Genistein(Genistein) - 药物靶点：Top II_在研适应症：肺损伤，新冠肺炎后遗症，肺纤维化_专利_临床

概要

基本信息

药物类型

小分子化药

别名

4',5,7-trihydroxyisoflavone、5,7,4'-trihydroxyisoflavone、5,7-dihydroxy-3-(4-hydroxyphenyl)-4H-1-benzopyran-4-one

+ [12]

靶点

Top II

作用方式

抑制剂、刺激剂

作用机制

Top II抑制剂(拓扑异构酶II抑制剂)、Tyrosine kinase inhibitors、细胞凋亡刺激剂

治疗领域

肿瘤感染呼吸系统疾病+ [3]

在研适应症

肺损伤新冠肺炎后遗症肺纤维化+ [6]

非在研适应症

急性放射综合征前列腺腺癌晚期恶性实体瘤+ [5]

原研机构

The Henry M. Jackson Foundation

在研机构

Lawson Health Research Institute

National Institutes of Health

Humanetics Corp.

+ [1]

非在研机构

National Cancer Institute

Uman Pharma, Inc.

最高研发阶段临床2期

首次获批日期-

最高研发阶段(中国)-

特殊审评快速通道 (美国)

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结构/序列

分子式C15H10O5

InChIKeyTZBJGXHYKVUXJN-UHFFFAOYSA-N

CAS号446-72-0

关联

31

项与 Genistein 相关的临床试验

NCT06741345

/ Recruiting临床1期

A Phase 1 Multiple Ascending Dose and Food Effect Trial of BIO 300 Oral Suspension in Healthy Volunteers

This is a two-part study of BIO 300 Oral Suspension in healthy male and female volunteers. The first part is a multiple ascending dose (MAD) study to test the safety, pharmacokinetics (PK) and pharmacodynamics (PD) of the drug when given as daily doses over 14 days. The study will enroll three cohorts each receiving a different daily dose: 2000 mg, 3000 mg, or 4000 mg. A fourth group may be added depending on results on the first three cohorts. Each cohort will include 10 participants (5 men, 5 women), with at least 8 completing all study steps. Participants will follow a special diet low in soy-based foods and will fast before certain doses. Blood samples and health checks will be done throughout the study to assess safety, drug is absorption and distribution in the body (PK), and its effects (PD). Safety will be reviewed after each group finishes to decide if the next dose level is safe to proceed.
The second part of the study is a food effect study to examine how food effects the PK of a single dose of BIO 300 Oral Suspension. This study will enroll 16 participants (8 men, 8 women) and will be split into two groups: one group will take the drug after fasting for 10 hours and the other will take the drug after eating a high-fat meal. After a 7-day break, participants will switch conditions (the previously fasted group will take the drug with food, and the previously fed group will take the drug after fasting). Blood samples and health checks will measure how food influences drug absorption (PK) and safety. Both the MAD study and food effect study aim to ensure the drug is safe and provide data on how it behaves in the body under different conditions.

开始日期2024-12-23

申办/合作机构

Humanetics Corp.

NCT06634108

/ Recruiting临床1/2期IIT

Cardiovascular Genistein Therapy for Heart Failure Inflammation

This Phase 1b/2a study aims to investigate the safety and efficacy of genistein in patients with Transthyretin (TTR) Amyloidosis. The focus is on its impact on inflammatory and cardiometabolic biomarkers, along with the effects on cardiac function and exercise capacity.
Blood samples will be collected at baseline, following each dose of genistein, and after a six-week placebo washout period. These samples will undergo extensive analyses, including profiling for inflammatory cytokines and novel molecular markers, and routine tests like CBC, Chem 7, LFT, HbA1c, NT-proBNP, CRP, troponin T, and serum TTR. RNA-seq analyses on peripheral blood mononuclear cells (PBMCs) and isolation of plasma exosomes for inflammatory biomarkers are also part of the protocol.
Following ESC/AHA guidelines, echocardiography will assess cardiac structure and function, focusing on the left and right ventricles and valvular function. Additionally, exercise capacity will be evaluated through a standardized 6-minute walk test, and NT-proBNP levels will be measured as a cardiac stress biomarker.
The trial will include an 18-week follow-up period post-enrolment, with the primary endpoint being the change in inflammatory markers from baseline to three months. Secondary endpoints are cardiac function and exercise capacity changes over the same timeframe. This study aims to provide significant insights into genistein's therapeutic potential for TTR Amyloidosis and its broader implications in managing heart failure.
Following ethical committee approval and written informed consent, the Investigators aim is to enroll 40 participants. This is an open-label study. Each patient will receive genistein by mouth: 250 mg twice a day for 4 weeks (500 mg total/day), 500 mg twice a day for 4 weeks (1000 mg total/day), and 750 mg twice a day (1500 mg total/day) for an additional 4 weeks. This will be followed by a 6-week washout period to conclude the study. An 18-month study is anticipated based on the average enrollment rates. Results from this study are expected to offer critical insights for future larger studies.

