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Investigational New Drug - Crossref

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Last Updated: 06 August 2022

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Abstract 4482: Development of localized cisplatin chemotherapy: from benchside to investigational new drug application

The aim of this research is to produce intralymphatically targeted cisplatin nanoparticles for treating locally advanced head and neck cancer. Both humans and companion animals have significantly reduced the side effects and increased the effectiveness of cisplatin-based chemotherapy in both humans and companion animals relative to standard intravenous chemotherapies, with this treatment strategy. In mice carrying cisplatin sensitive xenografts, anti-cancer effectiveness of HA-Pt was established. Perpetuorally, Canines with spontaneously-occurring oral squamous cell carcinoma, oral melanoma, or nasal tumors received three doses of 10 to 15 mg/m2, peritumorally. With continuing supply of cisplatin, HA-Pt demonstrated antiproliferative activity in vitro similar to standard cisplatin in vitro. Rats with HA-Pt resulted in a heightened plasma area-under-the-curve and lower Cmax. Compared to standard cisplatin therapy, Murine xenografts demonstrated improved complete and partial responses to HA-Pt therapy. Compared to i. v. , the HA-Pt decreased Cmax by 5. 5 fold and raised the canine plasma AUC of cisplatin 5. 4 fold and boosted the lymph node concentration 18 fold. The tumor:plasma ratio in canines was 429, indicating that the nanoparticles concentrated drug within the tumor. A single injection of HA-Pt resulted in the size reduction of the canine oral melanoma's metastatic lymph nodes. This review shows that subcutaneous administration of HA-Pt formulations may be a promising treatment regimen to reduce tumor drug accumulation and therapeutic efficacy. An Investigational New Drug Application will be submitted to the FDA after the successful completion of a series of GLP rodent and canine studies. From benchside to investigational new drug use, the introduction of localized cisplatin chemotherapy has progressed.

Source link: https://doi.org/10.1158/1538-7445.am2014-4482


Abstract 5115: Enhancing data quality for clinical studies of investigational cancer immunotherapy drug candidates by a new data analytics tool

Abstract Cancer immunotherapy is quickly becoming a treatment of choice in fighting deadly cancers, particularly late stage or metastatic cancers. The biggest challenges with flow cytometry in the clinical trial setting are the determination of the amount of data collected and the absence of replicable benchmarks for each pair of biomarkers, which refers to leukocyte specifics and functions. Previously, we introduced a new way to increase data quality in scientific study by big data analytics and data visualization. Here we introduce widening the use of the new analytic device in the field of flow cytometry and cancer immunotherapy. Multiple fluorescence signals are measurable at once, and antibodies directed against specific cellular proteins can be conjugated with a variety of fluorochromes. This new data analytic system can be used to improve flow cytometric measurements, such as antibody quality and data validation, as well as increase in staff training and administration of proficiency testing, can all be enhanced by this new data analytic device. Clinical trials in the near future will be more effective, with artificial intelligence and machine learning. A new data analytics system [abstract] is designed to improve data quality for scientific trials of investigational cancer immunotherapy drug candidates by an investigational cancer immunotherapy drug candidates. AACR; Cancer Res 2019; 5115 Abstract nr 5115. The American Association for Cancer Research Annual Meeting, 2019 Mar 29-Apr 3; Atlanta, GA.

Source link: https://doi.org/10.1158/1538-7445.am2019-5115

* Please keep in mind that all text is summarized by machine, we do not bear any responsibility, and you should always check original source before taking any actions

* Please keep in mind that all text is summarized by machine, we do not bear any responsibility, and you should always check original source before taking any actions