Fecal Microbiota Transplantation: History, Procedure and Regulatory Considerations
Presse Med. 2023 Nov 7:104204. doi: 10.1016/j.lpm.2023.104204. Online ahead of print.ABSTRACTFecal microbiota transplantation (FMT) is a medical treatment which involves the transfer of feces from a healthy donor to a recipient to restore the balance of gut microbiota and improve clinical outcomes. FMT has gained recognition in recent years due to its effectiveness in treating recurrent Clostridioides difficile infections (rCDI) and other gastrointestinal disorders. Additionally, it has been studied as an intervention for some other conditions, like inflammatory bowel disease (IBD) and irritable bowel syndrome (IBS). This ...
Source: Presse Medicale - November 9, 2023 Category: General Medicine Authors: Thanush D M P Venkatesh Source Type: research
Fecal Microbiota Transplantation: History, Procedure and Regulatory Considerations
Presse Med. 2023 Nov 7:104204. doi: 10.1016/j.lpm.2023.104204. Online ahead of print.ABSTRACTFecal microbiota transplantation (FMT) is a medical treatment which involves the transfer of feces from a healthy donor to a recipient to restore the balance of gut microbiota and improve clinical outcomes. FMT has gained recognition in recent years due to its effectiveness in treating recurrent Clostridioides difficile infections (rCDI) and other gastrointestinal disorders. Additionally, it has been studied as an intervention for some other conditions, like inflammatory bowel disease (IBD) and irritable bowel syndrome (IBS). This ...
Source: Presse Medicale - November 9, 2023 Category: General Medicine Authors: Thanush D M P Venkatesh Source Type: research
Fecal Microbiota Transplantation: History, Procedure and Regulatory Considerations
Presse Med. 2023 Nov 7:104204. doi: 10.1016/j.lpm.2023.104204. Online ahead of print.ABSTRACTFecal microbiota transplantation (FMT) is a medical treatment which involves the transfer of feces from a healthy donor to a recipient to restore the balance of gut microbiota and improve clinical outcomes. FMT has gained recognition in recent years due to its effectiveness in treating recurrent Clostridioides difficile infections (rCDI) and other gastrointestinal disorders. Additionally, it has been studied as an intervention for some other conditions, like inflammatory bowel disease (IBD) and irritable bowel syndrome (IBS). This ...
Source: Presse Medicale - November 9, 2023 Category: General Medicine Authors: Thanush D M P Venkatesh Source Type: research
Fecal Microbiota Transplantation: History, Procedure and Regulatory Considerations
Presse Med. 2023 Nov 7:104204. doi: 10.1016/j.lpm.2023.104204. Online ahead of print.ABSTRACTFecal microbiota transplantation (FMT) is a medical treatment which involves the transfer of feces from a healthy donor to a recipient to restore the balance of gut microbiota and improve clinical outcomes. FMT has gained recognition in recent years due to its effectiveness in treating recurrent Clostridioides difficile infections (rCDI) and other gastrointestinal disorders. Additionally, it has been studied as an intervention for some other conditions, like inflammatory bowel disease (IBD) and irritable bowel syndrome (IBS). This ...
Source: Presse Medicale - November 9, 2023 Category: General Medicine Authors: Thanush D M P Venkatesh Source Type: research
The ATR inhibitor berzosertib acts as a radio- and chemosensitizer in head and neck squamous cell carcinoma cell lines
AbstractAlterations in the DNA damage response play a crucial role in radio- and chemoresistance of neoplastic cells. Activation of the Ataxia telangiectasia and Rad3-related (ATR) pathway is an important DNA damage response mechanism in head and neck squamous cell carcinoma (HNSCC). Berzosertib, a selective ATR inhibitor, shows promising radio- and chemosensitizing effects in preclinical studies and is well tolerated in clinical studies. The aim of this study was to elucidate the effect of berzosertib treatment in combination with radiation and cisplatin in HNSCC. The HNSCC cell lines Cal-27 and FaDu were treated with ber...