开始日期2024-09-27

申办/合作机构

Lawson Health Research Institute

[+1]

NCT06501768

/ Recruiting临床1/2期IIT

A Pilot Clinical Trial of Cardiovascular Genistein Therapy for Heart Failure Inflammation

This Phase 1b/2a open-label study is designed to assess the safety and efficacy of genistein in patients with heart failure (HF). The investigation will focus on its impact on inflammatory and cardiometabolic biomarkers, as well as its effects on cardiac function and exercise capacity.
Blood samples will be collected at baseline, following each administration of genistein, and after a six-week placebo washout period. These samples will be subjected to comprehensive analyses to evaluate inflammatory cytokines and novel molecular markers. Routine tests, including Complete Blood Count (CBC), Basic Metabolic Panel (Chem 7), Liver Function Tests (LFT), Hemoglobin A1c (HbA1c), N-terminal pro b-type natriuretic peptide (NT-proBNP), C-Reactive Protein (CRP), and troponin T will be performed. Advanced assessments will include RNA sequencing (RNA-seq) on peripheral blood mononuclear cells (PBMCs) and the isolation of plasma exosomes to identify inflammatory biomarkers. In addition, a subset of the blood samples will be used to generate induced pluripotent stem cells (iPSCs) to further explore the treatment's impact on heart failure-related inflammatory markers.
Echocardiography, in accordance with the European Society of Cardiology (ESC) and the American Heart Association (AHA) guidelines, will be utilized to evaluate cardiac structure and function with a specific focus on the left and right ventricular functions and valvular integrity. Exercise capacity will be gauged through a standardized six-minute walk test. Levels of NT-proBNP will be measured as an indicator of cardiac stress and function.
Participants will be followed up for 18 weeks post-enrolment, with the primary endpoint being the change in inflammatory markers from baseline to the three-month mark. Secondary endpoints will include changes in cardiac function and exercise capacity over the same period. The trial aims to enrol 40 participants, following ethical committee approval and the acquisition of written informed consent. Each patient will receive genistein at a dosing regimen starting with 250 mg twice daily (BID) for 4 weeks, escalating to 500 mg BID for the subsequent 4 weeks, and 750 mg BID for another 4 weeks, culminating in a 6-week follow-up period.
The insights garnered from this study are expected to be pivotal in guiding future larger-scale studies and to elucidate the therapeutic potential of genistein in the management of heart failure.

开始日期2024-07-01

申办/合作机构

UMC Ljubljana

[+1]

100 项与 Genistein 相关的临床结果

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100 项与 Genistein 相关的转化医学

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100 项与 Genistein 相关的专利（医药）

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22,713

项与 Genistein 相关的文献（医药）

2025-12-31·Journal of the International Society of Sports Nutrition

Survey of nutritional intake status in college baseball players

Article

作者: Aoyama, Yuka ; Tanaka, Mamoru ; Seguchi, Manato ; Iio, Yoko ; Kozai, Hana ; Mori, Yukihiro ; Ito, Morihiro

BACKGROUND:

Diet is closely related to exercise performance. To improve athletes' performance and manage their condition, it is important to get sufficient energy and various nutrients. Thus, it is necessary that athletes understand their nutritional intake status to improve performance and maintain health. This study aimed to explore the nutritional intake status of college baseball players using the Food Frequency Questionnaire (FFQ). Furthermore, the characteristics of their nutritional intake status with respect to athletic performance were evaluated. The result of this studyprovide an opportunity for many under-developed college athletes with irregular lifestyles to recognize and improve their nutritional problems.

METHODS:

In October 2022, a questionnaire survey of 116 male members of a college baseball club was conducted. Of whom, 100 (94.3%) members responded to the survey and 92 (92.0%) provided valid responses. The survey items included basic characteristics such as college grade and type of living arrangement, and information on living conditions, e.g. whether the participant ate breakfast. Nutritional intake was evaluated using the FFQ. Players were divided into the first (regular players in official games), second (bench players in official games), third (players who may join the second or higher team in the future), and fourth teams (players who do not belong to the first to third teams); these categories were used as a marker of performance level. The Kruskal-Wallis test was used to analyze the association between the performance levels of baseball players and the intake of each nutrient and food group obtained by the FFQ. For items that showed a significant association, inter-group comparison was performed using the Dunn-Bonferroni method.

