Brief: Polyphor Announces Second Positive Data Safety Monitoring

Spexis AG

03/08/2020 06:04

Aug 3 (Reuters) - POLYPHOR AG  POLN.S :
    * POLYPHOR ANNOUNCES SECOND POSITIVE DATA SAFETY MONITORING
BOARD
RECOMMENDATION TO CONTINUE PHASE III FORTRESS STUDY WITHOUT
MODIFICATIONS
    * STUDY WILL COMPRISE A TOTAL OF 384 PATIENTS WITH HER2
NEGATIVE
MBC, WITH AT LEAST 320 PATIENTS RECEIVING THIRD OR SUBSEQUENT
LINE AND 64 PATIENTS RECEIVING SECOND LINE CHEMOTHERAPY
    * SUBJECT TO DATA POLYPHOR MAY BE ABLE TO SUBMIT A FILING
FOR
ACCELERATED APPROVAL APPROXIMATELY SIX MONTHS AFTER RECRUITMENT
IS COMPLETED
    * FULL APPROVAL WOULD BE BASED ON MAGNITUDE OF PROGRESSION
FREE
SURVIVAL (PFS) ON BLINDED INDEPENDENT REVIEW, SUPPORTED BY AN
OVERALL SURVIVAL TREND FAVORING BALIXAFORTIDE ARM AND A
FAVORABLE RISK-BENEFIT PROFILE

Source text for Eikon:  ID:nEQbP7J6va 
Further company coverage:  POLN.S 

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