MicroCHIPS has announced the results of the first successful human clinical trial using an implantable, wirelessly controlled and programmable microchip-based drug delivery device.
The human clinical trial was conducted on seven osteoporotic postmenopausal patients between the ages of 65 and 70. The patients received daily doses of the marketed osteoporosis drug teriparatide through microchip delivery rather than daily injection.
The trial showed that when released from the implanted microchip, the drug demonstrated similar measures of safety and therapeutic levels in blood as that of standard, recommended multiple subcutaneous injections of teriparatide.
The primary objective of the study was to determine the pharmacokinetics (PK) of the released drug teriparatide from the implanted devices. Secondary objectives included the assessment of the bioactivity of the drug and the reliability and reproducibility of releasing the drug from the device.
In the study, the PK profiles from the implant were comparable to and had less variation than the PK profiles of multiple, recommended subcutaneous injections of teriparatide.
The microchip-based implant also provided proof-of-concept measures of drug release and device durability that support implantable device viability for 12 months or more.
MicroCHIPS president and chief operating officer Robert Farra said the study data "validate the microchip approach to multi-year drug delivery without the need for frequent injections, which can improve the management of many chronic diseases like osteoporosis".
"We look forward to making further progress to advance our first device toward regulatory approvals, as well as developing a range of products for use in important disease areas such as osteoporosis, cardiovascular disease, multiple sclerosis, cancer, and chronic pain," Farra added.
MicroCHIPS co-founder Robert Langer said, "This trial demonstrates how drug can be delivered through an implantable device that can be monitored and controlled remotely, providing new opportunities to improve treatment for patients and to realise the potential of telemedicine."
The company intends to file for regulatory approval of its first microchip device in 2014.