astragalus polysaccharides (PG2) / PhytoHealth Corp - LARVOL DELTA

Clinical Efficacy and Outcomes of Astragalus Polysaccharides (PG2) toward Cancer-related Fatigue of Advanced Breast Cancer Patients (SABCS 2024) - "The retrospective study demonstrated that PG2 exhibits significant therapeutic efficacy in relieving CRF among advanced breast cancer patients. Premenopausal and non-VM patients might be more beneficial to PG2 treatment."

Clinical • Metastases • Breast Cancer • Oncology • Solid Tumor

Immunomodulatory effects and improved survival of PG2 plus preoperative chemoradiotherapy in patients with locally advanced esophageal cancer (ESMO 2024) - P2 | "PG2 combined with preoperative CCRT in advanced esophageal cancer has shown promising improvements in OS and modulation of the immune microenvironment."

Clinical • Immunomodulating • Metastases • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Gastrointestinal Cancer • Oncology • Squamous Cell Carcinoma • IL10 • IL12A • IL1B • IL4 • IL6

PhytoHealth Corporation announced a new clinical study results published at 2024 ESMO Congress: PG2 plus preoperative chemoradiotherapy improves survival in patients with locally advanced esophageal cancer (PRNewswire) - P2 | N=48 | NCT03611712 | Sponsor: PhytoHealth Corporation | "A groundbreaking study conducted by PhytoHealth Corporation...has revealed that combining Astragalus Polysaccharides (PG2Lyo. Injection) with standard concurrent chemoradiotherapy (CCRT) significantly improves survival rates for patients with advanced esophageal cancer....Results showed that patients who received PG2 in addition to CCRT experienced significantly longer overall survival compared to those who received CCRT alone. Furthermore, the combination therapy resulted in a higher tumor objective response rate. The study also found that PG2 helped strengthen the immune system by modulating the tumor immune microenvironment (TIME) and enhancing the suppression of tumor growth."

P2 data • Esophageal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

Complementary Treatment of PG2 to Improve Clinical Benefit Response and Quality of Life in Fatigue (clinicaltrials.gov) - P2/3 | N=13 | Terminated | Sponsor: PhytoHealth Corporation | N=210 ➔ 13

Enrollment change • Fatigue • Neutropenia

PG2 Concurrent With Chemoradiation for Locally Advanced Esophageal Cancer (clinicaltrials.gov) - P2 | N=48 | Active, not recruiting | Sponsor: PhytoHealth Corporation | Recruiting ➔ Active, not recruiting | Trial completion date: Dec 2025 ➔ Feb 2025 | Trial primary completion date: May 2023 ➔ Feb 2023

Enrollment closed • Trial completion date • Trial primary completion date • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Fatigue • Gastric Cancer • Gastrointestinal Cancer • Oncology

Effect of astragalus polysaccharides (PG2) treatment of adjuvant chemotherapy-induced fatigue in premenopausal patients with breast cancer. (ASCO 2023) - P2 | "The aim of this study is to evaluate the efficacy of PG2 as a complementary treatment among stage II/III BC patients with adjuvant chemotherapy of epirubicin-cyclophosphamide(EC) regimen in reduction of chemotherapy-induced toxicity and encouraging compliance with chemotherapy. PG2 combined with adjuvant EC significantly improved adjuvant EC-induced fatigue in premenopausal BC patients. PG2 assists these patients with maintaining normal daily life and job activities, also less need of family support during chemotherapy. Furthermore, patients treated with PG2 might have better compliance to complete the whole course of adjuvant chemotherapy."

Clinical • Breast Cancer • Fatigue • Hematological Disorders • Neutropenia • Oncology • Solid Tumor

PG2 Injection for the Treatment of moderate-to Severe Fatigue in Breast Cancer Patients (clinicaltrials.gov) - P2 | N=36 | Recruiting | Sponsor: PhytoHealth Corporation

New P2 trial • Breast Cancer • Fatigue • Oncology • Solid Tumor

PG2 Treatment Among Stage II/III Breast Cancer Patients Receiving Adjuvant Chemotherapy (clinicaltrials.gov) - P2 | N=67 | Completed | Sponsor: PhytoHealth Corporation | Recruiting ➔ Completed

Trial completion • Breast Cancer • Fatigue • Hematological Disorders • Neutropenia • Oncology • Solid Tumor • CSF3

PG2 Concurrent With Chemoradiation for Locally Advanced Esophageal Cancer (clinicaltrials.gov) - P2 | N=40 | Recruiting | Sponsor: PhytoHealth Corporation | Trial completion date: Dec 2021 ➔ Dec 2025 | Trial primary completion date: Oct 2021 ➔ May 2023

Trial completion date • Trial primary completion date • Cervical Cancer • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Fatigue • Gastric Cancer • Gastrointestinal Cancer • Immune Modulation • Oncology

PG2 injection, a novel botanical drug approved for improving cancer-related fatigue among advanced cancer patients under standard palliative care: A double blind, multi-center, randomized phase IV study. (ASCO 2018) - P4; "This study demonstrates that more than 60% of subjects showed at least 10% improvement in fatigue score when compared to baseline after both 250mg and500mg PG2 treatments."