Source: Investigational New Drugs - November 7, 2023 Category: Drugs & Pharmacology Source Type: research
Prostate-Specific Membrane Antigen-Targeting Alpha Emitter via Antibody Delivery for Metastatic Castration-Resistant Prostate Cancer: A Phase I Dose-Escalation Study of < sup > 225 < /sup > Ac-J591
CONCLUSION: To our knowledge, this is the first-in-human phase I dose-escalation trial of a single dose of 225Ac-J591 in 32 patients with pretreated progressive mCRPC demonstrated safety and preliminary efficacy signals. Further investigation is underway.PMID:37922438 | DOI:10.1200/JCO.23.00573 (Source: Clinical Prostate Cancer)
Source: Clinical Prostate Cancer - November 3, 2023 Category: Cancer & Oncology Authors: Scott T Tagawa Charlene Thomas A Oliver Sartor Michael Sun Judith Stangl-Kremser Mahelia Bissassar Shankar Vallabhajosula Sandra Huicochea Castellanos Jones T Nauseef Cora N Sternberg Ana Molina Karla Ballman David M Nanus Joseph Osborne Neil H Bander Source Type: research
Prostate-Specific Membrane Antigen-Targeting Alpha Emitter via Antibody Delivery for Metastatic Castration-Resistant Prostate Cancer: A Phase I Dose-Escalation Study of < sup > 225 < /sup > Ac-J591
CONCLUSION: To our knowledge, this is the first-in-human phase I dose-escalation trial of a single dose of 225Ac-J591 in 32 patients with pretreated progressive mCRPC demonstrated safety and preliminary efficacy signals. Further investigation is underway.PMID:37922438 | DOI:10.1200/JCO.23.00573 (Source: Cancer Control)
Source: Cancer Control - November 3, 2023 Category: Cancer & Oncology Authors: Scott T Tagawa Charlene Thomas A Oliver Sartor Michael Sun Judith Stangl-Kremser Mahelia Bissassar Shankar Vallabhajosula Sandra Huicochea Castellanos Jones T Nauseef Cora N Sternberg Ana Molina Karla Ballman David M Nanus Joseph Osborne Neil H Bander Source Type: research
Prostate-Specific Membrane Antigen-Targeting Alpha Emitter via Antibody Delivery for Metastatic Castration-Resistant Prostate Cancer: A Phase I Dose-Escalation Study of < sup > 225 < /sup > Ac-J591
CONCLUSION: To our knowledge, this is the first-in-human phase I dose-escalation trial of a single dose of 225Ac-J591 in 32 patients with pretreated progressive mCRPC demonstrated safety and preliminary efficacy signals. Further investigation is underway.PMID:37922438 | DOI:10.1200/JCO.23.00573 (Source: Clinical Prostate Cancer)
Source: Clinical Prostate Cancer - November 3, 2023 Category: Cancer & Oncology Authors: Scott T Tagawa Charlene Thomas A Oliver Sartor Michael Sun Judith Stangl-Kremser Mahelia Bissassar Shankar Vallabhajosula Sandra Huicochea Castellanos Jones T Nauseef Cora N Sternberg Ana Molina Karla Ballman David M Nanus Joseph Osborne Neil H Bander Source Type: research
Targeted degradation of SNCA/ α-synuclein aggregates in neurodegeneration using the AUTOTAC chemical platform
In this study, we employed AUTOTAC to synthesize ATC161, a chimeric compound that adopts Anle138b as target-binding ligand (TBL) for SNCA aggregates. The autophagy-targeting ligand (ATL) of ATC161 was designed to allosterically activate the autophagy receptor SQSTSM1/p62 (sequestosome 1), a key step for targeting SNCA aggregates to the phagophore. The lysosomal degradation of SNCA aggregates by ATC161 acutely occurs at DC50 of 100-500 nM with no significant off-target degradation of monomeric SNCA. ATC161 protects cells from DNA and mitochondrial damage by SNCA aggregates. In PD model mice, oral administration of ATC161 de...
Source: Autophagy - November 2, 2023 Category: Cytology Authors: Jihoon Lee Dabin Yoon Ki Woon Sung Eun-Jin Bae Da-Ha Park Young Ho Suh Yong Tae Kwon Source Type: research
Targeted degradation of SNCA/ α-synuclein aggregates in neurodegeneration using the AUTOTAC chemical platform
In this study, we employed AUTOTAC to synthesize ATC161, a chimeric compound that adopts Anle138b as target-binding ligand (TBL) for SNCA aggregates. The autophagy-targeting ligand (ATL) of ATC161 was designed to allosterically activate the autophagy receptor SQSTSM1/p62 (sequestosome 1), a key step for targeting SNCA aggregates to the phagophore. The lysosomal degradation of SNCA aggregates by ATC161 acutely occurs at DC50 of 100-500 nM with no significant off-target degradation of monomeric SNCA. ATC161 protects cells from DNA and mitochondrial damage by SNCA aggregates. In PD model mice, oral administration of ATC161 de...
