This clinical study will evaluate the safety and effectiveness of Gastrin treatment with islet transplantation to help patients with difficult to control type 1 diabetes make insulin again and improve blood sugar control.
This study involves two investigational (experimental) products not yet approved by the U.S. Food and Drug Administration (FDA) as a treatment for any disease:
Human allogenic islet cells (islet cells from a deceased, unrelated human donor)
Gastrin-17 (Gastrin) - a hormone secreted by the gut

Start Date07 Jul 2019

Sponsor / Collaborator

City of Hope National Medical Center

[+1]

NCT01909245 / Active, not recruitingPhase 2IIT

Islet Transplantation Using a T-Cell Depleting Immunosuppression Induction Regimen

City of Hope National Medical Center, located in Duarte, CA, is hosting a clinical study on islet cell transplantation, an experimental procedure being evaluated as a treatment for patients with type 1 diabetes. Islet cell transplantation involves taking insulin-producing cells from organ donors and transplanting them into the liver of a patient with diabetes. Once transplanted, the islets produce insulin, which can improve blood sugar control and eliminate the need to inject insulin or use an insulin pump.
Anti-thymocyte globulin (ATG) and alemtuzumab (Campath) are anti-rejection medications that work by decreasing a patient's T-cells. T-cells are special white blood cells that recognize and destroy unwanted things like infections but can also attack transplanted cells and organs. Reducing the number of T-cells at the time of transplant may protect islets and improve long-term transplant success. In previous research studies, islet transplantation has been successful in reducing low blood sugar episodes, improving overall blood sugar control, and in some cases, allowing patients with type 1 diabetes to stop taking insulin.
The purpose of this study is to determine if islet cell transplantation using ATG or alemtuzumab, along with additional medications to prevent the body from rejecting the transplanted cells, is a safe and effective treatment for type 1 diabetes. Study participants may receive up to three islet transplants and will be followed for five years to monitor blood sugar control, islet transplant function, and changes in quality of life.

Start Date16 Oct 2013

Sponsor / Collaborator

City of Hope National Medical Center

[+1]

NCT00020787 / CompletedPhase 3

An Open Label, Sequential Multi-Center Multi Dose Study Of G17T Immunogen In Combination With Cisplatin (CDDP) And 5-Fluorouracil (5-FU) In Subjects With Metastatic Or Locally Recurrent Gastric Or Gastroesophageal Cancer Previously Untreated With Chemotherapy For Advanced Disease (Stage IV)

RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining vaccine therapy with chemotherapy may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combining vaccine therapy and chemotherapy in treating patients who have metastatic or locally recurrent stomach cancer or esophageal cancer.

Start Date01 Jul 2001

Sponsor / Collaborator

Jonsson Comprehensive Cancer Center

100 Clinical Results associated with Polyclonal antibody stimulator(Aphton Corp.)

100 Translational Medicine associated with Polyclonal antibody stimulator(Aphton Corp.)

100 Patents (Medical) associated with Polyclonal antibody stimulator(Aphton Corp.)

2,712

Literatures (Medical) associated with Polyclonal antibody stimulator(Aphton Corp.)

01 Mar 2024·Journal of ethnopharmacology

The toxicokinetic and metabolism of structurally diverse pyrrolizidine alkaloids in rats

Article

Author: Yan, Xiaoyu ; He, Yisheng ; Lin, Ge ; Pan, Yueyang ; To, Yuen Ching

ETHNOPHARMACOLOGICAL RELEVANCE:

Pyrrolizidine alkaloids (PAs) are a group of phytotoxins present in about 3% of flowering plants worldwide. Ingestion of PA-containing herbal products may lead to hepatotoxicity. Notably, the toxicokinetic (TK) behaviors, especially pyrrole-protein adducts (PPAs) having the same structure but generated from metabolic activation of different PAs, significantly affect the toxicity of structurally diverse PAs, therefore studying them in their pure form is preferable to extracts to stratify toxic potency of different PAs co-existing in herbal extracts. However, previous studies mainly focus on the establishment of TK profiles of the intact PAs, revealing less or no kinetic information on the main PA metabolites (PA N-oxides) and PPAs which mediate PA-induced hepatotoxicity. In this study, PPA was measured as the biomarker of PA exposure and PA-induced toxicity.

AIM OF STUDY:

This study aims to investigate the TK difference between structurally diverse PAs of retronecine-type PAs: retrorsine (RTS) and monocrotaline (MCT), and otonecine-type PA: clivorine (CLI), and their toxicity-related metabolite PPAs and PA N-oxides, the main metabolite of retronecine-type PAs, for the establishment of a more accurate risk assessment of PAs exposure.

