Leukotriene B4 receptor 2 correlates with prognosis and immune infiltration in clear cell renal cell carcinoma
Conclusion. BLT2 may serve as a novel prognostic biomarker and is related to the shaping of tumor immune microenvironment in ccRCC. The expression of BLT2 potentially contributes to the regulation of TAMs, T cell exhaustion, and Tregs activation in ccRCC, providing new approaches to promote the development of new immunotherapeutic strategies for ccRCC. (Source: Investigational New Drugs)
Source: Investigational New Drugs - October 11, 2021 Category: Drugs & Pharmacology Source Type: research

Efficacy and safety of mitoxantrone hydrochloride liposome injection in Chinese patients with advanced breast cancer: a randomized, open-label, active-controlled, single-center, phase II clinical trial
Conclusions The clinical benefit parameters of Lipo-MIT and MIT were comparable. Lipo-MIT provided a different toxicity profile, which might be associated with the altered distribution of the drug. Additional study is needed to elucidate the potential benefit of Lipo-MIT in ABC.Clinical trial registration. This study is registered with ClinicalTrials.gov (No. NCT02596373) on Nov 4, 2015. (Source: Investigational New Drugs)
Source: Investigational New Drugs - October 11, 2021 Category: Drugs & Pharmacology Source Type: research

Zerumbone acts as a radiosensitizer in head and neck squamous cell carcinoma
Conclusion. The natural compound zerumbone shows a cytotoxic and proapoptotic effect on HNSCC cell lines. Furthermore, zerumbone enhances the radiation effect in all three cell lines and thus may be a suitable candidate for combination therapy in HNSCC. (Source: Investigational New Drugs)
Source: Investigational New Drugs - October 6, 2021 Category: Drugs & Pharmacology Source Type: research

Phase Ia dose escalation study of OBP-801, a cyclic depsipeptide class I histone deacetylase inhibitor, in patients with advanced solid tumors
Conclusion Further investigations of the OBP-801 1.0  mg/m2 dose will be needed to better understand the efficacy of the agent, either alone or in combination.Trial registration: NCT02414516 (ClinicalTrials.gov) registered on April 10, 2015. (Source: Investigational New Drugs)
Source: Investigational New Drugs - October 6, 2021 Category: Drugs & Pharmacology Source Type: research

Combined immunotherapy and targeted treatment for primary alveolar soft part sarcoma of the lung: case report and literature review
We report herein a unique case of primary alveolar soft part sarcoma of the lung. The patient was a 24-year-old man with metastases to multiple organs, such as the brain, lungs, pancreas, and liver. The craniocerebral lesions attained partial remission after whole-brain radiotherapy and targeted combined immunotherapy, and other distant metastases completely disappeared after targeted combined immunotherapy (anlotinib and camrelizumab), indicating significant treatment efficacy. Anlotinib is an oral multi-target tyrosine kinase inhibitor (TKI) that exerts its anti-tumor effects by acting on various kinases. Camrelizumab is...
Source: Investigational New Drugs - September 9, 2021 Category: Drugs & Pharmacology Source Type: research

Pembrolizumab for advanced penile cancer: a case series from a phase II basket trial
Conclusion: In sum, single-agent pembrolizumab was well tolerated as salvage therapy in a small cohort of patients with unresectable, locally advanced or metastatic penile SCC. Pembrolizumab produced an objective response in an MSI-H tumor, yet it did not control disease in two patients with MSS penile SCC. Rationale combination therapies, including pembrolizumab, warrant further investigation.Trial registration: ClinicalTrials.gov identifier:NCT02721732. Registered March 23, 2016. (Source: Investigational New Drugs)
Source: Investigational New Drugs - September 9, 2021 Category: Drugs & Pharmacology Source Type: research

The drug lag issue: a 20-year review of China
SummaryChina has been criticized for the long drug delay for a long time. There was little understanding of Chinese drug lag formation from the investigational new drug (IND) submission to the new drug application (NDA) approval. Therefore, we analyzed the problem of drug lag in China cumulating from the clinical trial starting lag to the lags formed during the regulatory process and discerned the key underlying factors. After investigating the availability in China of new molecular entities (NMEs) approved by the Food and Drug Administration (FDA) between 1999 and 2019, we find that even though cutting regulatory process ...
Source: Investigational New Drugs - September 9, 2021 Category: Drugs & Pharmacology Source Type: research

Vorolanib (X-82), an oral anti-VEGFR/PDGFR/CSF1R tyrosine kinase inhibitor, with everolimus in solid tumors: results of a phase I study
Conclusions Vorolanib can safely be combined with everolimus. Encouraging activity is seen in RCC and NET. Further studies are warranted.Trial Registration Number: NCT01784861. (Source: Investigational New Drugs)
Source: Investigational New Drugs - September 9, 2021 Category: Drugs & Pharmacology Source Type: research