RESULTS:

Carbohydrate intake was greater in the second team compared with the third and fourth teams; saturated and monounsaturated fatty acid intake was higher in the third team compared with the fourth team. Calcium, zinc, copper, manganese, insoluble dietary fiber, iodine, and molybdenum intake was higher in the second team compared with the fourth team. Intake of grains, sugar, dairy, and total energy was significantly higher in the second team compared with the fourth team. However, the protein intake ratio was significantly lower in the second team compared with the fourth team. Overall, energy deficiency and associated deficiencies in protein, fat, and carbohydrate were observed, in addition to dietary fiber and calcium deficiencies. The intake of several food groups appeared inadequate, such as potatoes, beans, vegetables, fruits, eggs, milk, and fats.

CONCLUSIONS:

The study showed deficiencies in the amount of energy and nutrients such as protein, fat, and carbohydrate in college baseball players. Differences in the intake of carbohydrate, calcium, and insoluble dietary fiber among different performance levels were observed, with significantly higher intake of carbohydrate, calcium, and insoluble dietary fiber in the second team. Implementing organized and strategic remedial measures and athletes' identification of nutritional problems are vital to overcome nutritional and energy deficiencies. This study provides useful information for the development of strategies to support nutritional intake in college baseball players.

2025-12-31·Gut Microbes

Maternal probiotic exposure enhances CD8 T cell protective neonatal immunity and modulates offspring metabolome to control influenza virus infection

Article

作者: Delbauve, Sandrine ; Salmon, Isabelle ; Köhler, Arnaud ; Flamand, Véronique ; Allard, Justine ; Cani, Patrice D. ; Brito Rodrigues, Patricia ; Demaret, Florine ; La Palombara, Léa ; Everard, Amandine ; Valentin, Clara ; Verce, Marko

Maternal gut microbiota composition contributes to the status of the neonatal immune system and could influence the early life higher susceptibility to viral respiratory infections. Using a novel protocol of murine maternal probiotic supplementation, we report that perinatal exposure to Lacticaseibacillus rhamnosus (L.rh) or Bifidobacterium animalis subsp. lactis (B.lac) increases the influenza A/PR8 virus (IAV) clearance in neonates. Following either supplementation, type 1 conventional dendritic cells (cDC1) were amplified in the lymph nodes leading to an enhanced IAV antigen-experienced IFN-γ producing effector CD8 T cells in neonates and IAV-specific resident memory CD8 T cells in adulthood. This was compatible with a higher protection of the offspring upon a secondary infection. Interestingly, only mice born to L.rh supplemented mothers further displayed an increased activation of IFN-γ producing virtual memory CD8 T cells and a production of IL-10 by CD4 and CD8 T cells that could explain a better control of the lung damages upon infection. In the offspring and the mothers, no disturbance of the gut microbiota was observed but, as analyzed through an untargeted metabolomic approach, both exposures modified neonatal plasma metabolites. Among them, we further demonstrated that genistein and 3-(3-hydroxyphenyl)propionic acid recapitulate viral clearance or cDC1 activation in neonates exposed to IAV. We conclude that maternal L.rh or B.lac supplementation confers the neonates specific metabolomic modulations with a better CD8 T cell-mediated immune protection against IAV infection.

2025-12-31·PHARMACEUTICAL BIOLOGY

Mechanism of action of genistein on breast cancer and differential effects of different age stages

Review

作者: Pei, Xiujun ; Ma, Bo ; Xiang, Zhebin ; Gong, Weilun ; Wang, Wenjie

CONTEXT:

Genistein, a soy-derived isoflavone, exhibits structural similarities with 17β-estradiol and demonstrates antioxidant, anti-inflammatory, and estrogenic properties. Despite its low bioavailability limiting its clinical application, it shows potential for breast cancer prevention and treatment.

OBJECTIVE:

This review aims to summarize the pharmacological effects and molecular mechanisms of genistein in breast cancer, focusing on its therapeutic potential, strategies to overcome bioavailability limitations, and its role in personalized medicine. Differential impacts among population subgroups are also discussed.

