Pharmacologic Intervention with CMX-2043 for the Acute Treatment of Neurotrauma and Traumatic Brain Injury (TBI)
Abstract
The initial phases of the study began late in the third quarter, having been delayed by the closing of the Kilbaugh lab for approx. six months due to Covid-19 pandemic. However, during the fourth quarter it was decided that the dose levels to be evaluated in this dose response/PK study should be increased on a mg/kg basis. The reason we have decided to increase the dose level is that earlier in 2020 we requested CRL to perform a single-dose, maximum tolerated dose study (the MTD study) to confirm the dose levels we had originally envisioned for the repeat-dose tox study. (This MTD study was not originally thought to be necessary, was not planned as a part of the Award, and, consistent with the fixed-price nature of the Award, was paid for 100% by Ischemix.) The result of the MTD study was that no toxicity was seen at levels up to and including 320 mg/kg. Therefore we have decided to increase the amount of drug to be administered in higher dose groups of the dose response/PK study to accommodate a potentially higher efficacious dose in later human studies than was originally anticipated.
Document Details
- Document Type
- Technical Report
- Publication Date
- Jan 25, 2021
- Accession Number
- AD1123960
Entities
People
- Todd J. Kilbaugh