Open label, randomised, one period one sequence, single dose, pharmacokinetic study to evaluate the bioavailability of Resveratrol and Pterostilbene after administration of single dose of NOVAGENERE-XAR and NOVAGENERE-XAP capsules in six healthy, adult, male human subjects under fasting conditions

Start Date15 Jul 2022

Sponsor / Collaborator

Epigeneres Biotech Pvt Ltd.

JPRN-jRCTs031210153 / CompletedNot ApplicableIIT

A randomized, double-blind, controlled study of pterostilbene in aging infertile patients

Start Date16 Jun 2021

Sponsor / Collaborator-

NCT04841499 / CompletedNot ApplicableIIT

Effects of a Seven-day BASIS™ Supplementation on Menopausal Syndromes and Measurements of the Urinary Vitamin B3 and Estradiol Levels in Pre-, Peri- and Post-menopause

The purpose of this study is to determine whether a short supplementation (7days) with BASIS™ increases the natural production of estradiol, measured in urinary waste. The overall objective is to determine whether through increased estradiol levels, the undesirable menopausal effects, assessed via questionnaires, are mitigated by a short-term supplementation with BASIS™

Start Date05 Apr 2021

Sponsor / Collaborator

University of South Alabama

[+1]

100 Clinical Results associated with Pterostilbene

100 Translational Medicine associated with Pterostilbene

100 Patents (Medical) associated with Pterostilbene

826

Literatures (Medical) associated with Pterostilbene

31 Dec 2024·Journal of enzyme inhibition and medicinal chemistry

Design, synthesis, in vitro and in vivo biological evaluation of pterostilbene derivatives for anti-inflammation therapy

Article

Author: Cui, Quanren ; Li, Rong ; Wang, Ke ; Ruan, Banfeng ; Cao, Shiying ; Chen, Liuzeng ; Wang, Lifan ; Liu, Xiaohan ; Zou, Hui ; Zhou, Lingling ; Hu, Shuying

Pterostilbene (PST) is a naturally derived stilbene compound in grapes, blueberries, and other fruits. It is also a natural dietary compound with a wide range of biological activities such as antioxidant, anti-inflammatory, antitumor, and so on. Structural modifications based on the chemical scaffold of the pterostilbene skeleton are of great importance for drug discovery. In this study, pterostilbene skeletons were used to design novel anti-inflammatory compounds with high activity and low toxicity. A total of 30 new were found and synthesised, and their anti-inflammatory activity and safety were screened. Among them, compound E2 was the most active (against NO: IC₅₀ = 0.7 μM) than celecoxib. Further studies showed that compound E2 exerted anti-inflammatory activity by blocking LPS-induced NF-κB/MAPK signalling pathway activation. In vivo experiments revealed that compound E2 had a good alleviating effect on acute colitis in mice. In conclusion, compound E2 may be a promising anti-inflammatory lead compound.

09 Dec 2024·Critical reviews in food science and nutrition

Antiobesity pathways of pterostilbene and resveratrol: a comprehensive insight

Review

Author: Sanlier, Nevin ; Özyalçın, Büşra

It may not always be possible for obese individuals to limit energy intake or to provide and/or maintain greater energy expenditure through exercise and physical activity. Therefore, the search for effective methods for obesity continues. Recently, the anti-obesity effect of stilbenes has attracted attention. In this review, aim was evaluating the effect of pterostilbene and resveratrol against obesity and the possible mechanisms in this effect. Dietary phytochemicals can induce body weight loss by increasing basal metabolic rate and thermogenesis and/or altering lipid metabolism. Stilbenes are products of the plant phenylpropanoid pathway. Very important mechanisms for the anti-obesity impact belonging to resveratrol as well as pterostilbene include thermogenic activation in brown adipose tissue alongside the browning of white adipose tissue. Considering nutrition and dietary habits, which have an important place in lifestyle changes for both the prevention and the treatment of obesity, pterostilbene and resveratrol, which are polyphenols and stilbenes, are seen as promising. However, optimal dose, duration, mechanism, long-term safety, side effects, combination, elucidation of genomic interactions, and lifestyle modifications should be considered.

