Surgical resection and liver transplantation are the primary curative treatments for hepatocellular carcinoma (HCC). However, many patients are ineligible for these treatments due to advanced disease, social factors, or limited availability of liver donors. Therefore, for patients with unresectable HCC, locoregional therapies like transarterial radioembolization (TARE with Y90) are considered the next best non-operative option, especially when the cancer remains confined to the liver. Despite the use of these liver-directed therapies, relapse rates and mortality remain high, underscoring the need for new predictive biomarkers and therapeutic targets, including immune modulation.
The rationale behind NP-101 (TQ formula) stems from its immune modulatory properties as a potent drug derived from a natural substance, black seed or Nigella Sativa. Previous studies have demonstrated its immune modulation and anti-cancer effects, showing promise in preclinical models of HCC. In a randomized phase 2 study conducted in Covid patients, NP-101 exhibited safety and significantly increased T effector cells (CD4+ and CD8+ T lymphocytes), resulting in accelerated recovery. The immune modulation effect of NP-101, observed in the Covid study, and its potential to enhance CD4+ and CD8+ T effector lymphocytes can potentially modify the immune microenvironment and improve outcomes in locally advanced HCC patients undergoing Y90 treatment.
This study will investigate the safety, efficacy and maximum tolerated dose of NP-101 in patients with unresectable hepatocellular carcinoma.
The dosing scheme for NP-101 in this study will follow a Bayesian Optimal Interval design. Based on the target dose-limiting toxicity (DLT) rate of 30% and assuming a 3+3 design, three subjects will be sequentially enrolled at each of the 3 dose levels (beginning with 3g) until at least one DLT occurs.
If no DLTs occur, dosing will be escalated to the next dose level for the next three enrolled subjects. At either of the two dose levels, if 1 DLT occurs, three more subjects will be enrolled at that dose level. If no DLTs occur in these subjects, three more subjects will be enrolled at the next highest dose level. Dosing escalation will be stopped if two or more total DLTs occur at any dose level. The maximum tolerated dose (MTD) will be one dose level below the dose level at which two or more DLTs occurred.

开始日期2025-02-01

申办/合作机构

University of Florida

[+2]

NCT05785390 / Recruiting临床2期

A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Phase IIa/IIb Study to Evaluate the Safety, Tolerability, and Efficacy of NP-101 in Treating High-Risk Participants Who Have Tested Positive for Novel Coronavirus 2019.

The goal of this clinical trial is to evaluate the safety, tolerability, and efficacy of NP-101 in treating high-risk participants who have tested positive for Covid-19. The main question[s] it aims to answer are:
* To evaluate the safety of NP-101, as well as establish the maximum tolerated dose in high risk Covid-19 positive patients.
Participants will [describe the main tasks participants will be asked to do, treatments they'll be given and use bullets if it is more than 2 items]. If there is a comparison group: Researchers will compare [insert groups] to see if [insert effects].

开始日期2023-02-22

申办/合作机构

Novatek Pharmaceuticals, Inc.初创企业

NCT05262556 / Active, not recruiting临床1期IIT

Pilot Study of NP-101 (TQ Formula) in Combination With Nivolumab and Ipilimumab in Advanced and Metastatic Extra-pulmonary Neuroendocrine Carcinomas (EP-NECAs)

A pilot study to evaluate the anti-tumor efficacy of this novel combined regimen (NP-101 TQ Formula plus nivolumab and ipilimumab) in the second-line setting for EP-NECA. NP-101 (TQ Formula) (TQ, C10H12O2) is the main bioactive component of the black seed (Nigella sativa, Ranunculaceae family) and has anti-oxidant, anti-angiogenic effects.

开始日期2022-12-15

申办/合作机构

The Case Comprehensive Cancer Center

[+1]

100 项与 Nigella Sativa(Novatek Pharmaceuticals) 相关的临床结果

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100 项与 Nigella Sativa(Novatek Pharmaceuticals) 相关的转化医学

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100 项与 Nigella Sativa(Novatek Pharmaceuticals) 相关的专利（医药）

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项与 Nigella Sativa(Novatek Pharmaceuticals) 相关的文献（医药）

2024-09-21·Healthcare

An Assessment of the Clinical Efficacy of a Topical Application of 5% Thymoquinone Gel for Plaque-Induced Gingivitis Patients: A Randomized Controlled Clinical Trial.

