Robert Noyce and Jack Kilby would never have thought their invention of microchip could revolutionize healthcare. Almost 52 years after their invention, an American company has come up with an implantable microchip-based device to deliver drugs, which could revolutionize treatment of several diseases.
Massachusetts-based MicroCHIPS announced the first successful human clinical trial of an implantable, wirelessly controlled and programmable microchip-based drug delivery devise for management of osteoporosis. The results of human trials of the chip were published in the on-line edition of the journal ‘Science Transnational Medicine’ by the company.
“These 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 where adherence to therapy is a significant problem,” said study lead author Robert Farra, MicroCHIPS President and Chief Operating Officer. “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.”
A microchip is a small semiconductor used to relay information, which is at the heart of many electronic devises today, including computers, mobile devices and even microwave ovens.
During the trial, post menopausal women diagnosed with osteoporosis were given daily doses of available drugs through microchip delivery instead of 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 primary objective of the study was to assess pharmacokinetics (PK) or reaction of the drugs on organs. It demonstrated, the programmable implant was able to deliver the drug at scheduled intervals. It also evaluated the biological response to the implant and monitoring indicators of toxicity. The secondary objectives were to assess the bioactivity of the drug and to evaluate the reliability and reproducibility of releasing the drug from the device.
The device and drug combination were found to be biocompatible with no adverse immune reaction. The results of PK profiles from the implant were comparable to and had less variation than that of multiple, recommended subcutaneous injections of teriparatide. The study demonstrated that the programmable implant was able to deliver the drug at scheduled intervals and provided proof of the viability of the implantable device for a life of 12 months or more.
“A microchip that continues to deliver teriparatide with this or similar consistency and efficiency for over 12 to 24 months could improve bone mass, density, architecture and strength,” said the co-author of the study Robert Neer of Massachusetts General Hospital Bone Density Centre.
“The convergence of drug delivery and electronic technologies give physicians a real-time connection to their patient’s health and patients in turn, are freed from the daily reminder or burden of disease by eliminating the need for regular injections,” said Robert Langer, co-author of the study and Professor at the David H. Koch Institute for Integrative Cancer Research at MIT and cofounder of MicroCHIPS.
The device is implanted or explanted using local anesthesia, lasting less than 30 minutes and the patients will be able to walk home unescorted.