MATERIALS AND METHODS:

The TK studies were conducted using rats through intravenous (i.v.) or oral (p.o.) administration of PAs at 20 mg/kg. The main TK parameters of PAs and PA N-oxides were determined from plasma concentration-time profiles, and the kinetic profiles of PPAs were assessed from both plasma and erythrocyte concentration-time profiles.

RESULTS:

MCT demonstrated the slowest but the highest extent of absorption among the three PAs, while RTS demonstrated a similar absorption rate with a lower extent than CLI. For elimination, MCT demonstrated a similar elimination rate as RTS but the lowest extent of elimination among the three PAs, and CLI exhibited significantly faster elimination than MCT and RTS. Moreover, the formation of PA N-oxide, which only occurs in retronecine-type PAs, was remarkably less in MCT-treated rats compared to RTS-treated ones. Of note, the retronecine-type RTS and MCT induced more PPAs via p.o. than i.v. administration route, whereas the otonecine-type CLI showed the opposite trend.

CONCLUSION:

Dramatic TK differences, including not only PAs but also PA N-oxides and the derived protein adduct PPAs, were found among structurally diverse PAs in rats, laying the basis for varied hepatotoxic potencies induced by different PA-containing herbal products. Notably, our findings for the first time uncovered that oral administration of retronecine-type PAs might cause severer toxicity compared with the intravenous route, which warrants further in-depth exploration.

01 Mar 2024·Food chemistry

3D-printed solid phase microextraction fiber based on Co-Al layered double hydroxide nanosheets; application in determination of phenolic acids in fruit juice samples

Article

Author: Rezaei, Hadiseh ; Matin, Amir Abbas

3D printing technology has attracted great attention in various fields of science and technology. Application of this technology in manufacturing analytical tools is developing fast. High precision in manufacturing designed objects, fast production and low cost also green production approach by using biodegradable materials like polylactic acid is promising bright future in scientific researches. The development of new approaches in improving the functional groups of the surface of 3D printed objects in order to make 3D printed parts more functional with conventional 3D printed materials, causes the entry of many advanced materials in this field. In this study, a novel solid phase microextraction fiber was prepared based on Co-Al layered double hydroxide (LDH) nanosheets in-situ growth on 3D-printed aluminum-polylactic acid (PLA) composite and its application for determination of phenolic acids (PAs) including vanillic acid (VA), ferulic acid (FA), p-coumaric acid (p-CA), p-hydroxybenzoic acid (HBA), protocatechuic acid (PCA) and caffeic acid (CA) in fruit juice samples was investigated. The proposed fiber was prepared via a robust one-step hydrothermal synthesis of Co-Al LDH on an anodized 3D-printed Al-PLA fiber. Factors crucial for the extraction, including pH, extraction and desorption time and ionic strength were explored in detail. Under the optimal experimental conditions, for all PAs except PCA, LOD, LOQ and LDR were obtained as 0.03, 0.1 and 0.1-100.0 µgL^-1, respectively. For PCA, LOD, LOQ and LDR were obtained as 0.15, 0.50 and 0.5-100.0 µgL^-1, respectively.

02 Jan 2024·Food additives & contaminants. Part B, Surveillance

UHPLC-Q-TOF analysis of pyrrolizidine alkaloids in North-Macedonian honey

Article

Author: Cvetanoska, Marinela ; Petreska Stanoeva, Jasmina ; Pocrnić, Marijana ; Galić, Nives ; Stefova, Marina

Honey contaminated with pyrrolizidine alkaloids (PAs) could pose a risk for human consumption, being a widely consumed food product. A fast and simple LC/MS method for the analysis of pyrrolizidine alkaloids in honey was optimised to collect occurrence data. The extraction efficiency was evaluated by a systematic study of multiple solvent mixtures and clean-up procedures. The best results for PA extraction were obtained using a formic acid/methanol mixture with subsequent clean-up by the QuEChERS method, resulting in a mean recovery range of 91.8-102%. The method validation showed satisfactory intra-day (RSD < 5.1%) and inter-day precision (RSD < 9.1%). The proposed method was applied to 14 samples. A total of six PAs and two N-oxides were detected, with levels between 89 and 8188 µg/kg. This assessment highlights the potential risk of intoxication and the need for further investigations regarding an effective quality system for manufacturers to control PAs in honey.

News (Medical) associated with Polyclonal antibody stimulator(Aphton Corp.)

