Language

English

Publication Date

1-1-2026

Journal

Integrative Cancer Therapies

DOI

10.1177/15347354251410182

PMID

41685666

PMCID

PMC12905094

PubMedCentral® Posted Date

2-13-2026

PubMedCentral® Full Text Version

Post-print

Abstract

Background: Withania somnifera (WS), commonly known as ashwagandha, has been used in the traditional medical system of India. It has shown significant activity against numerous solid tumor varieties in pre-clinical in vitro and in vivo studies. This study focuses on RH324 (ReHeva Biosciences, Columbus, OH), a pharmaceutical-grade formulation derived from WS, which has received FDA allowance for clinical development as a botanical drug in the treatment of cancer.

Methods: A phase 1 open label dose ranging study of oral RH324 in advanced non-small cell lung cancer (NSCLC) was conducted. The primary endpoint of the study was assessment of short-term safety and tolerability. An exploratory aim was assessment of RH324's anti-neoplastic effects as measured by changes in tumor metabolism using [18F]-labeled 2-fluoro-2-deoxy-D-glucose (FDG)-PET/CT scans performed before and after completing a 28-day RH324 monotherapy regimen. A total of 9 patients were enrolled, 5 of which completed the trial, including imaging, and were evaluable.

Results: All study safety and tolerability primary endpoints were met. Analysis revealed notable response rates across different SUV parameters (SUVmax, SUVmean, and SUVpeak) and there were no new metastatic lesions identified, further supporting RH324's anti-neoplastic effects.

Conclusion: RH324 was safe and well tolerated as a monotherapy in advanced NSCLC. FDG-PET/CT provided a novel methodology as a short-term metabolic endpoint with an in vivo biomarker assessment of potential clinical efficacy using a metabolic surrogate of disease activity. This approach offered deeper insights into tumor metabolism and heterogeneity, underscoring the potential of RH324's anti-neoplastic effects in treating refractory NSCLC.

Keywords

Humans, Plant Extracts, Lung Neoplasms, Male, Carcinoma, Non-Small-Cell Lung, Fluorodeoxyglucose F18, Withania, Plant Leaves, Female, Middle Aged, Positron Emission Tomography Computed Tomography, Aged, Adult, Biomarkers, Tumor, integrative oncology, phase 1 human trial, positron emission tomography, FDG, lung cancer, Withania somnifera

Comments

Clinical trial registration: ClinicalTrials.gov, Identifier: NCT05580172, Registered on October 17, 2022.

Trial registration: ClinicalTrials.gov NCT05580172 NCT00689195 NCT04092647.

Published Open-Access

yes

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