nucleonics hep b ddrnai drug human phase 1b

Came across this recent abstract of a study (which will be copied at the end of this post). Phase 1b in humans, no less! I thought, hmmm, NUC B1000, let's google it, and lo and behold, it is Nucleonics drug which is a ddRNAi construct! This drug was the whole big patent battle that destroyed Nucleonics and crippled Benitec all those years ago! I wonder who is sponsoring the study now that Nucleonics is defunct.

Exciting that this is actually Phase 1 in humans.

Anyway, more people doing Benitec's work for free.

Antivir Ther. 2011;16(4):547-54.
RNA interference and its potential applications to chronic HBV treatment: results of a Phase I safety and tolerability study.
Gish RG, Satishchandran C, Young M, Pachuk C.
Source

Center for Hepatobiliary Disease and Abdominal Transplantation, UCSD Medical Center, San Diego, CA, USA. [email protected].
Abstract
BACKGROUND:

RNA interference (RNAi) provides an attractive tool to modulate biological systems, and ultimately, to treat human diseases. We describe early results from a Phase Ib, first-in-human safety and tolerability study of an RNAi-based therapy, NUC B1000, among patients with mild to moderate chronic HBV.
METHODS:

Three subjects received a single 5 mg DNA dose of NUC B1000 as part of a planned dose escalation study.
RESULTS:

All participants reported pharyngitis, chills, myalgia and fever approximately 4-7 h after dosing. All subjects were asymptomatic after a single antipyretic dose with no symptom recurrences. Measurements of interferon (IFN)-α and -γ, interleukin (IL)-10, 12 18, 8 and 6, and tumour necrosis factor-α performed before and after dosing revealed cytokine increases before study drug administration. After drug administration, IFN-γ and IL-10 increased in two patients; IL-8 increased in one. Most increases returned to pretreatment levels within 1 week. Two patients were subsequently successfully treated with entecavir indicating that NUC B1000 does not compromise subsequent antiviral therapy.
CONCLUSIONS:

Thus far, NUC B1000 appears safe and well-tolerated; safety and efficacy studies across a larger, more diverse patient spectrum using increasing doses are needed to determine its appropriate role in the antiviral armamentarium.

PMID:
21685542
[PubMed - in process]