Dynamic CEDTM
The Precision NeuroMed Solution
With oral or intravenous drug delivery, <0.1% of small molecules enter the brain, and <0.006% of protein based therapies enter the brain due to the BBB.
The Problem
The Biggest Challenges in Achieving Clinical Efficacy
For many brain diseases, including glioblastoma, stroke, epilepsy, Parkinson’s, Alzheimer’s, and many others, better drugs have been developed, but we still lack approved disease-modifying therapies. One of the biggest challenges in achieving clinical efficacy is delivering effective drug concentrations to the brain. The blood-brain barrier (BBB) blocks most drugs from entering the brain, or requires such high doses that systemic side effects become a significant issue.
Convection-enhanced delivery (CED) bypasses the blood-brain barrier to deliver therapeutic agents directly and precisely to diseased areas of the brain. This approach enables uniform drug distribution while significantly reducing or eliminating systemic toxicity.
CED utilizes a minimally invasive procedure in which a computer-guided microinfusion catheter is temporarily placed to administer the drug. The drug is slowly infused directly into the targeted brain tissue, achieving concentrations up to 1,000,000 times higher than those possible with intravenous delivery—far surpassing the 10-fold increase of focused ultrasound BBB disruption or the 40-fold increase of receptor-mediated transport.
This scalable platform supports the delivery of diverse therapeutic agents, including small molecules, proteins, liposomes, and AAV-based gene therapies. By combining unparalleled precision with the ability to target challenging neurological conditions, CED represents a transformative advancement in the treatment of brain diseases.
Hardware
Advanced Drug
Delivery Technology
By leveraging insights from multiple previous studies, our catheter not only facilitates surgical workflow but also ensures placement accuracy improving drug distribution through a minimally invasive procedure, eventually allowing for outpatient therapy.
Software
Treatment
Planning Software
PNM’s treatment planning software includes an FDA-cleared predictive drug distribution algorithm that integrates fluid and drug flow dynamics based on the patient’s specific brain and disease anatomy. Utilizing standard MRI sequences, the software will incorporate an AI-driven predictive algorithm to provide precise, patient-specific planning for loco-regional drug delivery. This advanced software eliminates surgical variability and reduces the need for extensive surgical training.
Drug
First Drug/Target Disease
PNM is reintroducing IL13-PE38, a potent cytotoxic protein that selectively binds to the IL13alpha2 receptor found on GBM stem cells, while sparing healthy brain tissue. IL13-PE38 is effective against hypoxic cells and functions independently of the cell cycle, with no known mechanisms of resistance. Remarkably, it is active at pico-molar concentrations, where the internalization of just one or a few molecules can induce tumor cell death. Through PNM’s advanced drug delivery platform, therapeutic concentrations of drug can be safely delivered to the tumor-infiltrated regions of the brain, without causing systemic toxicity.