01 Dec 2024·JOURNAL OF NUTRITIONAL BIOCHEMISTRY

Ameliorative effect of phenolic compound-pterostilbene on corticosterone-induced hepatic lipid metabolic disorder in broilers

Article

Author: Wang, Shenao ; Yu, Hao ; Sun, Jing ; Wang, Yingjie ; Feng, Xingjun ; Zhang, Ruoshi

The aim of this study was to investigate the ameliorative effects of pterostilbene (PTE), a polyphenolic compound, on stress-induced lipid metabolic disorders in the liver of broiler chickens. Six hundred healthy, one-day-old Arbor Acres (AA) with similar weight were randomly assigned to five groups, each consisting of 8 replicates with 15 broilers per replicate. The groups included: a control group (fed a basal diet), and four groups treated with corticosterone (CORT) at varying dietary levels of PTE supplementation: CORT (0 mg/kg PTE), CORT-PT200 (200 mg/kg PTE), CORT-PT400 (400 mg/kg PTE), and CORT-PT600 (600 mg/kg PTE). The results indicated that PTE administration to corticosterone (CORT)-injected broilers significantly improved weight gain, reduced liver index, and lowered the elevation of serum AST, GGT, Glu, TC, TG, and LDL-c concentrations induced by CORT injection (P < 0.05), but had no significant effect on serum CORT concentration (P > 0.05). PTE also significantly reduced the increased rate of abdominal fat deposition induced by CORT, decreased the average size of adipocytes, and downregulated the expression of the FAS gene (P < 0.05). It reversed the increase in liver TC, TG, LDL-c, and NEFA content induced by CORT (P < 0.05). PTE had no significant effect on the expression of the glucocorticoid receptor GR (P > 0.05), but significantly upregulated the protein expression of Sirt1 and p-AMPK (P < 0.05), promoted the expression of lipid autophagy genes MAP1LC3B and lipolytic genes LPL, but inhibited the expression of fatty acid synthesis genes SREBP-1c, ACC, and SCD (P < 0.05). The addition of PTE to the diet alleviated CORT-induced oxidative stress and inflammation by enhancing T-SOD and GSH-Px activities, reducing MDA content, inhibiting p-NF-κB p65 and NLRP3 expression and the release of TNF-α and IL-1β in the serum, and increasing IL-4 content (P < 0.05). Overall, dietary PTE effectively regulates lipid metabolism and antioxidant status, offering a potential strategy to mitigate stress-induced metabolic disruptions in broilers.

News (Medical) associated with Pterostilbene

03 Jan 2024

·www.biospace.com

Therapeutic Solutions International Subsidiary Immunotherapy Company Res Nova Bio, Inc. Announces Positive Data on First Four Advanced Cancer Patients Treated with FloraStilbene™