Clinical • P4 data • Oncology

PG2 Treatment Among Stage II/III Breast Cancer Patients Receiving Adjuvant Chemotherapy (clinicaltrials.gov) - P2; N=75; Recruiting; Sponsor: PhytoHealth Corporation; Trial completion date: Jun 2021 ➔ Oct 2021; Trial primary completion date: Dec 2020 ➔ Jun 2021

Clinical • Trial completion date • Trial primary completion date • Breast Cancer • Fatigue • Hematological Disorders • Neutropenia • Oncology • Solid Tumor • CSF3

Study of PG2 Injection for Improving Fatigue in Patients After Palliative Abdominal Surgery for Cancer (clinicaltrials.gov) - P2; N=0; Withdrawn; Sponsor: PhytoHealth Corporation; N=50 ➔ 0

Enrollment change • Fatigue • Oncology • IL10 • IL1B • IL4 • IL6 • TNFA

A Phase II Trial of PG2 in Patients With Advanced Pharyngeal or Laryngeal Squamous Cell Carcinoma Under Concurrent Chemoradiotherapy (clinicaltrials.gov) - P2; N=60; Recruiting; Sponsor: PhytoHealth Corporation; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • P2 data • Fatigue • Oncology • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • CRP

PG2 Treatment for Improving Fatigue Among Advanced Cancer Patients Under Standard Palliative Care (clinicaltrials.gov) - P4; N=250; Recruiting; Sponsor: PhytoHealth Corporation

Clinical • New P4 trial • Fatigue • Oncology • Palliative care • CRP

The Pilot Clinical Study of PG2 Injection on Hemorrhagic Stroke (clinicaltrials.gov) - P0; N=60; Completed; Sponsor: PhytoHealth Corporation; Recruiting ➔ Completed

Clinical • Trial completion • Cardiovascular • Cerebral Hemorrhage • Hematological Disorders • CRP • IL6

A Phase II Trial of PG2 in Patients With Advanced Pharyngeal or Laryngeal Squamous Cell Carcinoma Under Concurrent Chemoradiotherapy (clinicaltrials.gov) - P2; N=60; Recruiting; Sponsor: PhytoHealth Corporation

Clinical • New P2 trial • P2 data • Fatigue • Oncology • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • CRP

PG2 Phase I/II Clinical Study Intravenously Administered in Patients With Advanced Malignancy (clinicaltrials.gov) - P1/2; N=32; Completed; Sponsor: PhytoHealth Corporation

Clinical • New P1/2 trial • P1/2 data • Oncology • IL2 • IL6 • TGFB1

PG2 Treatment for Improving Fatigue Among Advanced Cancer Patients Under Standard Palliative Care (clinicaltrials.gov) - P4; N=250; Recruiting; Sponsor: PhytoHealth Corporation; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Fatigue • Oncology • Palliative care • CRP

PG2 Treatment Among Stage II/III Breast Cancer Patients Receiving Adjuvant Chemotherapy (clinicaltrials.gov) - P2; N=75; Recruiting; Sponsor: PhytoHealth Corporation; Trial completion date: Aug 2020 ➔ Jun 2021; Trial primary completion date: Apr 2020 ➔ Dec 2020

Clinical • Trial completion date • Trial primary completion date • Breast Cancer • Fatigue • Hematological Disorders • Neutropenia • Oncology • CSF3

PG2 Treatment Among Stage II/III Breast Cancer Patients Receiving Adjuvant Chemotherapy (clinicaltrials.gov) - P2; N=75; Recruiting; Sponsor: PhytoHealth Corporation; Not yet recruiting ➔ Recruiting; Initiation date: Nov 2017 ➔ Mar 2018

Clinical • Enrollment open • Trial initiation date • Breast Cancer • Fatigue • Hematological Disorders • Neutropenia • Oncology • CSF3

PG2 Treatment Among Stage II/III Breast Cancer Patients Receiving Adjuvant Chemotherapy (clinicaltrials.gov) - P2; N=75; Recruiting; Sponsor: PhytoHealth Corporation; Trial completion date: Apr 2019 ➔ Aug 2020; Trial primary completion date: Apr 2019 ➔ Apr 2020

Clinical • Trial completion date • Trial primary completion date • Breast Cancer • Fatigue • Hematological Disorders • Neutropenia • Oncology • CSF3

PG2 Treatment for Improving Fatigue Among Advanced Cancer Patients Under Standard Palliative Care (clinicaltrials.gov) - P4; N=350; Recruiting; Sponsor: PhytoHealth Corporation; N=250 ➔ 350; Trial primary completion date: Jan 2017 ➔ Jun 2017

Clinical • Enrollment change • Trial primary completion date • Fatigue • Oncology • Palliative care • CRP

PG2 Treatment for Improving Fatigue Among Advanced Cancer Patients Under Standard Palliative Care (clinicaltrials.gov) - P4; N=323; Completed; Sponsor: PhytoHealth Corporation; Recruiting ➔ Completed

Clinical • Trial completion • Fatigue • Oncology • Palliative care • CRP

PG2 Treatment Among Stage II/III Breast Cancer Patients Receiving Adjuvant Chemotherapy (clinicaltrials.gov) - P2; N=75; Not yet recruiting; Sponsor: PhytoHealth Corporation

Clinical • New P2 trial • Breast Cancer • Fatigue • Hematological Disorders • Neutropenia • Oncology • CSF3

PG2 Treatment for Improving Fatigue Among Advanced Cancer Patients Under Standard Palliative Care (clinicaltrials.gov) - P4; N=250; Recruiting; Sponsor: PhytoHealth Corporation; Trial primary completion date: Apr 2014 ➔ Dec 2015

Clinical • Trial primary completion date • Fatigue • Oncology • Palliative care • CRP