received all the drug doses under the research protocol and the drop out under the research is 11.16 pct, lower than expected

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