The purpose of the study is to (1) to determine the rate of PSA decline (the number declining). Tissue will be obtained for ancillary studies and (2) to determine the number of patients with a PSA decline to <1.0 ng/ml at 3 months in patients receiving Nexrutine® with standard radiation therapy. The Secondary Objective is to confirm the tolerability of this regimen. The Third Objective (Ancillary studies) is To evaluate the molecular response of Nexrutine®. Molecular response is defined as changes in the molecular pathways.

Start Date01 Jul 2011

Sponsor / Collaborator

University of Texas Health Science Center At San Antonio

100 Clinical Results associated with Phellodendron amurense bark extract

100 Translational Medicine associated with Phellodendron amurense bark extract

100 Patents (Medical) associated with Phellodendron amurense bark extract

Literatures (Medical) associated with Phellodendron amurense bark extract

01 Apr 2024·Molecular carcinogenesis

Corrigendum to “Nexrutine inhibits azoxymethane‐induced colonic aberrant crypt formation in rat colon and induced apoptotic cell death in colon adenocarcinoma cells”

01 Jan 2024·Immunity, inflammation and disease

Alleviating effect of Nexrutine on mucosal inflammation in mice with ulcerative colitis: Involvement of the RELA suppression

Article

Author: Xu, Hongyun ; Wu, Chunyu ; Wang, Danning ; Wang, Haiqiang

Abstract:

Background:

Nexrutine is an herbal extract derived from Phellodendron amurense, known for its anti‐inflammatory, antidiarrheal, and hemostatic properties. However, its effect on ulcerative colitis (UC) remains unclear.

Methods:

A mouse model of UC was induced by 3% dextran sulfate sodium, while human colonic epithelial cells NCM‐460 were exposed to lipopolysaccharide. Both models were treated with Nexrutine at 300 or 600 mg/kg, with Mesalazine applied as a positive control regimen. The disease activity index (DAI) of mice was calculated, and the pathological injury scores were assessed through hematoxylin and eosin staining. The viability of NCM‐460 cells was determined using the CCK‐8 method. Inflammatory cytokines were detected using ELISA kits. Expression of mucin 3 (MUC3), Claudin‐1, and tight junction protein (ZO‐1) was detected to analyze mucosal barrier integrity. Target genes of Nexrutine were predicted using bioinformatics tools. Expression of RELA proto‐oncogene (RELA) was analyzed using qPCR and western blot assays.

Results:

The Nexrutine treatments significantly alleviated DAI of mice, mitigated pathological changes in their colon tissues, decreased the production of pro‐inflammatory cytokines, enhanced the barrier integrity‐related proteins, and increased NCM‐460 cell viability in vitro. RELA, identified as a target gene of Nexrutine, showed elevated levels in UC models but was substantially suppressed by Nexrutine treatment. Adenovirus‐mediated RELA upregulation in mice or the overexpression plasmid of RELA in cells counteracted the effects of Nexrutine treatments, exacerbating UC‐related symptoms.

Conclusion:

This study demonstrates that Nexrutine alleviates inflammatory mucosal barrier damage in UC by suppressing RELA transcription.

01 Jul 2021·Heliyon

Safety studies of Nexrutine, bark extract of Phellodendron amurense through repeated oral exposure to rats for 28 days

Article

Author: Jagdale, Pankaj Ramji ; Alam, Shamshad ; Ansari, Kausar Mahmood ; Ayanur, Anjaneya ; Mandal, Payal

Nexrutine (NX), a marketable herbal extract from a traditional Chinese herbal plant, Phellodendron amurense, is majorly used for the resolution of inflammation, gastroenteritis, and some tissue-specific cancer. Strategies for the identification of the safety of anticancer solutions of plant origin are an important area of study. The present investigation assesses the single and repeated dose (28 days) toxicity of NX following OECD guidelines 425 and 407, respectively. Briefly, to identify acute toxic properties of NX, a dose of 2000 mg/kg b. wt was administered once orally. Simultaneously, repeated dose toxicity was evaluated through daily administration of the three different doses (250, 500, 750 mg/kg b. wt) of NX for 28days. The single administration of NX showed no signs of toxicity and morbidity, suggesting LD50 of NX more than 2000 mg/kg b. wt. Furthermore, repeated dose exposure of NX for 28 days did not show any sign of toxicity. Hematology, serum biochemistry, and histopathological analysis also did not show any significant abnormalities. However, a marginal decrease in triglyceride, cholesterol, and glucose levels along with mild tubular degeneration in the kidney was also noticed in the high dose NX treatment group. Overall, the findings of the study suggest that NX is safe for use up to 500 mg/kg b.wt.

