TY - JOUR
T1 - Mechanism-Driven and Clinically Focused Development of Botanical Foods as Multitarget Anticancer Medicine
T2 - Collective Perspectives and Insights from Preclinical Studies, IND Applications and Early-Phase Clinical Trials
AU - Wang, Xiaoqiang
AU - Chan, Yin S.
AU - Wong, Kelly
AU - Yoshitake, Ryohei
AU - Sadava, David
AU - Synold, Timothy W.
AU - Frankel, Paul
AU - Twardowski, Przemyslaw W.
AU - Lau, Clayton
AU - Chen, Shiuan
N1 - Publisher Copyright:
© 2023 by the authors.
PY - 2023/2
Y1 - 2023/2
N2 - Cancer progression and mortality remain challenging because of current obstacles and limitations in cancer treatment. Continuous efforts are being made to explore complementary and alternative approaches to alleviate the suffering of cancer patients. Epidemiological and nutritional studies have indicated that consuming botanical foods is linked to a lower risk of cancer incidence and/or improved cancer prognosis after diagnosis. From these observations, a variety of preclinical and clinical studies have been carried out to evaluate the potential of botanical food products as anticancer medicines. Unfortunately, many investigations have been poorly designed, and encouraging preclinical results have not been translated into clinical success. Botanical products contain a wide variety of chemicals, making them more difficult to study than traditional drugs. In this review, with the consideration of the regulatory framework of the USFDA, we share our collective experiences and lessons learned from 20 years of defining anticancer foods, focusing on the critical aspects of preclinical studies that are required for an IND application, as well as the checkpoints needed for early-phase clinical trials. We recommend a developmental pipeline that is based on mechanisms and clinical considerations.
AB - Cancer progression and mortality remain challenging because of current obstacles and limitations in cancer treatment. Continuous efforts are being made to explore complementary and alternative approaches to alleviate the suffering of cancer patients. Epidemiological and nutritional studies have indicated that consuming botanical foods is linked to a lower risk of cancer incidence and/or improved cancer prognosis after diagnosis. From these observations, a variety of preclinical and clinical studies have been carried out to evaluate the potential of botanical food products as anticancer medicines. Unfortunately, many investigations have been poorly designed, and encouraging preclinical results have not been translated into clinical success. Botanical products contain a wide variety of chemicals, making them more difficult to study than traditional drugs. In this review, with the consideration of the regulatory framework of the USFDA, we share our collective experiences and lessons learned from 20 years of defining anticancer foods, focusing on the critical aspects of preclinical studies that are required for an IND application, as well as the checkpoints needed for early-phase clinical trials. We recommend a developmental pipeline that is based on mechanisms and clinical considerations.
KW - botanical drugs
KW - botanical food products
KW - cancer target therapy
KW - early-phase clinical trials
KW - investigational new drug
KW - preclinical study
UR - http://www.scopus.com/inward/record.url?scp=85147832447&partnerID=8YFLogxK
U2 - 10.3390/cancers15030701
DO - 10.3390/cancers15030701
M3 - Review article
C2 - 36765659
AN - SCOPUS:85147832447
SN - 2072-6694
VL - 15
JO - Cancers
JF - Cancers
IS - 3
M1 - 701
ER -