METHODS:

A systematic review was conducted using PubMed, ScienceDirect, and Google Scholar databases. Studies were selected based on their focus on genistein's mechanisms of action, strategies to enhance its bioavailability, and interactions with other therapies.

RESULTS:

Genistein exerted anticancer effects by modulating estrogen receptor β (ERβ), inhibiting angiogenesis, arresting the cell cycle, and inducing apoptosis. Its antioxidant properties help mitigate tumor-associated oxidative stress. Bioavailability enhancement strategies, such as nanoparticle and lipid-based formulations, show promise. Age-dependent effects were evident, with distinct responses observed in prepubertal, menopausal, and postmenopausal populations, underscoring its potential for personalized therapies. Furthermore, genistein influences epigenetic modifications, including DNA methylation and miRNA expression, bolstering its anticancer efficacy.

CONCLUSION:

Genistein is a promising candidate for breast cancer therapy, particularly for personalized treatment. Strategies to enhance bioavailability and further clinical research are essential to optimize its therapeutic potential and evaluate its efficacy in combination therapies.

51

项与 Genistein 相关的新闻（医药）

2025-03-17

·GlobeNewswire-Health Care

Humanetics Selects Lifecore Biomedical to Deliver CDMO Services Supporting Development of BIO 300 for the Prevention of Acute Radiation Syndrome

Humanetics’ Novel Radioprotective Agent Being Developed with Funding from Department of Defense as Radiation Medical Countermeasure (MCM) Lifecore to Carry Out Tech Transfer and Analytical Method Activities, including Filling of Pilot Batch CHASKA, Minn. and MINNEAPOLIS, March 17, 2025 (GLOBE NEWSWIRE) -- Lifecore Biomedical, Inc. (NASDAQ: LFCR) (“Lifecore”), a fully integrated contract development and manufacturing organization (“CDMO”), and Humanetics Corporation (“Humanetics”), an advanced clinical-stage pharmaceutical company, today announced that Humanetics has selected Lifecore to provide a range of CDMO services to support the continued development of BIO 300 for the prevention of acute radiation syndrome. Under the terms of the agreement, Lifecore will conduct technology transfer of the existing fill and finish process for BIO 300, including formulation development, gap assessment, and filling of a pilot batch. Lifecore will also undertake analytical method work including feasibility assessments designed to estimate future development work for the product candidate. “This relationship represents another important example of the momentum that we are generating at Lifecore as we execute against our strategic growth plan. Humanetics’ BIO 300 is the exact type of promising, cutting-edge biopharmaceutical product that we strive to support, and we are gratified to have been selected by the company to provide these services,” said Paul Josephs, chief executive officer of Lifecore. “Additionally, this collaboration between two Minnesota-based life science companies helps shine a spotlight on the impressive medical innovation that is coming out of our state, and we are thrilled to be able to support the important work being advanced by Humanetics.” “We are excited about working with Lifecore in our own backyard, showcasing the exceptional talent and innovation Minnesota has to offer,” said Ronald Zenk, chief executive officer of Humanetics. “Results of this collaboration will help provide critical protection against exposure to radiation for warfighters, First Responders and civilian populations worldwide.” In addition to the acute radiation syndrome program, BIO 300 is currently in late-stage clinical development for the mitigation of impaired pulmonary function in COVID-19 patients recently discharged from the hospital. Humanetics recently announced promising data from a Phase 2 clinical trial of BIO 300. The compound is also in development for oncology applications to protect cancer patients from unintentional side effects caused by radiation therapy. AcknowledgementThe U.S. Army Medical Research Acquisition Activity, 808 Schreider Street, Fort Detrick MD 21702-5014 is the awarding and administering acquisition office. This work was supported by The Assistant Secretary of Defense for Health Affairs endorsed by the Department of Defense, in the amount of $5,132,520 through the Peer Reviewed Medical Research Program under Award Number W81XWH-22-1-0516. Opinions, interpretations, conclusions, and recommendations are those of the author(s) and are not necessarily endorsed by The Assistant Secretary of Defense for Health Affairs endorsed by the Department of Defense. About Lifecore Biomedical Lifecore Biomedical, Inc. (Nasdaq: LFCR) is a fully integrated contract development and manufacturing organization (CDMO) that offers highly differentiated capabilities in the development, fill and finish of sterile injectable pharmaceutical products in syringes, vials, and cartridges, including complex formulations. As a leading manufacturer of premium, injectable-grade hyaluronic acid, Lifecore brings more than 40 years of expertise as a partner for global and emerging biopharmaceutical and biotechnology companies across multiple therapeutic categories to bring their innovations to market. For more information about the company, visit Lifecore’s website at www.lifecore.com. About Humanetics CorporationHumanetics is an advanced clinical-stage pharmaceutical company engaged in the accelerated discovery, development, and commercialization of proprietary drugs in markets with urgent and unmet needs, with a focus on medical countermeasures, radiation modulators for oncology and inflammatory lung diseases. For more information, visit www.humaneticscorp.com. Important Cautions Regarding Forward-Looking Statements This press release contains forward-looking statements regarding future events and our future results that are subject to the safe harbor created under the Private Securities Litigation Reform Act of 1995 and other safe harbors under the Securities Act of 1933 and the Securities Exchange Act of 1934. Words such as “anticipate”, “estimate”, “expect”, “project”, “plan”, “intend”, “believe”, “may”, “might”, “will”, “should”, “can have”, “likely” and similar expressions are used to identify forward-looking statements. In addition, all statements regarding our anticipated future operating and financial expectations, customer opportunities and relationships are forward-looking statements. All forward-looking statements involve certain risks and uncertainties that could cause actual results to differ materially, including such factors among others, as the company’s ability to successfully enact its business strategies, including with respect to installation, capacity generation and its ability to attract demand for its services, and its ability expand its relationship with its existing customers or attract new customers; the impact of inflation on Lifecore’s business and financial condition; changes in business conditions and general economic conditions both domestically and globally, including rising interest rates and fluctuation in foreign currency exchange rates; Lifecore’s ability to access sufficient capital to fund its business strategies; and other risk factors set forth from time to time in Lifecore’s SEC filings, including, but not limited to, the Annual Report on Form 10-K for the year ended May 26, 2024 (the “2024 10-K”). For additional information about factors that could cause actual results to differ materially from those described in the forward-looking statements, please refer to our filings with the Securities and Exchange Commission, including the risk factors contained in the 2024 10-K. Forward-looking statements represent management’s current expectations as of the date hereof and are inherently uncertain. Except as required by law, we do not undertake any obligation to update forward-looking statements made by us to reflect subsequent events or circumstances. Lifecore Biomedical, Inc. Contact Information: Vida Strategic PartnersStephanie Diaz (Investors)415-675-7401sdiaz@vidasp.com Tim Brons (Media)415-675-7402tbrons@vidasp.com Ryan D. Lake (CFO)Lifecore Biomedical952-368-6244ryan.lake@lifecore.com

