Alcyone Lifesciences announced the first successful clinical use in a pediatric patient of its Alcyone MEMS Cannula (AMC) platform in a Phase 1 study for a certain type of brain tumor called diffuse intrinsic pontine glioma (DIPG).
Alcyone MEMS Cannula
DIPG is a highly aggressive, infiltrative tumor of the brainstem that typically affects children aged four to 11 years. There is no effective treatment, and due to the difficult anatomical location of the tumor, surgical resection is often not possible, and effective intratumoral drug infusion can be challenging.
The open-label, dose-escalating study is evaluating the safety and efficacy of single dose DNX-2401 delivered with Alcyone's AMC system for pediatric patients with newly diagnosed DIPG at the Clínica Universidad de Navarra in Pamplona, Spain.
"Reflux free delivery and biodistribution is critical in intratumoral delivery of therapeutics. The delivery system is even more paramount when treating deep brain diseases such as DIPG," said Dr. Sonia Tejada, M.D., Ph.D., of Clinica Universidad de Navarra. "The AMC system is a much-needed technology to infuse new treatments for brain tumors; in this case we have infused an oncolytic virus, although AMC could be of use with many other oncolytics."
The Alcyone MEMS Cannula (AMC) Targeted Delivery System was developed using the company's proprietary microelectromechanical system (MEMS) technology platform. The MEMS tip which has dual micro-channels, the AMC features a unique patented distal end design that helps prevent reflux or back flow along the cannula shaft, which can be a significant drawback with current devices. The AMC platform device is designed for optimal targeted bio-distribution and neurosurgeon's ease of use. The AMC can be utilized with any existing commercial imaging and stereotactic system in conjunction with the work-flow friendly clinical use guidelines designed by the company's scientific and neurosurgery advisors. Neurosurgeons can select a target, navigate the AMC precisely to the target, and observe in real-time the precision delivery of the therapeutic agent, all under intra-procedural MRI guidance.