A Phase II, Double Blind, Randomized, Placebo-controlled Study of PG2 Injection for the Treatment of moderate-to Severe Fatigue in Patients With Locally Advanced, Recurrent, or Metastatic Breast Cancer Who Are Receiving Infusional Chemotherapy

The objective of this study is to assess the efficacy of weekly PG2 regimen as a complementary treatment for patients with recurrent unresectable (local or regional) or metastatic breast cancer who experienced moderate to severe fatigue while receiving chemotherapies.

开始日期2022-06-15

申办/合作机构

怀特生技新药股份有限公司

NCT03611712

/ Active, not recruiting临床2期

PG2 Concurrent With Chemoradiation for Locally Advanced Esophageal Cancer

The primary objective of this study is to evaluate the efficacy of PG2 concurrent with concurrent chemoradiation therapy (CCRT) for relieving fatigue among locally advanced esophageal cancer patients who are under preoperative chemoradiation therapy at curative setting. This study will be designed to compare the fatigue status between two study arms patients under CCRT.
The secondary objective is to assess the efficacy of PG2 to improve the quality of life of patient during CCRT. Also, the investigators try to determine the effect of PG2 on tumor response post CCRT, disease free survival (DFS) and overall survival (OS) of patients by comparing the above outcome between the two study arms.
The mechanism of immunomodulatory of PG2 and tumor response, DFS and OS for patients with esophageal cancer treated with preoperative CCRT concurrent with or without PG2 will be investigated in add-on study.

开始日期2019-02-19

申办/合作机构

怀特生技新药股份有限公司

NCT02077621

/ Withdrawn临床2期

The Phase II Clinical Study of PG2 Injection for Improving Fatigue in Patients After Palliative Abdominal Surgery for Cancer

PG2 has been approved in Taiwan to treat cancer-related fatigue for advanced cancer patients. The primary objective of this study is to evaluate the efficacy of PG2 on fatigue relief in patients undergoing palliative abdominal surgery for cancer. The secondary endpoints, including the length of hospital stay, postoperative complications, HRQL, inflammatory biomarkers, the duration of antibiotic therapy, mortality during the hospital stay, weight loss and body composition, will be evaluated among these patients.

开始日期2014-02-01

申办/合作机构

怀特生技新药股份有限公司

100 项与 PG2 相关的临床结果

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100 项与 PG2 相关的转化医学

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100 项与 PG2 相关的专利（医药）

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项与 PG2 相关的文献（医药）

2025-07-01·PHYTOMEDICINE

Platycodonis radix polysaccharides suppress progression of high-fat-induced obesity through modulation of intestinal microbiota and metabolites

Article

作者: Zhi, Nannan ; Wang, Jutao ; Zhang, Kailun ; Chang, Xiangwei ; Zha, Liangping ; Gui, Shuangying

BACKGROUND:

Obesity is a prevalent chronic condition worldwide, posing a significant risk to public health. Polysaccharides derived from Platycodonis Radix (PR) have been identified as the primary bioactive compounds in combating obesity, although the underlying molecular mechanisms remain inadequately understood.

PURPOSE:

The purpose of the research is to analyze the potential anti-obesity influnces within PR polysaccharides (PG: PG1 and PG2) by analyzing their impact on gut microbiota (GM) composition, SCFA and BA metabolism, and the regulation of associated gene and protein expression.

STUDY DESIGN AND METHODS:

In this research, 7-week-old male C57BL/6 mice were assigned to a HFD or a control chow diet for 90 days to evaluate the therapeutic effects of PG intervention. Metagenomic analysis was performed to assess GM alterations, while GC-MS and LC-MS were used to quantify SCFA and BA concentrations in cecal contents, respectively. Furthermore, the effects of PG on SCFA- and BA-associated metabolic pathways were examined through qRT-PCR and WB.