临床2期放射疗法引进/卖出

2025-01-22

·Business Wire

Humanetics Corporation Announces Positive Phase 2 Clinical Trial Results in COVID-19 Study Aimed at Improving Pulmonary Function

MINNEAPOLIS--( BUSINESS WIRE )--Humanetics Corporation (Humanetics) announced today the results of its Phase 2 clinical trial of BIO 300 Oral Suspension (BIO 300) for the mitigation of impaired pulmonary function in COVID-19 patients recently discharged from the hospital. BIO 300 is an oral drug that patients self-administer daily for 12 weeks following hospital discharge. The study compared the lung function, exercise capacity, and quality of life in COVID-19 survivors who received BIO 300 against a placebo group. The trial enrolled 38 participants across multiple U.S. sites ( NCT04482595 ). Rany Condos, MD, a clinical Professor in the Department of Medicine at NYU Grossman School of Medicine and Director of its Post-COVID Program, served as the lead investigator. Patients previously hospitalized with COVID-19 complications and discharged with residual lung complications (e.g., long COVID) were eligible if enrolled within two years of discharge. Multiple pulmonary function assessments and a patient-reported quality of life questionnaire were used to evaluate BIO 300’s efficacy. Although the study fell short of its planned enrollment of 50 participants, the 20 BIO 300-treated participants within the enrolled cohort of 38 exhibited improved lung function and participant-reported quality of life compared to placebo-treated participants. Key Trial Findings: Improvement in Pulmonary Function: Participants who received BIO 300 demonstrated a statistically significant improvement in pulmonary function at 12 weeks, which was maintained at 12 months, as measured by forced expiratory volume in one second (FEV1). Additionally, clear statistical trends for improved pulmonary function were observed in BIO 300-treated participants at 12 weeks, 6 months, and 12 months, as measured by the diffusing capacity of the lung for carbon monoxide (DLCO) and forced vital capacity (FVC). Quality of life: Participants treated with BIO 300 showed a clear trend toward an improved quality of life as measured by the St. George’s Respiratory Questionnaire at 6 months, which was maintained at 12 months. Safety Profile: BIO 300 treatment was well-tolerated, with adverse events consistent with those expected in this patient population. No new safety concerns were identified during the trial. "We are highly encouraged by the results of this clinical trial, particularly the promising trends in pulmonary function improvement among COVID-19 participants treated with BIO 300," said Michael Kaytor, PhD, Vice President of Research and Development at Humanetics. "We are continuing to evaluate the data to refine our understanding of BIO 300’s efficacy in COVID-19 and its potential applications for improving patient outcomes." BIO 300 is also in development as a medical countermeasure for use by the United States Department of Defense and for oncology applications to protect patients from side effects caused by radiation. "As BIO 300 has been shown to mitigate inflammation of the lungs and pulmonary fibrosis caused by radiation, we believe that the same effect can be shown in COVID-19 patients,” said Ronald J. Zenk, Chief Executive Officer at Humanetics. “We are optimistic that this treatment could be a valuable addition to the ongoing efforts to combat long COVID and other conditions with lung inflammation and are committed to evaluating its impact in future studies.” This project was funded by the National Institute of Allergy and Infectious Diseases, a component of the National Institutes of Health, Department of Health and Human Services, under Contract HHSN272201800011C. About Humanetics Corporation Humanetics is an advanced clinical-stage pharmaceutical company engaged in the accelerated discovery, development, and commercialization of proprietary drugs in markets with urgent and unmet needs, with a focus on medical countermeasures, radiation modulators for oncology and inflammatory lung diseases. For more information, visit www.humaneticscorp.com .