Clinical Stage Oncology Biotech Leverages Active Ingredient in Abortion Pill to Induce Immunity to Cancer ELK CITY, Idaho--(BUSINESS WIRE)-- Therapeutic Solutions International, Inc. (TSOI), announced today that its Subsidiary Company Res Nova Biologics, successfully treated four advanced cancer patients with FloraStilbene™. The patients had no adverse events from drug administration and clinical signals of tumor response were observed. All patients have been followed-up with for more than three months. FloraStilbene™ is a drug comprising of a proprietary formulation of the abortion pill’s active ingredient (RU486) and pterostilbene. The drug is manufactured by Compounding Pharmacy Cure Stat1 and is available by prescription under Right To Try. Previously, the Company has demonstrated efficacy of FloraStilbene in stimulating immune responses in animal models of various cancers, with an emphasis on triple negative breast tumor models2. The use of pterostilbene for cancer immunotherapy was patented by Therapeutic Solutions International in 20173, subsequent to which, numerous independent groups have shown the ability of this compound to block prostate4, breast5, melanoma6, glioma7, and lung cancers8. “This is a major step forward in Res Nova’s development plan for FloraStilbene™. These data, combined with existing preclinical and animal studies will serve as the basis for future clinical trials which will provide the basis for FDA sales approval,” said Dr. James Veltmeyer, Chief Medical Officer and the Physician who administered the drug. “From an ethical perspective, we are proud to have the support of several major leaders of the Pro-Life Movement including Bishop Joseph L Coffey (of the Military Archdiocese)9 and Dr. George Delgado (Inventor of the Abortion Pill Reversal) who sit on the Company’s Advisory Board10.” “The brilliant founders of Res Nova, with a miraculous stroke of genius, are turning a drug that destroys life into a 'weapon' that destroys cancer to saves lives,” said Deacon Keith Esshaki, Member of the Company’s Advisory Board. “The rapid translation of FloraStilbene™ from a laboratory discovery to a compounded drug speaks volumes to the power of the team that Ms Ramos has assembled,” said Timothy Dixon, President and CEO of Therapeutic Solutions International. “Through leveraging relationships and resources provided by TSOI, we anticipate accelerated availability of FloraStilbene™ to the multitude of drug resistant cancer patients.” “Breast cancer is a major epidemic for which novel treatments and research directions are urgently needed. We are thankful to our colleagues but most importantly to the brave patients who participated in this study, which we anticipate will be the foundation for a paradigm shifting approach to this dreadful disease,” said Famela Ramos, President and CEO of Res Nova Bio, Inc. 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 Therapeutic Solutions International Spin-Off Res Nova Bio Partners with Cure Stat Rx to Manufacture First in Class Breast Cancer Immunotherapy Product FloraStilbene™ (yahoo.com) 2 Therapeutic Solutions International Subsidiary Res Nova Bio Inc Discovers New Mechanism of Action for Breast Cancer Immunotherapy Adjuvant FloraStilbene™ | BioSpace 3 US9682047B2 - Augmentation of oncology immunotherapies by pterostilbene containing compositions - Google Patents 4 Inhibition of miR-20a by pterostilbene facilitates prostate cancer cells killed by NK cells via up-regulation of NKG2D ligands and TGF-β1down-regulation: Heliyon 5 Differential Anticancer Activity of Pterostilbene Against Three Subtypes of Human Breast Cancer Cells | Anticancer Research (iiarjournals.org) 6 Pterostilbene supresses inflammation-induced melanoma metastasis by impeding neutrophil elastase-mediated thrombospondin-1 degradation – ScienceDirect 7 Pterostilbene promotes mitochondrial apoptosis and inhibits proliferation in glioma cells | Scientific Reports (nature.com) 8 Pterostilbene exerts anticancer activity on non-small-cell lung cancer via activating endoplasmic reticulum stress | Scientific Reports (nature.com) 9 Bishop Coffey - Archdiocese for the Military, USAArchdiocese for the Military, USA (milarch.org) 10 Res Nova Biologics Recruits Abortion Pill Reversal Founder to Scientific Advisory Board (yahoo.com)

