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Investigational New Drug - PubMed

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Last Updated: 06 August 2022

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Quality control and therapeutic investigations of mesenchymal stem/stromal cells during investigational new drug application for GvHD administration in China.

Patients with acute and chronic diseases with a prevalent secondary disease and unsatisfying results of allogeneic stem cell transplantation have developed. About half of GvHD patients were steroid-resistant, with a two-year overall survival rate lower than 20%. In the meantime, the current licensed MSC products for GvHD's administration's supervisory policies and medical ethics, as well as the concomitant advantages and challenges, have been discussed.

Source link: https://doi.org/10.2174/1574888X17666220520155212


Investigational New Drug Enabling Nonclinical Safety Assessment of the Iminosugar UV-4, a Broad-Spectrum Host-Targeted Antiviral Agent.

In single-dose and repeat-dose oral toxicity studies in mice, rats, dogs, and non-human primates, the toxicological profile of UV-4, dosed as the hydrochloride salt, was examined. Following single oral doses of dog, rats, and mice up to 250, 400, 1000 mg/kg, respectively, and in NHP up to 180 mg/kg administered three times a day for ten days, no treatment-related adverse effects were observed following single oral doses in dogs, rats, and mice up to 250, 400, 1000 mg/kg, respectively, and mice up to 180 mg/kg administered three times daily for ten days. Based on the treatment-related adverse effects observed in the identified target organs, the dog was found to be the most vulnerable species to UV-4 exposure in 14-day repeat-dose toxicology studies in mice and dogs conducted in accordance with Good Laboratory Practice guidelines. The findings of these studies reveal the effectiveness of UV-4 hydrochloride and aided in the selection of starting and maximal doses for a single ascending dose first-in-human clinical study.

Source link: https://doi.org/10.1177/10915818221077225


Investigational New Drug Enabling Nonclinical Safety Pharmacology Assessment of the Iminosugar UV-4, a Broad-Spectrum Host-Targeted Antiviral Agent.

In a respiratory safety investigation in conscious mice using whole body plethysmography, and in a cardiovascular safety study in conscious, radiotelemetry-instrumented beagle dogs, the safety pharmacology of UV-4 was tested in the in vitro human ether-go-go-go-go-go-goog-related gene assay. In the CNS study or cardiovascular assessment, there were no reported adverse treatment-related effects following the administration of UV-4 as the hydrochloride salt in the hERG potassium channel assay, on respiratory function, or in the cardiovascular study.

Source link: https://doi.org/10.1177/10915818211072842


Investigational new drug enabling angiotensin oral-delivery studies to attenuate pulmonary hypertension.

Pulmonary arterial hypertension is a lethal and uncurable disease caused by pulmonary artery narrowing and elevated pulmonary arterial pressure. The development of ANG- and ACE2 in plasma/tissues and PAH rats was hampered by decreases in right ventricular hypertrophy, RV systolic pressure, total pulmonary resistance, and pulmonary artery remodeling, according to a determinist study by monocrotaline-induced PAH rats. The addition of orally delivered protein drug bioencapsulated within plant cells has been enhanced by plant cell degrading enzymes. The first oral protein therapy to prevent/treat the disease's root cause is expected to have a positive attenuation of PAH with no toxicity augurs well for clinical development.

Source link: https://doi.org/10.1016/j.biomaterials.2019.119750

* 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