A preclinical study in pigs will be our first project to fund.
Then the Canine Glioma trial will be the next project we are raising money to cover. Upon a successful canine trial, it will be followed by a Phase I trial in humans testing the LITT + LTSL-Dox for safety.
In addition we plan to raise funds dedicated to overhead, and operations for DNKO, and also to enable additional scientific discovery, research and outreach collaborations.
While we know there are large amounts of funds required, (see below) any amount helps. We're in the process of setting up donation channels, please contact kate@DNKO.net in the interim.
We are underway on a study for thermal dose-dynamics of optimized LITT, doxorubicin drug tissue-distribution, effects on healthy tissue, and drug pharmacokinetics in healthy and tumor bearing pig brains. We estimate the cost to be $50,000-$150,000.
If the canine study LITT + LTSL-Dox shows safety and even efficacy, then we will want to move swiftly to a Phase I safety trial in 25 human patients with recurrent Glioblastoma, at an initial estimated cost of ~$2.5M. There may also be an opportunity to apply for approval and carry out compassionate use.
Cost here are estimated to be ~$100,000 per patient, and, again, could represent a dedicated donation for one patient to participate and perhaps get the benefits of this new combination technology.