A novel histone deacetylase inhibitor LT-548-133-1 induces apoptosis by inhibiting HDAC and interfering with microtubule assembly in MCF-7 cells
SummaryMany studies have indicated that histone deacetylase inhibitors (HDACis) have a significant antitumor effect in cancer. Here we report a compound named LT-548-133-1 that not only acts as an HDAC inhibitor but also interferes with microtubule assembly to inhibit MCF-7 cell proliferation and induce apoptosis. Consistent with Chidamide, LT-548-133-1 inhibited HDAC activity and increased histone H3 acetylation. But the difference is that it significantly induced cell cycle G2/M arrest while Chidamide caused G0/G1 arrest in MCF-7 cells. By Western blotting, we found the accumulation of CyclinB1 and phosphorylated histone...
Source: Investigational New Drugs - September 9, 2021 Category: Drugs & Pharmacology Source Type: research

Identification of CDC20 as an immune infiltration-correlated prognostic biomarker in hepatocellular carcinoma
This study reveals the potential prognostic value of CDC20 in HCC and demonstrates that CDC20 may be an immune-associated therapeutic target in HCC bec ause of its correlation with immune infiltration. (Source: Investigational New Drugs)
Source: Investigational New Drugs - September 9, 2021 Category: Drugs & Pharmacology Source Type: research

Selinexor in combination with topotecan in patients with advanced or metastatic solid tumors: Results of an open-label, single-center, multi ‐arm phase Ib study
Conclusions  Once weekly selinexor in combination with topotecan was viable and showed some preliminary tumor efficacy. The recommend phase 2 dose of selinexor was 60  mg once weekly in combination with IV topotecan.Trial registration: NCT02419495. Registered 14 April 2015,https://clinicaltrials.gov/ct2/show/NCT02419495 (Source: Investigational New Drugs)
Source: Investigational New Drugs - September 9, 2021 Category: Drugs & Pharmacology Source Type: research

Effect of severe renal impairment on the pharmacokinetics of brigatinib
Conclusions These findings support a brigatinib dosage reduction of approximately 50  % in patients with severe renal impairment.Trial registry:  Not applicable. (Source: Investigational New Drugs)
Source: Investigational New Drugs - September 9, 2021 Category: Drugs & Pharmacology Source Type: research

Helicobacter pylori infection as a potential favorable factor for immune checkpoint inhibitor therapy for gastric cancer
SummaryGastric cancer (GC) has the third highest rate of cancer incidence and mortality worldwide. First-line immune checkpoint inhibitor (ICI) therapy for advanced GC led to landmark breakthroughs, but which GC patients are most likely to benefit from ICI therapy needs to be investigated in depth and identified via valuable biomarkers. In this letter, we describe superior outcomes in Asian patients than in North American and European patients treated with ICI therapy, and we speculate that positiveH. pylori status may be a beneficial prognostic factor for ICI therapy in patients with GC. Many studies have revealed thatH. ...
Source: Investigational New Drugs - September 9, 2021 Category: Drugs & Pharmacology Source Type: research

Comment on “Preclinical assessment of histone deacetylase inhibitor quisinostat as a therapeutic agent against esophageal squamous cell carcinoma”
AbstractRecently, we read a paper “Preclinical assessment of histone deacetylase inhibitor quisinostat as a therapeutic agent against esophageal squamous cell carcinoma” published in Investigational New Drugs. Quisinostat may be a promising drug candidate for the treatment of esophageal squamous cell carcinoma. However, some pro blems existing in the methods part of this paper are worthy of comment. (Source: Investigational New Drugs)
Source: Investigational New Drugs - September 9, 2021 Category: Drugs & Pharmacology Source Type: research

Antineoplastic activity of products derived from cellulose-containing materials: levoglucosenone and structurally-related derivatives as new alternatives for breast cancer treatment
Summary Breast cancer is the leading cause of cancer death among women worldwide. For this reason, the development of new therapies is still essential. In this work we have analyzed the antitumor potential of levoglucosenone, a chiral building block derived from the pyrolysis of cellulose-containing materials such as soybean hulls, and three structurally related analogues. Employing human and murine mammary cancer models, we have evaluated the effect of our compounds on cell viability through MTS assay, apoptosis induction by acridine orange/ethidium bromide staining and/or flow cytometry and the loss of mitochondrial p...
Source: Investigational New Drugs - September 3, 2021 Category: Drugs & Pharmacology Source Type: research