Immunotherapy

20 Oct 2023

·www.biospace.com

Res Nova Biologics Announces First Cancer Patient Treated with FloraStilbene™

Therapeutic Solutions International Immuno-Oncology Subsidiary Makes Abortion Pill-Based Drug Available by Prescription through Cure Stat Rx Compounding Pharmacy ELK CITY, Idaho--(BUSINESS WIRE)-- Therapeutic Solutions International, Inc. (TSOI), announced today the successful first treatment of a patient with FloraStilbene™, a patent pending formulation of the abortion pill’s active ingredient, RU486, and pterostilbene. The Company has been utilizing pterostilbene, a naturally occurring analog of resveratrol, found in blueberries, for the treatment of cancer and immune modulation for several years, including being granted a patent on synergies with conventional immunotherapies1. In May of this year, Res Nova signed a collaborative agreement with compounding pharmacy Cure Stat Rx for developing a compounded formulation of FloraStilbene™2. “I have worked with Dr. Ramesh Chigurupati, President, and CEO of Cure Stat Rx for many years and have always been impressed by the efficiency and excellence in ability to provide compounded drugs and formulations,” said Dr. James Veltmeyer, Chief Medical Officer of Res Nova Bio. “We look forward to offering FloraStilbene™ to all patients taking immunotherapy, chemotherapy, or radiation therapy that can benefit from immune stimulation of NK cells, T cells, and dendritic cells.” FloraStilbene™ has previously been shown to enhance immunotherapy of various tumors3, as well as chemotherapy efficacy4. “The strategic objective of Therapeutic Solutions International is to develop intellectual property, use it to seed a subsidiary company, and let the subsidiaries grow and flourish,” stated Timothy Dixon, President, and CEO of Therapeutic Solutions International. “I am extremely proud of the leadership role of Ms. Ramos who in the period of less than a year was able to take FloraStilbene™ from concept to patient. This is literally unheard of in traditional biotechnology development models.” In addition to Res Nova, Therapeutic Solutions International has multiple subsidiaries including a) Campbell Neurosciences, focused on the identification of suicidal propensities using a proprietary test and various interventions5; b) Breath Biologics, which is in discussions with the FDA for its filed Phase I/II trial in COPD6; c) CTE Biologics, which is advancing its clinical stage technology for treating Chronic Traumatic Encephalopathy7; and d) VasoSome Vascular, which is in preclinical development of mesenchymal stem cell derived exosomes for treatment of aortic aneurysms8. “I am thankful for our translational medicine team that has worked closely with Drs Veltmeyer and Chigurupati for making this first patient treatment a reality,” said Famela Ramos, President, and CEO of Res Nova Bio. “Although we plan on performing clinical trials to formally establish a level of efficacy, we believe it is imperative to get this drug into the hands of physicians as soon as possible, and we are thankful for having the opportunity to do this today.” 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 US9682047B2 - Augmentation of oncology immunotherapies by pterostilbene containing compositions - Google Patents 2 Therapeutic Solutions International Spin-Off Res Nova Bio Partners with Cure Stat Rx to Manufacture First in Class Breast Cancer Immunotherapy Product FloraStilbene™ | Business Wire 3 Novel Mechanism of Action of FloraStilbene Suggests Potential for Enhancing Efficacy of Checkpoint Inhibitor, CAR-T Therapies (pharmacytimes.com) 4 FloraStilbene™ Demonstrates Synergy with Conventional Chemotherapy and Immunotherapy in Reducing Triple Negative Breast Cancer | BioSpace 5 Therapeutic Solutions International Spin-Off Campbell Neurosciences Provides Progress Update in Quest for Addressing Suicide as a Medical Condition | Business Wire 6 Spinoff Breathe Biologics to Lead TSOI's Stem Cell Therapy Research | COPD News Today 7 Therapeutic Solutions International Launches Subsidiary Company to Commercialize Clinical Data and IND for Treatment of Chronic Traumatic Encephalopathy (CTE) with JadiCell Universal Adult Stem Cells | Business Wire 8 Therapeutic Solutions Launches VasoSome Vascular Inc. to Commercialize Aortic Aneurysm Treatment - Endovascular Today (evtoday.com)

ImmunotherapyClinical Study

21 Aug 2023

·www.biospace.com

FloraStilbene™ Demonstrates Synergy with Conventional Chemotherapy and Immunotherapy in Reducing Triple Negative Breast Cancer

