A human trial successfully used an implanted, programmable, wireless microchip to deliver teriparatide, a bone drug for post-menopausal females who had been diagnosed with osteoporosis, researchers from MicroCHIPS, Harvard Medical School and MIT reported in the journal Science Translational Medicine. The authors added that that this automated system is just as safe and effective, and much more convenient than multiple subcutaneous injections, the standard therapy.
Lead author, Robert Farra, MicroCHIPS President and Chief Operating Officer, said:
"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.
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."
In this study, seven post-menopausal females who had been diagnosed with osteoporosis received teriparatide, a medication for the treatment of osteoporosis, through microchip delivery for four months, instead of receiving an injection every day. The participants were aged between 65 and 70 years.
The human study's main aim was to assess the PK (pharmacokinetics) of teriparatide which was being released from the implanted microchips. Pharmacokinetics looks at the action of a drug in the human body over a set time - its process of absorption, distribution, localization in tissues, biotransformation, and excretion. They also assessed teriparatide's bioactivity, and evaluated its reliability and "reproducibility of releasing the drug from the device".
The implanted microchip and teriparatide were found to be biocompatible; there were no adverse immune reactions. In fact, the implant's PK profiles were comparable and had fewer variations compared to that of injected teriparatide. The implant was also found to deliver teriparatide at the right times. "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".
Local anesthetic was used when the microchip was implanted, and again when it was explanted. According to this study, the device was well tolerated and the women said they would repeat the procedure.
Treating surgeon, Pia Georg Jensen, MD., said:
"Each procedure lasted less than 30 minutes. The patients were able to walk out of the facility and go home unescorted."
Patients' biological markers of bone formation (P1NP), and bone resorption (CTX) were measured to assess efficacy and bone fracture risk improvement. Changes in serum calcium, CTX and P1NP caused by the drug implant therapy were similar to those found in other studies that measured results from teriparatide injections.
Co-author, Robert Neer, said:
"A microchip that continues to deliver teriparatide with this or similar consistency and efficiency over 12 to 24 months could improve bone mass, density, architecture, and strength."
Co-author, Robert Langer, ScD, 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 realize the potential of telemedicine. The convergence of drug delivery and electronic technologies gives physicians a real-time connection to their patient's health, and patients are freed from the daily reminder, or burden, of disease by eliminating the need for regular injections."
Written by Christian Nordvist