Clinical trial of the programmable implantable Wireless Microchip Drug Delivery Device shows promise in treating osteoporosis
About 15 years ago, MIT professors Robert Langer and Michael Cima had the idea to develop a programmable, wirelessly controlled microchip that would deliver drugs after implantation in a patient’s body. The MIT researchers and scientists from MicroCHIPS reported today the results of the first successful human clinical trial with an implantable, wirelessly controlled and programmable microchip-based drug delivery device. In the trial, post-menopausal women diagnosed with osteoporosis received daily doses of the marketed osteoporosis drug teriparatide through microchip delivery rather than daily injection. The drug released from the implanted microchip demonstrated similar measures of safety and therapeutic levels in blood to what is observed from standard, recommended multiple subcutaneous injections of teriparatide.
The device and drug combination were found to be biocompatible with no adverse immune reaction. The resulting PK profiles from the implant were comparable to and had less variation than the PK profiles of multiple, recommended subcutaneous injections of teriparatide.The study also demonstrated that the programmable implant was able to deliver the drug at scheduled intervals. Drug delivery and evaluation in patients occurred over a one month period and provided proof-of-concept measures of drug release and device durability that support implantable device viability for 12 months or more. The microchip device was implanted and explanted using local anesthetic.
Implantable medical devices such as pacemakers and pain pumps perform important functions to help patients return to a healthier state and to manage their disease.The design of a next-generation microchip drug delivery device is the only approach to an implantable device that can be wirelessly programmed to release drugs inside the body without percutaneous connections in or on the patient. An implantable microchip device also provides real-time dose schedule tracking, and as part of a network, physicians can remotely adjust treatment schedules as necessary. MicroCHIPS plans to file for regulatory approval for its first microchip device in 2014.