[{"orgOrder":0,"company":"CervoMed","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Diffusion Pharmaceuticals Evaluating TSC Against Acute Respiratory Distress Syndrome (ARDS) in COVID-19 Patients","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Undisclosed","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"April 2020","url1":"","url2":"","graph1":"Infections and Infectious Diseases","graph2":"Undisclosed"},{"orgOrder":0,"company":"CervoMed","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Diffusion Pharmaceuticals Announces Pre-IND Submission to the FDA of Design for TSC Trials to Treat ARDS in COVID-19","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Preclinical","country":"U.S.A","productType":"Small 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Find Clinical Drug Pipeline Developments & Deals for Trans Crocetinate Sodium
Trans sodium crocetinate (TSC), is being developed to enhance the diffusion of oxygen to tissues with low oxygen levels, also known as hypoxia, a serious complication of many of medicine’s most intractable and difficult-to-treat conditions.
Diffusion aligns with FDA on design of an open-label, dose-escalation, Phase 2 safety and efficacy study of trans sodium crocetinate (“TSC”) in newly diagnosed glioblastoma multiforme (“GBM”) patients.
Positive effects for Trans Sodium Crocetinate on post-exercise recovery based when comparing measurements 10 min post-exercise to measurements at the end of the exercise interval.
Trans sodium crocetinate (TSC), is being developed to enhance the diffusion of oxygen to tissues with low oxygen levels, also known as hypoxia, a serious complication of many of medicine’s most intractable and difficult-to-treat conditions.
Company’s lead product candidate, trans sodium crocetinate (“TSC”), in normal healthy volunteers subjected to incremental levels of physical exertion while exposed to hypoxic and hypobaric conditions, or simulated altitude.
In this trial, transcutaneous oxygen monitoring (“TCOM”) was used to measure the direct pharmacodynamic effects of TSC on peripheral tissue oxygenation in healthy normal volunteers.
Topline results based upon analyses of primary endpoint data from trial announced in February 2021, indicating that trans sodium crocetinate in hospitalized COVID-19 patients was safe and well-tolerated when administered on more frequent dosing regimen
The TCOM trial is a randomized, double blind, placebo controlled, pharmacokinetic, pharmacodynamic study of TSC that will enroll up to 30 healthy volunteers.
The external safety monitoring committee, established as part of the trial protocol, met to review safety data from the final, 1.5 mg/kg dose of TSC, cohort and determined that no dose-limiting toxicities or serious adverse events were observed.
The Phase 1b study trial will be a randomized, placebo-controlled safety and efficacy study of TSC in hospitalized COVID-19 patients that will be conducted in the United States and Europe after consultation with, and approval from, local regulatory authorities.
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