Background/Objective: With the increasing interest in natural products, a phase I openlabel
study of OMN54 (Aneustat™) in patients with advanced malignancies was initiated to determine
toxicity, maximum tolerated dose (MTD), dose limiting toxicities (DLT), and pharmacokinetics (PK).
OMN54 is a multitargeted agent, combining three Chinese botanicals; Ganoderma lucidium, Salvia
miltiorrhiza and Scutellaria barbata.
Methods: Eligible patients (pts) were >18 years of age with advanced solid tumors, able to swallow
oral capsules, ECOG performance status < 2, measurable disease as defined by RECIST 1.1 and adequate
Results: Twenty-two patients were enrolled in 6 dose levels, 2 with daily dosing and 4 with twicedaily
dosing ranging from 1 to 5 grams daily. All were evaluated for toxicity and 20 for response. No
treatment-related dose-limiting toxicities (DLTs) were reported and the recommended phase II dose
(RP2D) was determined to be 2.5 g twice daily. Seven adverse events in 5 patients were reported as
possibly drug-related; 6 were GI toxicity and 1 was a skin disorder. All were grade 1 except one grade
2 vomiting. No RECIST responses were seen. Six pts were treated with > 2 cycles; one for 8 cycles.
Four patients had reductions in TGF –β and EGF, exploratory biomarkers possibly suggestive of a
drug effect. Plasma half-lives of 1 -2 hours were noted for all parent drug chemical markers with no
accumulation over time.
Conclusion: OMN54 was well tolerated, with no DLTs observed. Further studies at the RP2D will assess
the biological activity.