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BRIEF-MEDICENNA UPDATES ON-GOING PHASE 2B CLINICAL TRIAL PROTOCOL FOR RECURRENT GLIOBLASTOMA
2017年9月28日 / 晚上9点45分 / 22 天内

BRIEF-MEDICENNA UPDATES ON-GOING PHASE 2B CLINICAL TRIAL PROTOCOL FOR RECURRENT GLIOBLASTOMA

Sept 28 (Reuters) - Medicenna Therapeutics Corp:

* MEDICENNA UPDATES ON-GOING PHASE 2B CLINICAL TRIAL PROTOCOL FOR RECURRENT GLIOBLASTOMA

* ‍AMENDED PROTOCOL INCORPORATES AN ENHANCED DRUG DELIVERY PROCEDURE WHICH WILL BE USED FOR TREATMENT OF REMAINING PATIENTS ​

* COMMENCED IMPLEMENTATION OF UPDATED PROTOCOL FOLLOWING ITS SUBMISSION TO FDA & APPROVAL BY RESPECTIVE INSTITUTIONAL REVIEW BOARDS​

* ‍UPDATED PROTOCOL INCLUDES HIGHER DOSES AND VOLUMES OF MDNA55​

* ‍EARLY RESULTS FROM INTERIM SAFETY ANALYSIS INDICATES CURRENT DOSE OF MDNA55 BEEN WELL TOLERATED IN INITIAL COHORT OF PATIENTS​

* PROTOCOL AMENDMENT BASED ON PLANNED SAFETY ANALYSIS FOLLOWING UNANIMOUS RECOMMENDATION FROM MDNA55‘S SAFETY REVIEW COMMITTEE​

* SEES ENROLLMENT TO BE COMPLETED BY EARLY 2018, WITH INTERIM TOP-LINE RESULTS EXPECTED DURING FIRST HALF OF 2018 FOR MDNA55​

* UPDATED PROTOCOL INCLUDES INCREASE IN TOTAL EXPECTED STUDY SIZE FROM 43 PATIENTS TO 52 TOTAL PLANNED PATIENTS

* IN AMENDMENT OF PROTOCOL, PRIMARY ENDPOINT OF STUDY REMAINS SAME​

* ‍BASED ON EXCEPTIONAL SAFETY PROFILE, CONCENTRATION OF MDNA55 WILL BE DOUBLED TO 3.0 MG/ML

* ‍BASED ON EXCEPTIONAL SAFETY PROFILE, VOLUME ADMINISTERED WILL BE MAXIMIZED TO A FIXED VOLUME OF 60ML​ Source text for Eikon: Further company coverage:

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