RESULTS:

PG1 demonstrated superior efficacy compared to PG2 in reducing HFD-induced obesity and associated metabolic disturbances. High-dose PG1 treatment effectively inhibited weight gain, dyslipidemia, inflammation, liver damage, and fat deposition caused by the HFD. Additionally, PG1 treatment primarily promoted the abundance of SCFA-producing bacteria, enhanced the expression of GPR41 and GPR43 genes, significantly elevated levels of GLP-1 and PYY, and improved circulating leptin and adiponectin levels. The intervention with PG1 notably enhanced the relative abundances of bacteria involved in the production of secondary BAs, such as Lachnospiraceae_NK4A136 and Eubacterium coprostanoligenes. This augmentation facilitated the transformation of primary BAs into secondary forms, diminished the relative expression of intestinal FXR and FGF15, and reduced FGFR4 levels. Consequently, this led to an upregulation of hepatic CYP7A1, accelerating liver cholesterol metabolism and the synthesis of new BAs.

CONCLUSION:

Supplementation with PG1 protects mice from obesity induced by an HFD. The observed protective effects of PG1 appear to be primarily mediated through the activation of the GM-SCFA-GPR pathway and the inhibition of the GM-BA-FXR-FGF15 signaling pathway.

2024-08-01·ANIMAL REPRODUCTION SCIENCE

Influence of early progesterone removal on follicular development, expression of estrus, and pregnancy rates in presynchronized postpartum beef cows

Article

作者: Henry, Darren Dwayne ; Oosthuizen, Nicola ; Ranches, Juliana ; Walker, Madison Blake ; Burato, Samir ; Zoca, Saulo Menegatti ; Ciriaco, Francine Messias ; Goncalves, Lucas Melo ; Fontes, Pedro Levy Piza

The objective of this study was to evaluate the impact of early progesterone removal on pregnancy rates to fixed-time artificial insemination (FTAI) in presynchronized beef cows. Postpartum beef cows (n = 882) were randomly assigned to 1 of 2 treatments: 1) 7&7 Synch: cows received a controlled internal drug release insert (CIDR) and a 25-mg injection of prostaglandin F_2α on day 0, 100 μg of GnRH on day 7, a second injection of prostaglandin F_2α (PG2) at CIDR removal on day 14, and a second injection of GnRH at FTAI 60-66 h after PG2 (day 17); 2) 7&6 Synch: cows received the same treatment as 7&7 Synch; however, CIDR removal occurred in conjunction with PG2 on day 13, while FTAI remained at 60-66 h after CIDR removal (day 16). Ovarian ultrasonography was performed to determine follicle diameter at PG2 and FTAI in a subset of cows (n = 40). Cows exposed to the 7&7 Synch tended to have larger follicle diameter at PG2 compared with 7&6 Synch cows (P = 0.09); however, there were no differences in follicle diameter at FTAI. No differences were determined between treatments for the expression of estrus (7&7 Synch: 61.6 ± 5.30; 7&6 Synch: 54.1 ± 5.45; P = 0.31) or pregnancy rates to FTAI (7&7 Synch: 60.8 ± 3.83; 7&6 Synch: 57.0 ± 3.84; P = 0.42). In conclusion, early removal of progesterone did not impact pregnancy rates in presynchronized beef cows.

2024-06-01·Advanced materials (Deerfield Beach, Fla.)

Dendronized Polymer‐Derived Nanomedicines for Mitochondrial Dynamics Regulation and Immune Modulation

Article

作者: Hou, Xingyu ; Gong, Qiyong ; Zhong, Dan ; Pan, Dayi ; Luo, Kui

Abstract:

The effects of dendron side chains in polymeric conjugates on tumor penetration and antigen presentation are systematically examined. Three polymer‐gemcitabine (Gem) conjugates (pG0‐Gem, pG1‐Gem, pG2‐Gem) are designed and prepared. The pG2‐Gem conjugate uniquely binds to the mitochondria of tumor cells, thus regulating mitochondrial dynamics. The interaction between the pG2‐Gem conjugate and the mitochondria promotes great penetration and accumulation of the conjugate at the tumor site, resulting in pronounced antitumor effects in an animal model. Such encouraging therapeutic effects can be ascribed to immune modulation since MHC‐1 antigen presentation is significantly enhanced due to mitochondrial fusion and mitochondrial metabolism alteration after pG2‐Gem treatment. Crucially, the drug‐free dendronized polymer, pG2, is identified to regulate mitochondrial dynamics, and the regulation is independent of the conjugated Gem. Furthermore, the combination of pG2‐Gem with anti‐PD‐1 antibody results in a remarkable tumor clearance rate of 87.5% and a prolonged survival rate of over 150 days, demonstrating the potential of dendronized polymers as an innovative nanoplatform for metabolic modulation and synergistic tumor immunotherapy.

