As a result of meeting at SNO 2023 and recent very productive on-line meetings we're excited to partner with the team at Monteris on optimizing LITT for LTSL-Dox delivery.  We need to  optimize the existing LITT software that already "... delivers superior visualization that allows surgeons to see more of the procedure to execute every procedure confidently".  We need to investigate how to modify the warming protocol from its usual abaltion mode, specifically for the reduced temperatures required for LTSL-Dox drug release in the invasive margins of brain tumors.  The goal here is to test new revised software and protocol in order to obtain important data on extent of warming and dox release from LTSL-Dox.  We are therefore planning to study thermal dose-dynamics of optimized LITT, doxorubicin drug tissue-distribution, effects on healthy tissue, and drug pharmacokinetics in a healthy pig brain. We estimate the cost to be $50,000. 

Companion dogs have brain tumors too, and so prior to a Phase I in humans, we are currently planning a small clinical trial in canine patients with Glioma to test LITT + LTSL-Dox for safety and efficacy that will then inform the human phase I protocol.  We are planning the trial in 10 canine patients which is estimated to cost $20,000 per patient, and so a total of $200,000. 

Sponsoring one dog in a trial would therefore be $20,000.

Any amount helps. 

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 12 human patients with recurrent Glioblastoma, at an initial estimated cost of ~$1.2M.  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.

And again, any donation helps.