Combination carboplatin and nab-paclitaxel as a first-line treatment for advanced thymic carcinoma
SummaryThymic carcinoma is a very rare neoplasm for which no optimal chemotherapeutic regimen has been established to date. Hence, we performed this study to investigate the efficacy and safety of carboplatin plus nanoparticle albumin-bound (nab)-paclitaxel as a first-line regimen for patients with advanced thymic carcinoma. We conducted this multi-institutional retrospective cohort study of patients with advanced thymic carcinoma who had received carboplatin plusnab-paclitaxel as a first-line chemotherapy between August 2013 and December 2021. Twelve patients were included in this study and were subjected to efficacy and ...
Source: Investigational New Drugs - January 12, 2023 Category: Drugs & Pharmacology Source Type: research
Modeling Approaches to Reimagine Stability (MARS) for Enabling Earlier Access to Critical Drugs for Patients with Unmet Medical Needs
In this study, a data mining exercise has been conducted with regulatory submissions of Investigational New Drug (IND) Applications, NDAs, and Abbreviated New Drug Applications (ANDAs) containing MARS data. The case studies presented herein demonstrate how MARS data has been applied to regulatory scenarios involving prediction of retest and/or shelf-life, bridging major development changes, and confirming that no degradation has been observed or predicted. Using the assumption of a linear time trend for those cases that do not display sufficient degradation to conduct MARS for projection of an expiration date, an analysis ...
Source: AAPS PharmSciTech - January 11, 2023 Category: Drugs & Pharmacology Authors: M Scott Furness Hong Cai Sithamalli Chandramouli Mariappan Chelliah Xiao Hong Chen Debasis Ghosh Shaobo Liu Sherita McLamore Ramnarayan Randad Meiyu Shen Source Type: research
Modeling Approaches to Reimagine Stability (MARS) for Enabling Earlier Access to Critical Drugs for Patients with Unmet Medical Needs
In this study, a data mining exercise has been conducted with regulatory submissions of Investigational New Drug (IND) Applications, NDAs, and Abbreviated New Drug Applications (ANDAs) containing MARS data. The case studies presented herein demonstrate how MARS data has been applied to regulatory scenarios involving prediction of retest and/or shelf-life, bridging major development changes, and confirming that no degradation has been observed or predicted. Using the assumption of a linear time trend for those cases that do not display sufficient degradation to conduct MARS for projection of an expiration date, an analysis ...
Source: AAPS PharmSciTech - January 11, 2023 Category: Drugs & Pharmacology Authors: M Scott Furness Hong Cai Sithamalli Chandramouli Mariappan Chelliah Xiao Hong Chen Debasis Ghosh Shaobo Liu Sherita McLamore Ramnarayan Randad Meiyu Shen Source Type: research
DGG-300273, a novel WNT/ β-catenin inhibitor, induces apoptotic cell death by activating ROS-BIM signaling in a Wnt-dependent manner in colon cancer cells
SummaryDysregulated Wnt signaling is associated with malignant oncogenic transformation, especially in colon cancer. Recently, numerous drugs have been developed based on tumorigenesis biomarkers, thus having high potential as drug targets. Likewise, WNT/ β-catenin pathway members are attractive therapeutic targets for colon cancer and are currently in various stages of development. However, although inhibitors of proteins regulating the WNT/β-catenin signaling pathway have been extensively studied, they have yet to be clinically approved, and the underlying molecular mechanism(s) of their anticancer effects remain poorl...
Source: Investigational New Drugs - December 20, 2022 Category: Drugs & Pharmacology Source Type: research
A phase 1 study of intravenous mitazalimab, a CD40 agonistic monoclonal antibody, in patients with advanced solid tumors
SummaryMitazalimab is an agonistic human monoclonal antibody targeting CD40, a target for anti-tumor immunotherapy. This phase 1, dose-escalation study evaluated the safety, dose-limiting toxicities (DLTs), pharmacokinetic and pharmacodynamic profile of mitazalimab. Adults with advanced solid malignancies received mitazalimab intravenously once every-2-weeks. Dose-escalation was pursued with and without pre-infusion corticosteroids for mitigation of infusion-related reactions (IRRs).
In all, 95 patients were enrolled in 7 cohorts (n = 50, 75–2000 µg/kg) with corticosteroids and in 5 cohorts (n = 45, 75–12...