News (Medical) associated with Phellodendron amurense bark extract

02 Jan 2024

·www.prnewswire.com

Hi-Tech Pharmaceuticals Launches SLIMAGLUTIDE® for Weight Management and Blood Sugar Metabolism Support

NORCROSS, Ga., Jan. 2, 2024 /PRNewswire/ -- Hi-Tech Pharmaceuticals, a leading manufacturer of cutting-edge dietary supplements and weight management supplements, is proud to announce the launch of its latest product, SLIMAGLUTIDE®. This groundbreaking supplement provides a natural and effective solution for blood sugar metabolism support and healthy weight management.* Slimaglutide® is a groundbreaking weight management supplement utilizing 10 Glucagon-like Peptide-1 (GLP-1) Receptor agonist and secretagogues to provide a natural and effective solution for blood sugar metabolism support, healthy weight management and at an affordable cost.* Hi-Tech's Research and Development Team spent over a year researching the active ingredients and compounds that make Slimaglutide®. This Novel and Revolutionary weight management aid will turn the Diet Industry on its head! Hi-Tech Pharmaceuticals is a leader in phellodendron and berberine research with its Nexrutine® series of berberine extracts, which have over two decades of studies and real world results in many of Hi-Tech's branded products. Slimaglutide® utilizes a 97% pure Nexrutine®XS extract naturally derived from phellodendron bark. Hi-Tech launch of Slimaglutide® benefits from Hi-Tech being the forefront of Berberine research with its Nexrutine product. The berberine utilized in Slimaglutide® utilized a Berberine Pharmacokinetic study that showed improved berberine bioavailability (AUC) by over 10 times on molar basis and with observed dose linearity. Our berberine increased retention time from about 30-45 minutes to over 10 hours! The uniqueness of Nexrutine XS® Berberine derives directly from one of berberine's main limits: bioavailability. The raw extract has extremely poor oral bioavailability and bioabsorption profile. Nexrutine XS® Berberine groundbreaking supplement harnesses the power of berberine to provide a natural and effective solution for blood sugar metabolism support and healthy weight management. Slimaglutide® effectively support metabolic health, favorably modulating insulin response; improving the blood sugar profile, leveling both blood glycemic and insulin; having a positive effect on body composition and inducing the redistribution of adipose tissue. Hi-Tech's utilizes our proprietary Cyclosome®, a special structure of sunflower lecithin and cyclodextrin that ensures your body can absorb the plant extracts as they pass through your body. For Slimaglutide® we also incorporate sodium caprate (C10, a medium-chain triglyceride) to promote optimal absorption and maintenance of gastrointestinal comfort during berberine supplementation. As a society, our expanding waistlines have only increased our pre-existing concerns regarding our blood sugar and cholesterol levels. Slimaglutide® provides an effective, natural means of supporting our efforts toward more balanced blood sugar and weight management. The second pathway Hi-Tech researchers found effective compounds are from glucose-dependent Insulinotropic polypeptide (GIP). Hi-Tech developed a proprietary extract called TwinCretin® from the Fagonia Cretia, which stimulated both GLP-1 and GIP secretion, increased cellular hormone content, and upregulated gene expression of proglucagon, GIP and prohormone convertase. The release of GLP-1 and related effects delay gastric emptying and bowel motility, and in addition, exerts pressure on the hypothalamus to alter satiety; thereby, reducing appetite and assisting in weight management. Slimaglutide® is the only omni-faceted nutraceutical on the market to attack both GLP-1 and GIP secretion and is extremely potent when it comes to weight management. "Hi-Tech is often first to market with cutting-edge products, and Slimaglutide® may be our crown jewel," said Jared Wheat, President and CEO of Hi-Tech. "With the launch of Slimaglutide®, consumers can experience the remarkable weight management benefits of GLP-1 receptor agonists and the power of a one-of-a kind- GIP nutraceutical." *These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent disease. Media Contact: Brandon Schopp [email protected] 770-797-9959 SOURCE Hi-Tech Pharmaceuticals, Inc.

