MBP PRODUCT OVERVIEW

PKC’s lead product using several elements of the TumorFighter™ technology platform is the Magnetic Breather Pump (MBP), which is expected to have initial application in treatment of malignant gliomas and other aggressive brain tumors. Malignant gliomas are nearly always a death sentence for patients within one to two years of treatment.  Although animal studies in mice with gliomas have demonstrated that extended delivery of medications using simple implantable pumps significantly increases survival, no implantable pumps have been developed for this purpose in humans. The MBP for local intratumoral drug delivery, which will be the first implantable pump with a catheter, can potentially eliminate repeated brain surgery procedures, reduce the cost and enhance the effectiveness of tumor fighting medications while also improving patient quality of life and increasing patient survival.

The MBP is designed to use advanced micro-fluidic, diagnostic and control mechanisms to deliver a variable, remotely programmable, metronomic combination of a plurality of tumor fighting medications within one implantable system. The MBP has four major subsystems: 1) an internalized pumping subsystem with reservoirs containing biological agents, capable of both delivering drugs at microliters/hour and sampling tumor fluids, 2) (VEGF) detector providing feedback on treatment progress, 3) an implantable control system that processes signals from the VEGF detector and other sensors and issues commands to the pumping system, and 4) an intratumoral delivery catheter (for unresectable tumors) or an intracranial pouch (for the tumor cavity in resected tumors). Pharmaco-Kinesis has successfully developed a benchtop prototype model for the MBP, named "Pathfinder," with all four components connected to demonstrate proof of principle in vitro. 

The pumping systems, VEGF detector and control system will be housed within one unit and secured at the chest wall. Multiple medication reservoirs within the MBP will be replenished through an injection apparatus. The reservoirs in the delivery pump may be accessed via subcutaneous ports to "refill" the drugs, and each reservoir can be wirelessly reprogrammed to deliver at specific time intervals and cycles. Energy is provided to the MBP through an induction charger system. The MBP is able to measure patient physical activity and position by means of a 3D accelerometer. 

The MBP is designed to provide physicians with the remote capability to administer a highly effective therapeutic regimen. The device is autonomous, self-contained and remotely programmable. These previously unavailable benefits are expected to significantly improve patient quality of life by freeing the patient from frequent visits to the doctor and eliminating the need for repeated complex brain surgeries to locally administer tumor-fighting medications.

PKC has integrated sophisticated optical sensors and other measurement systems, advanced liquid propulsion systems, microcontrollers and wireless communications to simulate the final functionality of the MBP. The MBP will provide metronomic, targeted drug delivery through a regimen programmed by the physician that can be remotely modified based on data from a closed loop "bio-lab" feedback system.

One advanced component of the MBP apparatus is a compact Optical BioSensor™ that provides real time measurement of a patient's VEGF levels in cerebrospinal or tumor fluid. Measurement of VEGF levels can indicate whether tumors are growing or shrinking. This and other information provided through the MBP measurement systems at the tumor site, such as temperature, pressure and pH, can be used to optimize treatment over time. The Company recently completed the proof-of-concept of this Optical BioLab™. A real-time diagnostic recorder provides wireless downloads of time-stamped sensor data, allowing the physician to gain granular and uninterrupted clinical information as the regimen is modified to fight the growth of aggressive tumors.

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