28 Feb 2023

·www.biospace.com

Cancer Advances, Inc. Announces Issuance of New U.S. Patent - February 28, 2023

DURHAM, N.C., Feb. 28, 2023 (GLOBE NEWSWIRE) -- Cancer Advances, Inc., a clinical stage biopharmaceutical company developing therapeutics for gastrointestinal (GI) cancers, announced that the U.S. Patent and Trademark Office has issued new patent No. 11,583,576, enhancing the Company’s intellectual property position for lead asset Polyclonal Antibody Stimulator (PAS) vaccine. The new patent titled “Compositions and Methods for Inducing Humoral and Cellular Immunities against Tumors and Cancer” covers a method for treating and/or preventing and/or inhibiting development of a tumor and/or a cancer associated with gastrin signaling in a subject. Gastrin mediated tumors include, but are not limited to, gastrointestinal cancers. The novel IP further covers methods for treatment of GI cancer by administering PAS followed by an immune checkpoint inhibitor. A related claim covers reduction in fibrosis associated with pancreatic cancer via the administration of this combination. “After more than six years of research, we are excited to have this patent issued. We have known that PAS can induce the development of antibodies to Gastrin, bringing Gastrin levels down and increasing survival times by 50% in GI clinical trials. With our research now demonstrating that PAS is able to alter the tumor microenvironment, it opens the door to many new opportunities to improve current treatment for GI cancer patients,” commented Lynda Sutton, President of Cancer Advances. The issued patent adds to the over one hundred granted global patents for PAS. Cancer Advances plans to seek approval for PAS in the treatment of gastric and pancreatic cancers. About Cancer Advances, Inc. Cancer Advances Inc. (Durham, NC) is a biotechnology company focused on impacting human health and preventing the progression of gastrointestinal cancers by enhancing the adaptive immune system. The company is led by an experienced management team with over one hundred and twenty years of combined experience in drug development and commercialization experience. About Polyclonal Antibody Stimulator (PAS) Polyclonal Antibody Stimulator (PAS) vaccine is an immunomodulator potentially applicable in multiple cancer types including gastric, pancreatic, and colorectal. The vaccine is a peptide-conjugate that includes an N-terminal epitope of human gastrin-17 (G17) linked to carrier diphtheria toxoid. PAS has been studied in multiple clinical trials, in over 1,500 human subjects, and has demonstrated an excellent safety and tolerability profile. Cancer Advances exclusively owns PAS and is funding and managing all aspects of the PAS gastrin vaccine program. Contact Cancer Advances, Inc. E-mail: jwingen@canceradvances.com

VaccineImmunotherapy

100 Deals associated with Polyclonal antibody stimulator(Aphton Corp.)

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KEGG	Wiki	ATC	Drug Bank
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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Stomach Cancer	Phase 3	US	Cancer Advances, Inc.	19 Jan 2009
Pancreatic Cancer	Phase 3	-	Cancer Advances, Inc.	14 Aug 2000
Gastroesophageal Reflux	Phase 2	US	Cancer Advances, Inc.	20 Jan 2009
Esophageal Carcinoma	Phase 2	-	Cancer Advances, Inc.	01 Aug 2000
Colorectal Cancer	Phase 2	-	Cancer Advances, Inc.	01 Apr 2000
Jaundice	Phase 2	-	Cancer Advances, Inc.	01 Aug 1999
Pancreatic Carcinoma	Phase 2	-	Cancer Advances, Inc.	01 Apr 1999
Adenocarcinoma of large intestine	Phase 2	GB	Cancer Advances, Inc.	01 Oct 1993
Metastatic Colorectal Carcinoma	Phase 2	GB	Cancer Advances, Inc.	01 Oct 1993

Clinical Result

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ASCO2006	Phase 3	Pancreatic Cancer	-	Gemcitabine + G17DT	chtvatxsrj(qnuzdgdgbd) = mayhkmzkly stfbmogddk (ohlmcicrsz )	-	20 Jun 2006
				Gemcitabine alone (placebo)	chtvatxsrj(qnuzdgdgbd) = mhnpzxpkaz stfbmogddk (ohlmcicrsz )
ASCO2004	Not Applicable	Pancreatic carcinoma non-resectable	154	G17DT	ygceatvjvy(deaxdwdxkc) = ohtrjwngzy texancdvgf (zurnkfddss )	Positive	15 Jul 2004
				Placebo	ygceatvjvy(deaxdwdxkc) = oyjtqgmjmm texancdvgf (zurnkfddss )

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