The ALN-VSP Phase I trial is designed to recruit patients with advanced solid tumors with liver involvement who have failed to respond to or have progressed after standard treatment.
The primary objective of the trial is to evaluate safety and tolerability of up to eight potential dose levels ranging from 0.1 to 1.7mg/kg.
In the trial, ALN-VSP was administered to over 40 patients at doses ranging from 0.1 to 1.5mg/kg, with multiple patients continuing to receive therapy.
Alnylam Clinical Research senior director Jared Gollob said the data from this program have been encouraging to date, and the results are important not only for the continued advancement of ALN-VSP toward Phase II studies but also for the overall advancement of systemically delivered RNAi therapeutics.