LOS ANGELES, May 26, 2015 /PRNewswire/ -- Pharmaco-Kinesis Corporation (PKC) announced today that its Neuro-Oncology Clinical Advisory Board (NOCAB) recently convened at Shutters on the Beach in Santa Monica, CA to review the development status of the Company's innovative Metronomic Biofeedback Pump (MBP), a fully smart implantable infusion device designed to locally deliver chemotherapy over time to a target site of the human body featuring metronomic drug dose delivery capacity and biofeedback system in real-time.
Dr. Thomas C. Chen, Professor of Neurological Surgery and Pathology, Keck School of Medicine, University of Southern California, and PKC Chief Neuro-Oncology Officer is the Chairman of the NOCAB. Participating board members at the third NOCAB encompassed distinguished and world-renown researchers, neuro-oncologists and neurosurgeons: Dr. Mitchel Berger, University of California San Francisco and President of American Academy of Neurological Surgery; Dr. Marc Charles Chamberlain, University of Washington; Dr. Randy Jensen, University of Utah; Dr. N. Scott Litofsky, University of Missouri; Dr. John Howard Sampson, Duke University; Dr. Michael Vogelbaum, Cleveland Clinic Foundation; and Dr. Manfred Westphal, University Clinic Hamburg-Eppendorf. Honored guests and PKC representatives attending this NOCAB were Dr. Hani Gabra, Imperial College London, Dr. Kevin O'Neill, Imperial College London, Dr. John Peterson, Ohio Clinical Trials Collaborative, Dr. Andrew Edward Sloan, University Hospitals Case Medical Center, Mr. Frank Adell, CEO of PKC and Mr. Josh Shachar, Chief Innovation Officer of PKC.
Current regimens for treatment of brain cancer often do not significantly improve length or quality of a patient's life. PKC intends to change this paradigm through a Smart Drug Delivery System™ (SDDS) technology, which is designed to provide physicians with a new modality to approach this devastating disease. "SDDS is grounded upon the idea of creating an innovative drug delivery device that will afford neurosurgeons the toolkit of options they presently desire but don't have access to, and which options they believe could improve the incidence of more favorable outcomes in patients afflicted with brain cancer. The MBP is the result of over ten years of input by some of the world's foremost medical opinion-leaders in this field," said Thomas Chen, PKC Chief Oncology Officer.
The MBP will incorporate unique features in low-dose therapeutic delivery such as the ability to continuously sample drug concentration, maintain therapeutic levels over extended periods, monitor half life of drug and change dose regiment, all remotely from a physician's hand-held tablet or computer. By contrast, a current method of chemotherapy treatment for brain cancer in usually embodies twice-weekly injections of relatively large quantities of the chemotherapeutic agent causing spikes of drug in the brain. Such high levels of drug cause unwanted side effects for the patient and diminished quality of life. To overcome this challenge, the MBP is designed to deliver a metered dose (metronomic delivery) of drug to the brain (locally) over the duration of the treatment. This strategy seeks to minimize the peak chemo-toxicity level while increasing the duration over which drug levels remain therapeutic. PKC plans to evaluate the effectiveness of this strategy in an upcoming clinical trial in patients diagnosed with leptomeningeal carcinomatosis (LC) and female patients who have also had HER2 positive breast cancer.
Said Frank Adell, "Through the invaluable insight of our NOCAB, the local, metronomic delivery and biofeedback features of our MBP device provide an unprecedented fourth modality, term coined by PKC for treatment of neurological cancer. This new fourth modality will not replace the current three methods of chemotherapy, radiation and surgical resection, but rather hopefully enhance them. The idea behind the modality is to utilize MBP features to improves drug efficacy, reduce drug side effects, enhance the duration and quality of life for patients by maintaining a therapeutic dose over extended periods and reducing unwanted chemo-toxicity. The core purpose of the third NOCAB was to update the members on progress on three fronts: product development, regulatory affairs, and upcoming human clinical trials. We were able to share some of the major milestones the company has accomplished since the last meeting, and gain invaluable feedback and insight from this group of distinguished world renown key opinion leaders that will help make the MBP a revolutionary success for the treatment of cancer as the company getting closer to commencing human clinical trials and entering the commercial market."
The day-long highly interactive session included discussions on clinical relevance, technical and regulatory progress reports since the last meeting, the design of a two-lumen interracial catheter, the biofeedback sensor, wireless communication, regulatory and compliance strategy, and novel cerebral spinal fluid stimulation modeling by the MBP team and PKC management.
"With the insight that was gleamed from the NOCAB, PKC has all the tools it now needs to move the MBP into clinical development," said Dr. Thomas Chen.
About Pharmaco-Kinesis Corporation
PKC is a pre-commercialized 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. Its novel carbon nanotube biosensor platform culminated in PKC winning the prestigious Frost & Sullivan Award in both 2013 and 2014. For more information, please go to http://www.pharmaco-kinesis.com/.
This news release contains "forward-looking statements" within the meaning of the safe harbor provisions of the United States Private Securities Litigation Reform Act of 1995. Such statements are based upon the current beliefs and expectations of the management of Pharmaco-Kinesis Corporation and are subject to significant risks and uncertainties. Actual results may differ materially from those set forth in the forward-looking statements. The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise.
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