Fusion Pharma marks in-house radiopharma manufacturing success, details PhII/III trial study

Fu­sion Phar­ma­ceu­ti­cals said it has man­u­fac­tured the first clin­i­cal dose of its ra­dio­phar­ma­ceu­ti­cal as­set in-house and has agreed with the FDA on the de­sign of a Phase II/III study in metasta­t­ic cas­tra­tion-re­sis­tant prostate can­cer.

The Cana­di­an com­pa­ny has se­cured good man­u­fac­tur­ing prac­tice (GMP) val­i­da­tion for its man­u­fac­tur­ing fa­cil­i­ty in Hamil­ton, On­tario, lead­ing to the pro­duc­tion of its tar­get­ed al­pha ther­a­py, a Thurs­day re­lease states. Tar­get­ed al­pha ther­a­py, or TAT, is an ap­proach where­by the ra­dio­ther­a­py goes through al­pha de­cay, which can be cy­to­tox­ic to near­by cells.

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