Drug Approval

28 Dec 2023

·www.prnewswire.com

Hi-Tech Pharmaceuticals Introduces SLIMAGLUTIDE® - A Revolutionary Breakthrough in Weight Management and Glucagon-like Peptide-1 (GLP-1) Receptor Agonist

NORCROSS, Ga., Dec. 28, 2023 /PRNewswire/ -- Hi-Tech Pharmaceuticals, a leading manufacturer of cutting-edge dietary supplements and weight management supplements, is proud to announce the launch of its latest product, SLIMAGLUTIDE®. This groundbreaking supplement provides a natural and effective solution for blood sugar metabolism support and healthy weight management.* Slimaglutide® is a groundbreaking weight management supplement utilizing berberine along with 10 other Glucagon-like Peptide-1 (GLP-1) Receptor agonist and secretagogues to provide a natural and effective solution for blood sugar metabolism support, healthy weight management and at an affordable cost.* Hi-Tech's Research and Development Team spent over a year researching the active ingredients and compounds that make Slimaglutide®, a Novel and Revolutionary weight management aid that will help millions of people feel great! Hi-Tech Pharmaceuticals is a leader in phellodendron and berberine research with its Nexrutine® series of berberine extracts, which have over two decades of studies and real world results in many of Hi-Tech's branded products. Slimaglutide® utilizes a 97% pure Nexrutine®XS extract naturally derived from phellodendron bark. Slimaglutide® also uses a high grade extract called YGDPure® that has been shown to work via the GLP-1 pathway among other pathways, and in multiple clinical trials has been shown in a 45 day trial that those taking YGD had incredible results! This is just another of the amazing GLP-1 compounds found in Slimaglutide®. Consumer interest in berberine, an herbal compound extracted from various plants, has skyrocketed in popularity in the past few weeks due to increased chatter over social media platforms, such as TikTok. Hi-Tech's Nexrutine® is the most studied berberine extract used for a variety of health related issues. Berberine has been used for centuries in traditional herbalism and ayurvedic medicine; however, berberine is notoriously difficult for the body to absorb effectively and often does not yield the desired results. Hi-Tech utilizes a proprietary and clinically-studied form of berberine called Nexrutine® XS Cyclosome®, which applies cutting-edge, ultra-absorption liposome and cyclodextrin technologies to address these challenges. The second pathway Hi-Tech researchers found effective compounds are from glucose-dependent Insulinotropic polypeptide (GIP). Hi-Tech developed a proprietary extract called TwinCretin® from the Fagonia Cretia, which stimulated both GLP-1 and GIP secretion, increased cellular hormone content, and upregulated gene expression of proglucagon, GIP and prohormone convertase. The release of GLP-1 and related effects delay gastric emptying and bowel motility, and in addition, exerts pressure on the hypothalamus to alter satiety; thereby, reducing appetite and assisting in weight management. Slimaglutide® is the only omni-faceted nutraceutical on the market to attack both GLP-1 and GIP secretion and is extremely potent when it comes to weight management. "Hi-Tech is committed to delivering products found in Nature and Backed by Science®," said Jared Wheat, President and CEO of Hi-Tech. "With the launch of Slimaglutide®, consumers can experience the remarkable weight management benefits of GLP-1 receptor agonists and the power of a one-of-a kind- GIP nutraceutical." About Hi-Tech: Hi-Tech Pharmaceuticals is an enormously successful company that creates, manufactures and sells high-quality products. Hi-Tech has been able to increase its market share in the United States through the acquisition of sixteen acquisitions in recent years, which included the manufacturing bases of Synergy Nutritional Industries in 2005 and Nittany Pharmaceuticals in Pennsylvania in 2012. Hi Tech also acquired many large brands such as: APS Nutrition, ALR, FormuTech Nutrition, Sports One, Innovative Laboratories, LG Sciences, iForce Nutrition, Prime Nutrition, Top Secret Nutrition, EAS and BPI Sports. Hi-Tech's recent strategy has been, and according to its leaders will continue to be, growth through Merger and Acquisition activity. *These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent disease. Media Contact: Brandon Schopp, (770) 797-9959, 370516@email4pr.com SOURCE Hi-Tech Pharmaceuticals

AcquisitionClinical Result

100 Deals associated with Phellodendron amurense bark extract

R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
Prostatic Cancer	Phase 2	United States	University of Texas Health Science Center At San Antonio	01 Jul 2011
Colitis, Ulcerative	Preclinical	China	Heilongjiang University of Chinese Medicine	19 Jan 2024

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT01705652 (Nexrutine, CTgov)	Phase 2	Prostatic Cancer	21	Nexrutine (Nexrutine Surgery Group)	huefpdhjkj(lpfqthhzfp) = harmxwwsau jxkjcifnbg (atdxzotulj, hhycwclmou - zxwnccrfum) View more	-	11 Jun 2015
				Nexrutine (Nexrutine Radiation Group)	huefpdhjkj(lpfqthhzfp) = bxlapdrzgo jxkjcifnbg (atdxzotulj, nkhxpxurhq - afhhsneurd) View more

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