Article

作者: Almehmadi, Ahmad H ; Aljohani, Khalid

BACKGROUND:

Gingival diseases, encompassing a spectrum of oral health concerns, represent a prevalent issue within the global population. Despite their widespread occurrence, the research landscape concerning effective interventions, particularly those rooted in herbal products, remains somewhat limited. Addressing this knowledge gap, the current study undertook a comprehensive evaluation aimed at assessing the clinical efficacy of a novel intervention: a 5% thymoquinone (TQ) gel. This investigation specifically focused on the application of TQ gel as an adjunctive measure to the standard protocol of scaling (SC) in individuals afflicted with plaque-induced gingivitis. Through rigorous examination and analysis, this study seeks to provide valuable insights into the potential utility and therapeutic benefits of this herbal-based intervention in managing gingival diseases.

OBJECTIVE:

To evaluate the efficacy of 5% TQ gel using a novel liposome drug delivery as a topical application following SC in gingivitis patients.

METHODS:

A double-blinded, parallel, randomized controlled clinical trial. The study was performed at the Faculty of Dentistry, King Abdulaziz University, and Qassim University, Saudi Arabia. This trial enrolled 63 participants in an age group between 18 and 40 years attending the outpatient clinics of the Faculty of Dentistry, Qassim University, Saudi Arabia, and a clinical diagnosis of gingivitis was made. The enrolled subjects were categorized into three groups: Group I-TQ gel with SC, Group II-Placebo with SC, and Group III-SC alone, and clinical outcomes were measured at baseline and two-week follow-up visits. Plaque index (PI), papillary bleeding index (PBI), and any adverse events with TQ gel are categorized as mild, moderate, and severe. 63 patients. Group I (n = 21); Group II (n = 21); Group III (n = 21).

RESULTS:

The paired t-test compared the mean differences in PI and PBI at two time points and it was observed that there were significant differences in Group I with p-values of 0.04 and 0.05, respectively. A one-way ANOVA test was performed and it showed significant differences in the mean scores between the three groups for PI (p-value-0.01) and PBI (p-value-0.05). The post hoc Tukey's test compared the mean differences in PI and PBI between the groups and the results were in favor of Group I which used TQ gel with SC.

CONCLUSIONS:

The clinical trial concluded that the plaque and gingival bleeding scores were significantly reduced in the group of patients who intervened with TQ gel following SC when compared to SC-alone and placebo groups. Also, there were significant reductions in the scores from the baseline to the two-week follow-up visit in patients treated with TQ gel and SC.

2024-09-01·Heliyon

Nigella sativa extract abrogates traumatic brain injury-induced memory impairment in adult mice

Article

作者: Kiyani, Mubin Mustafa ; Khan, Rifat Ullah ; Khan, Hamid ; Shah, Shahid Ali ; Bashir, Shahid ; Jawad, Sahibzada Muhammad

Background:

Traumatic brain injury (TBI) is an increasing widespread cause of disability and mortality, typically leading to dementia and memory impairment.

Objective:

This study aims to investigate the neuroprotective potential of Nigella sativa extract against TBI induced memory impairment in adult albino mice.

Methods:

Adult male mice were divided into four groups randomly: Control, Nigella sativa extract alone, TBI alone and TBI plus Nigella sativa extract. TBI induction was carried out in mice using a weight dropping method then Nigella sativa extract (10 mg/kg) was administered intraperitoneally for two weeks. Morris water maze and Y-maze tests were used to measure memory improvement ability and Western blot technique was used to analyse the neuroinflammatory and synaptic protein markers.