项与 PG2 相关的新闻（医药）

2024-09-16

·PRNewswire

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

TAIPEI and BARCELONA, Spain, Sept. 16, 2024 /PRNewswire/ -- A groundbreaking study conducted by PhytoHealth Corporation, a leading provider of botanical medicine, has revealed that combining Astragalus Polysaccharides (PG2®Lyo. Injection) with standard concurrent chemoradiotherapy (CCRT) significantly improves survival rates for patients with advanced esophageal cancer. The study enrolled 38 patients with stage IIb to IIIb esophageal cancer. Participants were randomly assigned to receive either CCRT alone or CCRT combined with PG2, a proprietary extract of Astragalus membranaceus roots developed by PhytoHealth Corporation. 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. 'These findings offer a new hope for patients with esophageal cancer,'' said Dr. Wen-Chieh Huang, Chief of Division of Thoracic Surgery at Mackay Memorial Hospital, Taiwan and the Principal Investigator of the clinical trial for PG2, a drug for cancer-related fatigue (CRF) relief developed by PhytoHealth Corporation, Taiwan. "PG2 has the potential to become a valuable addition to the standard treatment regimen, and can achieve improved patient outcomes.'' The data will be presented as a poster at the prestigious 2024 ESMO Congress. [ESMO abstract link]. Dr. Huang noted that treatment options for esophageal cancer patients are relatively limited compared to those for other cancers. However, this study has shown that PG2 combination therapy can reduce inflammation markers in the blood, decrease the differentiation of macrophages towards the M2 type, and even help shrink tumors while improving survival rates. This represents a significant breakthrough in the treatment of esophageal cancer. Dr. Huang further added that esophageal cancer patients often face tremendous challenges during treatment, with many unable to complete their therapy. However, by incorporating CRF medication, most patients were able to regain their strength, complete the full courses of cancer treatment, and achieve the expected therapeutic effects. Esophageal cancer is a challenging disease with high recurrence rates and poor survival outcomes. PG2, previously established as a treatment for cancer-related fatigue (already approved by Taiwan Food and Drug Administration) has shown promise as a potential treatment enhancer. This latest discovery marks a significant advancement in the ongoing battle against this challenging cancer. About PhytoHealth Corporation PhytoHealth Corporation is a leader in the development and manufacturing of botanical medicine and natural health products based in Taiwan. With a focus on scientific research and innovation, PhytoHealth is committed to providing safe, effective, and high-quality products that support overall health and well-being. Contact: Alison [email protected] Logo - WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

临床结果

100 项与 PG2 相关的药物交易

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适应症	国家/地区	公司	日期
疲劳	中国台湾	怀特生技新药股份有限公司	2012-12-31
白细胞减少	中国	Oxford PharmaGenesis Ltd.	2004-12-31

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适应症	最高研发状态	国家/地区	公司	日期
晚期癌症	临床3期	中国台湾	怀特生技新药股份有限公司	2007-08-01
局部晚期乳腺癌	临床2期	中国台湾	怀特生技新药股份有限公司	2022-06-15
食管鳞状细胞癌	临床2期	中国台湾	怀特生技新药股份有限公司	2019-02-19
局部晚期恶性肿瘤	临床2期	中国台湾	怀特生技新药股份有限公司	2019-02-19
脑卒中	临床2期	中国台湾	怀特生技新药股份有限公司	2012-06-01
慢性特发性血小板减少性紫癜	临床2期	中国台湾	怀特生技新药股份有限公司	2008-09-01
免疫性血小板减少症	临床2期	中国台湾	怀特生技新药股份有限公司	2008-09-01
复发癌	临床2期	中国台湾	怀特生技新药股份有限公司	2001-12-01
出血性卒中	临床1期	中国台湾	怀特生技新药股份有限公司	2011-03-01