Source: Autophagy - November 2, 2023 Category: Cytology Authors: Jihoon Lee Dabin Yoon Ki Woon Sung Eun-Jin Bae Da-Ha Park Young Ho Suh Yong Tae Kwon Source Type: research
FDA Accepts NDA for Investigational RA Agent
In August, the U.S. Food & Drug Administration (FDA) accepted an investigational new drug application for MYMD-1, an oral tumor necrosis factor (TNF) α inhibitor that crosses the blood-brain barrier. Currently in pre-clinical studies, MYMD-1 is designed to regulate the immune system by selectively blocking TNF-α when it becomes overactivated during a cytokine storm and... (Source: The Rheumatologist)
Source: The Rheumatologist - November 1, 2023 Category: Rheumatology Authors: Natasha Yetman Tags: Biologics/DMARDs Drug Updates tumor necrosis factor (TNF) inhibitors U.S. Food and Drug Administration (FDA) Source Type: research
Clinical characteristics and prognostic impact of immune checkpoint inhibitor-associated myocarditis in advanced non-small cell lung cancer
This study designed to explore the associations between cardiac parameters and outcomes of myocarditis in advanced non-small cell lung cancer (NSCLC) who treated with immune checkpoint inhibitor (ICI). Fourteen patients diagnosed with ICI-associated myocarditis by clinicians were admitted to the study analysis. By Cox univariate and multivariate survival analyses, potential risk factors for the development of severe myocarditis were identified. Survival analysis was also performed to explore the prognosis of patients with myocarditis. Among patients with myocarditis, higher B-type natriuretic peptide (BNP) levels (P = 0....
Source: Investigational New Drugs - October 30, 2023 Category: Drugs & Pharmacology Source Type: research
Clinical characteristics, treatment, and management of pembrolizumab induced hemophagocytic lymphohistiocytosis
ConclusionHLH should be suspected when unexplained fever, cytopenia, splenomegaly, and elevated aminotransferase occur in patients using pembrolizumab. Screening for risk factors before treatment with pembrolizumab may be necessary to prevent HLH. (Source: Investigational New Drugs)
Source: Investigational New Drugs - October 28, 2023 Category: Drugs & Pharmacology Source Type: research
Pharmacokinetics, pharmacodynamics and efficacy of pemigatinib (a selective inhibitor of fibroblast growth factor receptor 1 –3) monotherapy in Chinese patients with advanced solid tumors: a phase i clinical trial
AbstractPemigatinib is a selective fibroblast growth factor receptor (FGFR)1 –3 inhibitor and has demonstrated acceptable tolerability and clinical activity in advanced solid tumors in Western population. This phase I trial evaluated pharmacokinetics/pharmacodynamics (PK/PD) characteristics, preliminary safety and efficacy of pemigatinib in Chinese patients with advanced, solid tumors. Patients with unresectable advanced or metastatic solid tumors bearing FGF/FGFR1-3 alterations received oral pemigatinib at 13.5 mg once daily (QD) on a 2-weeks-on/1-week-off schedule. The primary endpoint was PK/PD characteristics; secon...
Source: Investigational New Drugs - October 27, 2023 Category: Drugs & Pharmacology Source Type: research
Preclinical studies supporting a first-in-human trial of pulmonary macrophage transplantation therapy of CSF2RA-associaited PAP
CSF2RA mutations cause hereditary pulmonary alveolar proteinosis (hPAP), a disorder of alveolar macrophage dysfunction, surfactant accumulation, and hypoxemic respiratory failure, and, in some patients, serious infections or pulmonary fibrosis - without an approved disease-specific therapy. After reporting hPAP in 2008, we developed diagnostics, identified a patient cohort, and defined its pathogenesis, presentation, and natural history. We discovered that lentiviral-mediated CSF2RA gene transfer restored GM-CSF signaling in hPAP patient macrophages. We developed and validated Csf2raKO mice as a model o...
Source: European Respiratory Journal - October 27, 2023 Category: Respiratory Medicine Authors: Arumugam, P., Carey, B., Trump-Durbin, L., Wessendarp, M., Suzuki, T., Spoorthi, F., Ma, Y., Shima, K., Stock, J., Chalk, C., Wikenheiser-Brokamp, K., Lutzko, C., Trapnell, B. Tags: Rare ILD/DPLD Source Type: research
