US-based ProtoKinetix has reached the midpoint of a Phase-one first-in-human clinical trial of AAGP PKX-001 treated islet cells used in conjunction with the Edmonton Protocol for the treatment of Type-one diabetes, it was reported yesterday.
Six patients were recruited and treated under this protocol, and all primary safety objectives were achieved at the midpoint in all participants. PKX-001 is the designation given to the lead drug product molecule of the AAGP family.
The company will now increase the number of participants in the trial with additional secondary objectives added, including dose escalation to establish optimisation criteria for efficacy testing.
The trial is being led by Dr James Shapiro.
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