Cleveland Clinic spinout Infuseon Therapeutics said today that its novel central nervous system delivery device won 510(k) clearance from the FDA as a therapeutic delivery device.
The company’s Cleveland Multiport Catheter, which won FDA clearance in March, was designed to effectively deliver therapeutics to the brain. Usually, the blood brain barrier prevents drugs delivered in traditional methods from reaching their target.
The device is composed of 4 independent delivery microcatheters and was initially approved to deliver chemotherapy to the ventricles of the brain. Infuseon said the CMC is being evaluated in IND-based pilot clinical trials as a loco-regional delivery device with an MRI-visible tracer in patients with recurrent high grade gliomas.
“This clearance of the CMC is important to developers of drugs and biologics that are intended for direct delivery to the CNS, as they are looking to use an FDA-cleared catheter for their IND-based clinical trials,” Dr. Michael Vogelbaum said in prepared remarks.
Vogelbaum is a professor of neurosurgery at the Cleveland Clinic Lerner College of Medicine and associate director of Cleveland Clinic’s Rose Ella Burkhardt Brain Tumor and Neuro-Oncology Center. He also designed the device.
The 1st patient was treated with the CMC in December 2014 and since then, 12 patients with malignant glioma have finished treatment with the device. In these procedures, 2 CMC devices were placed in each patient using traditional neurosurgical stereotactic methods. Researchers infused a chemotherapy and an MRI-visible tracer into the tumor or tumor-infiltrated brain tissue using the microcatheters for up to 96 hours.
Using intermittent MRI monitoring, the company has seen that the infusate widely distributed into the tumor-infiltrated brain thanks to the delivery device.
“The extent of brain tissue covered and the reliability of the technique in these patients to date have surpassed past experience with other CED devices,” Vogelbaum said.
The company reported that it will continue to conduct additional studies to set optimal parameters for use of the CMC in solid tumors and in tumor-infiltrated brain. Infuseon also said it plans to identify other conditions affecting the brain, CNS and solid organs that could benefit from treatment with the device.
The company is on the look-out for strategic partners with proprietary agents that could be delivered through the CMC, Infuseon added.
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