Brief: Cytodyn Finalizes Development Of Receptor Occupancy Test To Guide Pivotal Monotherapy Discussions With The FDA

Cytodyn

25/07/2019 11:44

July 25 (Reuters) - Cytodyn Inc  CYDY.PK :
    * CYTODYN FINALIZES DEVELOPMENT OF RECEPTOR OCCUPANCY
TEST TO
GUIDE PIVOTAL MONOTHERAPY DISCUSSIONS WITH THE FDA
    * CYTODYN - COMPLETION OF DEVELOPMENT OF RECEPTOR OCCUPANCY
TEST
TO MEASURE EXPRESSION OF CCR5 IN HIV AND TUMOR CELLS THAT ARE
OCCUPIED BY LERONLIMAB
    * CYTODYN INC - THERE HAVE BEEN NO DRUG RELATED SERIOUS
ADVERSE
EVENTS ("SAES") REPORTED IN ANY OF HIV PATIENTS TREATED WITH
LERONLIMAB
    * CYTODYN INC - RESPONSE RATE FOR FIRST 10 WEEKS OF
LERONLIMAB
MONOTHERAPY IN HIV PATIENTS HAS APPROXIMATED 95% WITH 525 MG
DOSAGE
    * CYTODYN INC - GRANTED AN IN-PERSON MEETING WITH U.S. FDA
TO
DISCUSS ITS PIVOTAL MONOTHERAPY PROTOCOL THAT COULD LEAD TO
LABEL EXPANSION APPROVAL
    * CYTODYN INC - TO DATE, 110 PATIENTS HAVE REACHED
APPROXIMATELY
ONE YEAR OF MONOTHERAPY TRIAL WITH SIX PATIENTS IN EXTENDED
PORTION REACHING ALMOST THREE YEARS

Source text for Eikon:  ID:nGNX4Ck9G6 
Further company coverage:  CYDY.PK 

 ((Reuters.Briefs@thomsonreuters.com;))