Res Nova Bio Reports Landmark Oncology Findings Supporting Clinical Translation of its Pterostilbene-Abortion Pill Cancer Adjuvant ELK CITY, Idaho--(BUSINESS WIRE)-- Therapeutic Solutions International, Inc. (TSOI) reported that its breast cancer immunotherapy spin-off company, Res Nova Bio, released data showing synergistic suppression of breast cancer growth when used in combination with anti-PD1 and anti-CTLA4 antibodies, which represent clinically used checkpoint inhibitors such as Keytruda and Yervoy, respectively. Additionally, the Company demonstrated that FloraStilbene™ administration increased efficacy of the standard chemotherapies Taxotere and Cytotoxan which are used in breast cancer. The data were filed in a patent application covering adjuvant use of FloraStilbene™ in radiotherapy, oncolytic virus therapy, adoptive cellular therapy, chimeric antigen receptor therapy, chemotherapy and immunotherapy. “I have witnessed first-hand the devastating suffering, both mental and physical, that patients with advanced breast cancer go through,” said Dr. James Veltmeyer, Chief Medical Officer of the Company. “The findings announced today are a major accomplishment in our development of non-toxic immunotherapies of breast cancer. By leveraging similarities between pregnancy and cancer we have successfully been able to turn the abortion pill, a drug associated with death, into something that potentially saves lives.” Studies have shown that the abortion pill reduces activity of the cytokine TGF-beta1,2, which is involved in protecting the fetus from the maternal immune response, as well as protecting cancer cells from immunity of the body3. At a cellular level immature dendritic cells, which are found in both cancer and pregnancy seem to be stimulated to maturation by treatment with the abortion pill4. “I congratulate Ms. Famela Ramos and her team who has already initiated treating advanced breast cancer patients with ValloVax and is now rapidly racing towards the clinic with FloraStilbene™,” said Timothy Dixon, President, and CEO of Therapeutic Solutions International. “The fact that Res Nova already has secured a manufacturing and distribution partner for FloraStilbene™, Cure Stat5 supports our hope of rapidly entering the clinic and perhaps even accelerated sales through a 505b2 mechanism.” “At Res Nova Bio we are fixated on providing hope for patients who currently have very limited hope,” said Famela Ramos, President, and CEO of Res Nova Bio. “Knowing the detailed mechanisms of action of our products ensures not only solid intellectual property protection but also respect and credibility of potential acquisition partners and regulators. I am thankful to our scientific team and collaborators for their unceasing dedication to patients and shareholders.” 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 Rearte et al. Mifepristone (RU486) restores humoral and T cell-mediated immune response in endotoxin immunosuppressed mice. Clin Exp Immunol. 2010 Dec; 162(3): 568–577. 2 Li et al. Mifepristone regulates Tregs function mediated by dendritic cells through suppressing the expression of TGF-β. Immunopharmacol Immunotoxicol . 2021 Feb;43(1):85-93. 3 Latifi et al. Dual role of TGF-β in early pregnancy: clues from tumor progression. Biol Reprod. 2019 Jun 1;100(6):1417-1430. 4 Xia et al. Dexamethasone enhances CTLA-4 expression during T cell activation. Cell Mol Life Sci. 1999 Sep;55(12):1649-56. 5 Therapeutic Solutions International Spin-Off Res Nova Bio Partners with Cure Stat Rx to Manufacture First in Class Breast Cancer Immunotherapy Product FloraStilbene™ | BioSpace

Immunotherapy

100 Deals associated with Pterostilbene

R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
Endometrioid intraepithelial neoplasia	Phase 2	US	National Cancer Institute	21 Jan 2019
Wounds and Injuries	Phase 1	US	Elysium Health, Inc.Startup	06 Dec 2018
Neurodegenerative Diseases	Preclinical	NL	APeT Holding B.V.	14 Mar 2022
Renal fibrosis	Preclinical	CN	West China Hospital	26 May 2017

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


KEYNOTE-048 (ASCO2018)	Not Applicable	Recurrent Squamous Cell Carcinoma of the Head and Neck	39	Pembrolizumab	grgjamcumx(cwezniarzu) = ugkysrymxw qbozgtgbrl (blvyblwqef ) View more	Positive	01 Jun 2018
				Cetuximab+Pt+5-FU (EXTREME)	grgjamcumx(cwezniarzu) = jjycbaqdrk qbozgtgbrl (blvyblwqef ) View more

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