临床2期临床结果放射疗法

2025-01-22

·Business Wire

Humanetics Corporation Announces Positive Phase 2 Clinical Trial Results in COVID-19 Study Aimed at Improving Pulmonary Function

MINNEAPOLIS--( BUSINESS WIRE )--Humanetics Corporation (Humanetics) announced today the results of its Phase 2 clinical trial of BIO 300 Oral Suspension (BIO 300) for the mitigation of impaired pulmonary function in COVID-19 patients recently discharged from the hospital. BIO 300 is an oral drug that patients self-administer daily for 12 weeks following hospital discharge. The study compared the lung function, exercise capacity, and quality of life in COVID-19 survivors who received BIO 300 against a placebo group. The trial enrolled 38 participants across multiple U.S. sites ( NCT04482595 ). Rany Condos, MD, a clinical Professor in the Department of Medicine at NYU Grossman School of Medicine and Director of its Post-COVID Program, served as the lead investigator. Patients previously hospitalized with COVID-19 complications and discharged with residual lung complications (e.g., long COVID) were eligible if enrolled within two years of discharge. Multiple pulmonary function assessments and a patient-reported quality of life questionnaire were used to evaluate BIO 300’s efficacy. Although the study fell short of its planned enrollment of 50 participants, the 20 BIO 300-treated participants within the enrolled cohort of 38 exhibited improved lung function and participant-reported quality of life compared to placebo-treated participants. Key Trial Findings: Improvement in Pulmonary Function: Participants who received BIO 300 demonstrated a statistically significant improvement in pulmonary function at 12 weeks, which was maintained at 12 months, as measured by forced expiratory volume in one second (FEV1). Additionally, clear statistical trends for improved pulmonary function were observed in BIO 300-treated participants at 12 weeks, 6 months, and 12 months, as measured by the diffusing capacity of the lung for carbon monoxide (DLCO) and forced vital capacity (FVC). Quality of life: Participants treated with BIO 300 showed a clear trend toward an improved quality of life as measured by the St. George’s Respiratory Questionnaire at 6 months, which was maintained at 12 months. Safety Profile: BIO 300 treatment was well-tolerated, with adverse events consistent with those expected in this patient population. No new safety concerns were identified during the trial. "We are highly encouraged by the results of this clinical trial, particularly the promising trends in pulmonary function improvement among COVID-19 participants treated with BIO 300," said Michael Kaytor, PhD, Vice President of Research and Development at Humanetics. "We are continuing to evaluate the data to refine our understanding of BIO 300’s efficacy in COVID-19 and its potential applications for improving patient outcomes." BIO 300 is also in development as a medical countermeasure for use by the United States Department of Defense and for oncology applications to protect patients from side effects caused by radiation. "As BIO 300 has been shown to mitigate inflammation of the lungs and pulmonary fibrosis caused by radiation, we believe that the same effect can be shown in COVID-19 patients,” said Ronald J. Zenk, Chief Executive Officer at Humanetics. “We are optimistic that this treatment could be a valuable addition to the ongoing efforts to combat long COVID and other conditions with lung inflammation and are committed to evaluating its impact in future studies.” This project was funded by the National Institute of Allergy and Infectious Diseases, a component of the National Institutes of Health, Department of Health and Human Services, under Contract HHSN272201800011C. About Humanetics Corporation Humanetics is an advanced clinical-stage pharmaceutical company engaged in the accelerated discovery, development, and commercialization of proprietary drugs in markets with urgent and unmet needs, with a focus on medical countermeasures, radiation modulators for oncology and inflammatory lung diseases. For more information, visit www.humaneticscorp.com .

