ProNAi Therapeutics (ProNAi), a licensee of the Smarticles technology, has dosed first patient in a Phase I clinical study of PNT2258 in patients with advanced solid tumors.
PNT2258 is an oligonucleotide therapeutic encapsulated within Marina Biotech’s proprietary Smarticles delivery technology.
The Smarticles delivery technologywas developed by Novosom and acquired by Marina Biotech in July 2010.
The Phase 1 clinical trial is a single-center, open labeled dose escalation study of PNT2258 administered intravenously in cancer patient volunteers with a primary objective to assess the safety and tolerability of PNT2258.
The study is also expected to examine the pharmacokinetics of PNT2258 and explore biomarkers with the goal of identifying doses for subsequent efficacy studies in cancer patients.
Marina Biotech president and CEO Michael French said that the first dosing of this new nucleic acid-based therapeutic is the culmination of tremendous effort on the part of both ProNAi and Novosom over the last several years.
“We are pleased to see a Smarticles formulation advance into human clinical testing and we hope to see significant advancement of our amphoteric liposomal delivery technology over the coming months with this first-in-human experience with ProNAi coupled with the further development of this technology in our RNAi-based drug discovery platforms,” French said.