Source: Investigational New Drugs - December 20, 2022 Category: Drugs & Pharmacology Source Type: research
Corrections to: Combination of TACE and Lenvatinib as a promising option for downstaging to surgery of initially unresectable intrahepatic cholangiocarcinoma
(Source: Investigational New Drugs)
Source: Investigational New Drugs - December 13, 2022 Category: Drugs & Pharmacology Source Type: research
Neoadjuvant toripalimab plus platinum-paclitaxel chemotherapy in stage II-III non-small cell lung cancer: a single-center, single-arm, phase I study in China
ConclusionNeoadjuvant toripalimab plus platinum-paclitaxel chemotherapy was tolerable and induced a pathological complete response in 55% of resectable NSCLC patients. (Source: Investigational New Drugs)
Source: Investigational New Drugs - December 12, 2022 Category: Drugs & Pharmacology Source Type: research
Ocular toxicity of investigational anti-cancer drugs in early phase clinical trials
This study reported the risks and timing of the ons et of a variety of ocular toxicities of anti-cancer drugs, which were fundamentally controllable. (Trial registration number. Retrospectively registered) (Source: Investigational New Drugs)
Source: Investigational New Drugs - December 5, 2022 Category: Drugs & Pharmacology Source Type: research
A prospective multicenter phase II study of FOLFIRINOX as a first-line treatment for patients with advanced and recurrent biliary tract cancer
This study defined primary endpoint might be met when the lower limit value of 80% confidence interval [CI] of the median PFS ≥ 6.0 months.
Between June 2016 and March 2020, 35 BTC patients (21 intrahepatic, 10 extrahepatic, 2 gallbladder, 2 ampulla) including 26 unresectable and 9 recurrent disease were enrolled. After a median follow-up of 13.9 months, the median PFS and OS were 7.4 (80% CI, 5.5–7.5) and 14.7 (80% CI, 11.8–15.7) months, respectively. Complete response was achieved in 1 (2.9%) and partial response in 10 (28.6%), giving an objective response rate of 31.4% and disease control rate of 74.3%. ...
Source: Investigational New Drugs - December 2, 2022 Category: Drugs & Pharmacology Source Type: research
Development of Fluorinated NP-59: A Revival of Cholesterol Use Imaging with PET
Conclusion: 18F-FNP-59 provided higher resolution images, with lower radiation dose to the subjects. It has the potential to provide a noninvasive test for patients with adrenocortical diseases. (Source: Journal of Nuclear Medicine)
Source: Journal of Nuclear Medicine - December 1, 2022 Category: Nuclear Medicine Authors: Brooks, A. F., Winton, W. P., Stauff, J., Arteaga, J., Henderson, B., Niedbala, J., Scott, P. J. H., Viglianti, B. L. Tags: Clinical Investigations Source Type: research
XiaoEr LianHuaQinqGan alleviates viral pneumonia in mice infected by influenza A and respiratory syncytial viruses
CONCLUSION: XELH efficacy partially depends on integrated immunoregulatory effects. XELH is a promising therapeutic option against childhood respiratory viral infections.PMID:36444944 | DOI:10.1080/13880209.2022.2147961 (Source: Pharmaceutical Biology)
Source: Pharmaceutical Biology - November 29, 2022 Category: Drugs & Pharmacology Authors: Wenyan Li Tongtong Li Chi Zhao Tao Song Yao Mi Zhang Chuangfeng Yunlong Hou Zhenhua Jia Source Type: research
New Perspectives on Antimicrobial Agents: Tecovirimat for Treatment of Human Monkeypox Virus
Antimicrob Agents Chemother. 2022 Nov 14:e0122622. doi: 10.1128/aac.01226-22. Online ahead of print.ABSTRACTTecovirimat is an antiviral drug initially developed against variola virus (VARV) to treat smallpox infection. Due to its mechanism of action, it has activity against the family of orthopoxviruses, including vaccinia and the human monkeypox virus (HMPXV). Efficacy studies have thus far been limited to animal models, with human safety trials showing no serious adverse events. Currently approved by the FDA only for the treatment of smallpox, tecovirimat shows promise for the treatment of HMPXV. Tecovirimat has been pre...
Source: Antimicrobial Agents and Chemotherapy - November 14, 2022 Category: Microbiology Authors: Clare E DeLaurentis Jennifer Kiser Jason Zucker Source Type: research
EGFR-TKI re-administration after osimertinib failure in T790M mutation loss cases with re-biopsy
SummaryData on the re-administration of epidermal growth factor receptor (EGFR)-tyrosine kinase inhibitors (TKIs) after osimertinib failure in patients with T790M-positive non –small cell lung cancer (NSCLC) is limited. EGFR-TKI re-administration efficacy may vary between patients with T790M loss and those with T790M persistent with re-biopsy after osimertinib treatment. Patients who received EGFR-TKI re-administration (gefitinib, erlotinib, afatinib, dacomitinib, and o simertinib) after osimertinib failure were identified from our database. T790M mutation status before EGFR-TKI re-administration was analyzed via repeat ...
Source: Investigational New Drugs - November 12, 2022 Category: Drugs & Pharmacology Source Type: research
Combination of ruxolitinib with ABT-737 exhibits synergistic effects in cells carrying concurrent JAK2V617F and ASXL1 mutations
In conclusion, we provide preclinical evidence showing that the combination of ruxolitinib and ABT-737 is a promising therapeutic strategy for MPN patients with concurrentJAK2V617F andASXL1 mutations. (Source: Investigational New Drugs)
Source: Investigational New Drugs - November 12, 2022 Category: Drugs & Pharmacology Source Type: research