临床2期临床结果放射疗法

100 项与 Genistein 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D11680	Genistein	-	DB01645

研发状态

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
甲状腺素运载蛋白淀粉样变心肌病	临床2期	加拿大	Lawson Health Research Institute	2024-09-27
甲状腺素运载蛋白淀粉样变心肌病	临床2期	加拿大	Greenstone Biosciences, Inc.初创企业	2024-09-27
心脏衰竭	临床2期	斯洛文尼亚	Greenstone Biosciences, Inc.初创企业	2024-07-01
肺损伤	临床2期	美国	Humanetics Corp.	2022-04-27
新冠肺炎后遗症	临床2期	美国	Humanetics Corp.	2020-11-11
肺纤维化	临床2期	美国	Humanetics Corp.	2020-11-11
非肌层浸润性膀胱肿瘤	临床2期	美国	National Institutes of Health	2017-05-19
晚期恶性实体瘤	临床2期	加拿大	Uman Pharma, Inc.	2012-11-01
非小细胞肺癌	临床2期	加拿大	Uman Pharma, Inc.	2012-11-01
前列腺腺癌	临床2期	美国	National Cancer Institute	2011-12-01

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临床结果

适应症

分期

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT01489813 (CTgov)	临床2期	非肌层浸润性膀胱肿瘤	36	sugar pill (Sugar Pill)	糧觸淵製願淵繭襯積鏇(範簾膚廠鹹艱醖積膚願) = 鹽製鑰遞鬱鹽鏇遞製齋壓憲憲鹹窪襯壓艱鏇鑰 (積願夢淵廠膚範鑰鬱鑰, 鹽觸築廠艱鏇範廠壓窪 ~ 觸夢淵築衊選鹽淵鹽獵) 更多	-	2024-07-25
				Genistein (Genistein Supplement)	糧觸淵製願淵繭襯積鏇(範簾膚廠鹹艱醖積膚願) = 齋鏇製鹹鹹醖壓遞鏇鑰壓憲憲鹹窪襯壓艱鏇鑰 (積願夢淵廠膚範鑰鬱鑰, 願襯鏇選窪築鏇鑰鹹網 ~ 鬱顧夢觸鑰憲網顧鬱繭) 更多
EULAR2024	N/A	大动脉炎	-	Genistein	簾遞蓋衊範願選繭繭齋(繭膚鏇夢壓蓋願選遞鹹) = 鑰襯鹽構醖蓋網鏇衊製製願鏇繭範夢選廠膚簾 (鹹齋夢廠夢簾醖鑰範餘 )	积极	2024-06-05
NCT02624388 (UVA-Gen001, CTgov)	临床2期	霍奇金淋巴瘤 \| 急性淋巴细胞白血病 \| 肾母细胞瘤 ... 更多	4	Placebo+Genistein (Arm A: Genistein Followed by Placebo)	鬱鹽簾餘醖顧齋蓋廠積(襯鹹築壓壓築鹹鏇遞夢) = 壓鬱糧廠鹽構範膚淵範簾觸鹽艱鏇壓簾淵範醖 (糧夢鑰繭餘餘鹹餘醖網, 1.26) 更多	-	2024-05-06
				Placebo+Genistein (Arm B: Placebo Followed by Genistein)	鬱鹽簾餘醖顧齋蓋廠積(襯鹹築壓壓築鹹鏇遞夢) = 鹹獵艱淵衊繭襯齋糧糧簾觸鹽艱鏇壓簾淵範醖 (糧夢鑰繭餘餘鹹餘醖網, 2.08) 更多