Results:

Nigella sativa extract significantly decreased phosphorylated c-Jun N-terminal kinase (p-JNK), Tumor necrosis factor-alpha (TNF-α), and nuclear factor kappa B (NF-κB) proteins to reduce TBI-induced neuroinflammation accompanied by the restoration of both pre- and post-synaptic protein expression in adult mice model. Furthermore, Nigella sativa extract enhanced both short and long-term spatial memory against TBI in adult mice model.

Conclusion:

Nigella sativa extract abrogated neuroinflammation mediated memory impairment in TBI mice model. Further research is needed to determine Nigella sativa extract ingredients detail completely and to understand its mechanisms of neuroprotection in reducing memory impairments associated with traumatic brain injury and other neurodegenerative diseases.

2024-06-01·NEUROSCIENCE LETTERS

Effect of cyclodextrin-complexed lyophilized nanosuspension of Nigella sativa seeds oleoresin on chronic unpredictable mild stress (CUMS)-induced depression in mice

Article

作者: Logesh, Rajan ; Solanki, Deepak ; Serva Peddha, Muthukumar ; Mehdi, Seema ; Nag, Kaustav ; Shakeel, Faiyaz ; Fatima Roohi, Tamsheel ; Kinattingal, Nabeel

Depression is a prevalent global health concern necessitating alternative approaches to conventional antidepressant medications due to its associated adverse effects. Nigella sativa (NS) is recognized for its potential as an antidepressant, offering a promising solution with fewer side effects. This study investigated the antidepressant efficacy of cyclodextrin-complexed lyophilized nanosuspension of NS oleoresin (NSOR) in a murine model of chronic unpredictable mild stress (CUMS)-induced depression. This study sought to evaluate and contrast the antidepressant potential of the nano-NSOR with that of the NS ethanolic extract (NSEE). The prepared nano-NSOR was characterized physicochemically and evaluated for in vitro drug release and in vivo antidepressant activity. The particle size of nano-NSOR was determined to be 164.6 nm. In vitro drug release studies suggested the higher drug release from nano-NSOR (90.15 % after 72 h) compared to the native NSOR (59.55 % after 72 h). Furthermore, nano-NSOR exhibited a more pronounced antidepressant effect than NSEE in the context of CUMS-induced depression. This study highlights a potential alternative for managing depression, addressing the need for improved antidepressant treatments with reduced side effects. These results suggest that nano-NSOR ameliorates CUMS-induced depression by modulating neurotransmitter levels, reducing inflammation, and enhancing neuroprotection.

项与 Nigella Sativa(Novatek Pharmaceuticals) 相关的新闻（医药）

2022-11-28

·BioSpace

Therapeutic Solutions International Granted Broad Patent on Treatment of Neurodegenerative Conditions

