Immunovaccine has reported positive interim results from the phase I trial evaluating the potency, safety and tolerability of DPX-Survivac alone or in combination with low-dose oral cyclophosphamide.
According to the interim results, all nine patients receiving DPX-Survivac in combination with cyclophosphamide produced a targeted immune response following only one or two vaccine administrations.
Immunovaccine chief science officer Marc Mansour said the interim results provide a support for the ongoing DPX-Survivac development programme as they demonstrate that the vaccine can activate the desired immunity in the target patient population.
"This offers further support of the fundamental advantages and potential of our DepoVax platform as a powerful vaccine adjuvanting technology," Mansour added.
Higher-doses (0.5mL) of DPX-Survivac in combination with cyclophosphamide (n=3) produced immune responses after only one vaccination, and exhibited higher antigen-specific immunity than the combination with a lower (0.1mL) DPX-Survivac dose (n=6), suggesting dose-related activity.
The patients in the two cohorts experienced steady immune responses that were detected at two consecutive time points.
The first three patients enrolled in the 0.5mL dose cohort in combination with low dose cyclophosphamide demonstrated an average stimulation factor of 350 times following the second vaccination, and in one patient greater than 850 times, over baseline responses, according to the study data.
The patients receiving DPX-Survivac without cyclophosphamide were capable of producing antigen-specific immune responses.
The vaccine was demonstrated to be safe and well tolerated while the adverse events were limited to expected local reactions at the site of vaccination.
The primary objective of the trial is to assess the safety of the vaccine with and without the presence of metronomic cyclophosphamide as an immune modulator while the secondary endpoint is the assessment of the immune response produced by the vaccine therapy.
Image: Immunovaccine has reported positive interim results from the phase I trial evaluating the potency, safety and tolerability of DPX-Survivac. Photo: Jmh649.