INGLEWOOD, CALIFORNIA, June 27, 2011 – Pharmaco-Kinesis Corporation (PKC), a medical device company developing smart local drug delivery systems, today announced plans to begin human clinical trials during 2012 using the company’s implantable Metronomic Biofeedback Pump (MBP™) at University Hospital La Paz in Madrid, Spain.
Dr Thomas Chen, MD, PhD, Chief Oncology Officer of PKC and Director of Surgical Neuro-oncology at the University of Southern California, will supervise human study clinical protocol to be conducted under the direction of Dr. Cristobal Belda-Iniesta, MD, PhD, Director of Translational Oncology and Experimental Therapeutics Unit at La Paz Hospital. This protocol was submitted to La Paz Hospital on June 28, 2011.


“The MBP allows metronomic local delivery of chemotherapy directly into a tumor or tumor bed to achieve superior local control. Our first treatment will be for patients with leptomeningeal carcinomatosis, a condition in which cancer cells spread into the cerebrospinal fluid. This is almost uniformly a deadly condition that is currently undertreated. It is our hope that our new treatment protocol will improve the survival time and quality of life for these patients,” said Dr. Chen.  With a median survival time of 4 to 6 weeks if untreated, leptomeningeal metastasis is one of the most aggressive forms of cancer. Current treatment involving almost daily hospital visits to receive manual chemotherapeutic injections directly in the brain only prolongs patient survival time to 6 to 9 months.





About the MBP

Current treatments for cancer have relied primarily on combination therapy using surgical removal, systemic chemotherapy, and radiation therapy. The MBP represents a fourth treatment modality by using localized, programmable delivery of drugs based upon the patient’s specific physiology. The MBP is the first fully implantable pump specifically designed for local, metronomic delivery of chemotherapeutic agents.  It not only delivers a variety of medications to a treatment location but also obtains sample fluid from the tumor via its multi-lumen catheter, closing the feedback loop in patient-specific treatments. “Multiple studies have shown that continuous flow of medication, administration of alternate drug regimens or drug combinations, and adaptation of dosage to individualized patient needs can improve survival rates, but as yet no device has been developed with these capabilities,” said Dr. Chen. The MBP automatically dispenses precise quantities of chemotherapeutics directly to the site of cancer according to delivery regimens prescribed by the physician. This treatment modality has the potential to considerably improve quality of life for patients with LC and a range of cancer conditions.


About PKC

PKC is an early-stage high technology medical device company that aims to optimize healing of the human body through proprietary local Smart Drug Delivery Systems™ (SDDS) and associated advanced devices to measure biological responses.