Phase III Adult Stem Cell Company Covers Ability of its COVID-19 Nutraceutical to Repair Injured Brain Cells and Stimulate Endogenous Brain Stem Cells ELK CITY, Idaho--(BUSINESS WIRE)-- Therapeutic Solutions International (TSOI) announced today issuance of United States Patent # 11,504,4101 which in its broadest claim covers: “A method of protecting from damage and/or of regenerating a neurological tissue, comprising administration of: (a) pterostilbene, and/or blueberry, and/or an extract thereof; (b) green tea and/or an extract thereof; (c) Nigella sativa and/or an extract thereof; and (d) broccoli and/or an extract thereof.” Dependent patent claims cover various mechanisms of neural protection and regeneration, as well as treatment of different pathologies which cause neural deterioration. The Company views the issuance of these claims in an extremely positive manner because they not only cover the composition of matter of its commercially available immune modulatory nutraceutical QuadraMune®, but they also cover individual ingredients that comprise QuadraMune®. “If one searches pterostilbene, nigella sativa, sulforaphane, or EGCG, you can see that these ingredients are already used for a variety of nutraceutical applications. The fact that we have an issued patent covering their use for brain regeneration both alone and together, positions the Company strongly in this crowded space,” said Dr. James Veltmeyer, Chief Medical Officer of the Company, and co-inventor on the patent. “We are in a very rare and unique situation in that after we filed the patent, numerous independent academic institutes have confirmed the biological properties of these ingredients that we covered in the patent and now have been granted to us for conceptualizing them before anyone else.” There are many examples of the science behind QuadraMune® being confirmed by independent groups. One example was the work of Johns Hopkins University which showed COVID-19 virus inhibition by one of the ingredients in QuadraMune® after the Company filing its patents2. This is the third patent issued surrounding QuadraMune® and its ingredients. The first covered therapeutic immune modulation and inhibition of the immune suppressive enzyme indolamine 2,3 deoxygenase (#11,229,6743), and the second patent covered the prevention and treatment of COVID-19 (#11,266,7074). “As a Company, our main mission is to hyper-accelerate scientific and corporate progress which is essential for delivering life-saving medicine to patients who have no other options. Whether it is successful treatment of epilepsy5, Emergency INDs for treatment of COVID-196, or treatment of cancer patients with ValloVax7, we are happy for the support our efforts are receiving,” said Timothy Dixon, President, and CEO of the Company and co-inventor. “The granting of these broad claims in our recently issued patent provides strong support for the scientific innovation of our work and we believe will accelerate our commercial and patient success.” About Therapeutic Solutions International, Inc. Therapeutic Solutions International is focused on immune modulation for the treatment of several specific diseases. The Company's corporate website is . 1 Neuroprotection and neuroregeneration by pterostilbene and compositions thereof 2 John Hopkin’s University Publishes Efficacy of QuadraMune™ Ingredient Sulforaphane at Inhibiting Coronavirus in Laboratory Studies 3 Nutraceuticals for suppressing indolamine 2,3 deoxygenase 4 Nutraceuticals for the prevention, inhibition, and treatment of SARS-CoV-2 and associated COVID-19 5 Therapeutic Solutions International Announces Successful Treatment of Epilepsy in Animal Model and Complete Cessation of Seizures in Treatment Resistant Patient 6 Therapeutic Solutions International Granted Emergency IND by FDA for Expanded Patient Access to JadiCell™ Universal Donor Stem Cell for COVID-19 ARDS Outside of Ongoing Phase III Clinical Trial 7 Therapeutic Solutions International Spin-Off Res Nova Bio Collaborates with Veltmeyer MD Inc. to Provide Breast Cancer Patients Access to Novel Cancer Immunotherapy

免疫疗法临床3期

100 项与 Nigella Sativa(Novatek Pharmaceuticals) 相关的药物交易

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适应症	最高研发状态	国家/地区	公司	日期
新型冠状病毒感染	临床2期	美国	Novatek Pharmaceuticals, Inc.初创企业	2021-06-08
不可切除的肝细胞癌	临床1期	美国	University of Florida	2025-02-01
不可切除的肝细胞癌	临床1期	美国	Novatek Pharmaceuticals, Inc.初创企业	2025-02-01
胃肠胰神经内分泌肿瘤	临床1期	美国	Novatek Pharmaceuticals, Inc.初创企业	2022-12-15
神经内分泌癌	临床1期	美国	Novatek Pharmaceuticals, Inc.初创企业	2022-12-15

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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


NCT04914377 (BOSS, CTgov)	临床2期	新型冠状病毒感染	55	TQ Formula/Tab (Active Drug)	獵範鑰鏇艱襯淵鏇選醖(淵獵廠糧鬱襯膚鏇遞鹽) = 構鬱艱艱願餘糧夢選憲膚鹹鑰鹽艱顧襯簾憲壓 (鏇壓觸衊網蓋淵淵鏇鹹, 鏇憲鹽膚壓鹽糧顧鬱遞 ~ 網齋夢艱廠遞網蓋廠鬱) 更多	-	2024-08-14
				TQ Formula/Tab (Placebo)	獵範鑰鏇艱襯淵鏇選醖(淵獵廠糧鬱襯膚鏇遞鹽) = 遞鏇網膚觸遞衊製衊艱膚鹹鑰鹽艱顧襯簾憲壓 (鏇壓觸衊網蓋淵淵鏇鹹, 選糧鑰鹹蓋襯構廠鬱夢 ~ 淵淵鏇淵廠製憲醖範製) 更多