NCT04650555 (CTgov)	临床1期	急性放射综合征	34	BIO 300 Oral Powder (Single Ascending Dose Cohort 1)	壓膚繭憲獵膚齋選鑰膚(窪鑰蓋網鬱夢鹽鏇鹽壓) = 憲窪構壓願構鑰艱願廠築襯積夢觸鹹獵願選艱 (膚積膚衊鬱顧製憲醖顧, 9.3) 更多	-	2024-05-03
				BIO 300 Oral Powder (Single Ascending Dose Cohort 2)	醖簾鑰範鏇餘廠築積餘 = 顧繭簾襯範遞糧獵顧憲製獵艱膚廠鹽糧範壓構 (繭鬱鬱鑰蓋蓋鬱廠鑰願, 鑰鹹齋餘築窪選憲觸淵 ~ 鏇衊構範觸繭範網築糧) 更多
NCT02567799 (NSCLC, CTgov)	临床1/2期	非小细胞肺癌	21	BIO (BIO 300 Oral Suspension (500 mg/Day))	鹽顧廠鬱網糧鹽鹹鹹範 = 積糧遞壓願餘鏇遞齋網廠獵淵遞醖餘憲積構鑰 (構窪鹹鬱膚醖遞鏇餘鏇, 淵願壓構壓淵壓淵憲鹹 ~ 夢鬱積鹹構窪網憲壓繭) 更多	-	2023-12-20
				BIO (BIO 300 Oral Suspension (1000 mg/Day))	鹽顧廠鬱網糧鹽鹹鹹範 = 襯壓糧醖積窪襯製廠網廠獵淵遞醖餘憲積構鑰 (構窪鹹鬱膚醖遞鏇餘鏇, 顧鏇蓋製淵繭鬱積積簾 ~ 鏇簾網繭膚醖夢窪膚鹽) 更多
NCT02567799 (Biospace) 人工标引	临床1/2期	非小细胞肺癌	21	BIO 300	範築鹹淵鏇構壓網艱淵(鹹餘膚製醖鏇製鏇齋膚) = 鹽膚壓範遞製製積齋衊繭艱艱艱夢衊艱膚遞憲 (艱鹹積醖壓願醖鏇膚網 ) 更多	积极	2023-09-19
NCT02766478 (GeniPro, CTgov)	临床2期	代谢综合征 \| 前列腺癌	10	Genistein (Genistein)	餘觸構遞積齋夢壓餘餘(願鏇顧遞壓鏇齋積選膚) = 憲遞襯糧壓觸憲築齋範築築鏇選選簾淵積襯網 (衊鬱遞襯製構餘餘築夢, 艱簾顧獵憲選遞鏇夢鏇 ~ 襯獵顧糧鏇願膚構淵繭) 更多	-	2022-09-27
				Placebo (Placebo)	餘觸構遞積齋夢壓餘餘(願鏇顧遞壓鏇齋積選膚) = 餘範鏇遞鑰鹽衊衊構選築築鏇選選簾淵積襯網 (衊鬱遞襯製構餘餘築夢, 夢積襯構鹽網選鬱繭鹽 ~ 構衊壓願鹹齋鬱顧鹹艱) 更多
NCT04650555 (BusinessWire) 人工标引	临床1期	-	34	BIO 300	壓壓積選艱築鏇壓醖鏇(鏇衊遞積餘憲構築夢衊) = increase survival in persons exposed to lethal levels of radiation 網觸糧夢鑰醖遞憲繭遞 (選鹽願襯鹽選蓋鑰製觸 )	积极	2021-09-22
NCT01985763 (Pubmed \| Cancer Chemother Pharmacol) 人工标引	临床1/2期	转移性结直肠癌	13	FOLFOX+Bevacizumab+Genistein	選網壓願構選鹹糧壓糧(簾憲網衊築膚鹹顧壓鏇) = 1patirent (grade 3 hypertension) 獵簾餘顧醖獵積壓艱醖 (鹽鬱壓糧襯膚淵齋鏇觸 ) 更多	积极	2019-09-01
NCT00287690 (CTgov)	临床2/3期	冠心病	71	Genistein (Genistein)	網繭蓋選願積觸構衊憲(繭齋糧觸衊窪衊遞製網) = 壓齋廠壓遞網齋艱鏇觸選積網醖鏇繭製糧淵繭 (蓋獵積齋鑰願鹽願齋願, 0.4) 更多	-	2019-08-05
				Placebo (Placebo)	網繭蓋選願積觸構衊憲(繭齋糧觸衊窪衊遞製網) = 艱廠構願醖鑰襯襯醖齋選積網醖鏇繭製糧淵繭 (蓋獵積齋鑰願鹽願齋願, 0.4) 更多