PHARMACO KINESIS CORPORATION TO CONDUCT FIRST HUMAN STUDIES USING METRONOMIC BIOFEEDBACK PUMP AT LA PAZ HOSPITAL IN MADRID, SPAIN

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.

http://www.youtube.com/watch?v=PSYMPYhKWc4

PATHOGENIC BACTERIA IN FOOD/BEVERAGE SAMPLES – SPECIFIC APPLICATIONS

Pathogenic bacteria are among the main causes of death in the world, with food and beverages accounting for the major vectors of infectious transmission. Each year food and beverage-borne pathogens are responsible for massive public health costs, including sick days, medical expenses, and preventable deaths [1]. The PKC Biosensorfor bacterial detection is designed to recognize the highly pathogenic E. coli O157:H7 bacteria. In the US alone,  E. coli O157:H7 accounts for approximately 73,000 illnesses and 60 deaths each year [2]. The PKC Biosensor offers the possibility of multiple and frequent tests due to the simplicity of the assay. By using specialized receptors, our sensor overcomes the significant challenge of detecting strictly viable E. coli in a sample that might be orders of magnitude richer in dead E. coli. Now with the PKC Biosensor, a qualitative measurement of viable pathogenic bacteria can be performed in a single step, unattended, and in real-time. 

 

Pathogenic Bacteria Detection

 

REFERENCES

1. Nyachuba, D.G., Foodborne illness: is it on the rise? Nutrition Reviews, 2010. 68(5): p. 257-269

2. Brabban, A.D., E. Hite, and T.R. Callaway, Evolution of Foodborne Pathogens via Temperate Bacteriophage-Mediated Gene Transfer. Foodborne Pathogens and Disease, 2005. 2(4): p. 287-303

ON-BOARD BIOFEEDBACK

 

Despite efforts to individualize dosages, toxicity and efficacy outcomes of chemotherapy vary considerably among patients due to the highly variable and unpredictable biochemistry of the individual. Dosages based on monitoring drug concentration levels have been shown to improve therapeutic outcome of many chemo agents. Drug concentration level measurement in brain fluid provides clinicians feedback to ascertain toxicity level and optimize the administration of chemotherapeutics by adapting the dosage.

 

The MBP incorporates an on-board sensor which can be tuned to monitor varying concentrations of medications in the brain fluid.  This sensor has currently been tested and shown to be effective in monitoring drug concentrations in real time.

 

 

On-board Biofeedback 

 

After testing our sensor with known concentrations of a specific medication and comparing the results with those from a commercially available tabletop scanner, we found our sensor to be accurate. We performed in vitro tests with a closed circuit fluidic system where known amounts of methotrexate were added to liquid which was constantly being circulated past the sensor. The plot above shows that the sensor was able to accurately detect the concentration over time.

 

SUPPORTING LITERATURE

  • Pharmacokinetically Guided Dose Adjustment of 5-Fluorouracil: A Rational Approach to Improving Therapeutic Outcomes, M. Wasif Saif, Adrienne Choma, Salvatore J. Salamone, Edward Chu, Journal of Clinical Investigation 2000; vol 105, issue 101: 1-10, 2009Available here.

     

  • Spectrophotometric Method for Determination of Methotrexate, Sildenafil Citrate and Trimetazidine Dihydrochloride in Pharmaceutical Formulations, J. K. Verma and H. A. Syed, Journal of Pharmacy Research 2010, 3(3),615-617Available here.

METRONOMIC DELIVERY

 

An example of a typical treatment regimen calls for a twice-weekly schedule for 3-4 weeks, followed by a reduction in frequency over a total period of 3-6 months. An alternative treatment based on metronomic delivery infuses numerous small doses over time. This strategy attempts to minimize the peak chemo toxicity level while increasing the duration over which drug levels are therapeutic. This concept is illustrated in the simulation data below.

 

 

Metronomic Delivery 
A recent study shows that continuous intrathecal treatment with methotrexate via subcutaneous port improved the therapeutic effect and reduced the complications associated with treatment of cancer. The frequent small drug doses over a short period were shown to reduce the incidence of complications by enabling long term CSF exposure to cytotoxic drug concentrations while avoiding excessively high and potentially neurotoxic drug concentrations. We hypothesize that patient survival time can be increased by a personalized metronomic delivery system, which could result in a sustained higher chemotherapy concentration (greater therapeutic effect) yet achieve a lower peak drug concentration (less toxicity) at various parts of the brain.

 

SUPPORTING LITERATURE

  • Continuous low-dose anti-angiogenic/metronomic chemotherapy: from the research laboratory into the oncology clinic, R. S. Kerbel, G. Klement, K. I. Pritchard & B. Kamen, Annals of Oncology 13: 12-15, 2002Available here.

     

  • “Concentration x time” methotrexate via subcutaneous reservoir: a less toxic regimen for intraventricular chemotherapy of central nervous system neoplasms. Bleyer WA, Poplack DG, Simon RM. Blood 1978;51(5):835-842Available here.

     

  • Metronomic low-dose oral cyclophosphamide and methotrexate plus or minus thalidomide in metastatic breast cancer: antitumor activity and biological effects, M. Colleoni, L. Orlando, G. Sanna, A. Rocca, P. Maisonneuve, G. Peruzzotti, R. Ghisini, M. T. Sandri, L. Zorzino, F. Nole, G. Viale & A. Goldhirsch, Annals of Oncology 17: 232–238, 2006Available here.

     

  • Less is more, regularly: metronomic dosing of cytotoxic drugs can target tumor angiogenesis in mice, Douglas Hanahan, Gabriele Bergers, Emily Bergsland, Journal of Clinical Investigation 2000; vol 105, issue 8:1045–1047Available here.

ON-BOARD BIOFEEDBACK

 

Despite efforts to individualize dosages, toxicity and efficacy outcomes of chemotherapy vary considerably among patients due to the highly variable and unpredictable biochemistry of the individual. Dosages based on monitoring drug concentration levels have been shown to improve therapeutic outcome of many chemo agents. Drug concentration level measurement in brain fluid provides clinicians feedback to ascertain toxicity level and optimize the administration of chemotherapeutics by adapting the dosage.

 

The MBP incorporates an on-board sensor which can be tuned to monitor varying concentrations of medications in the brain fluid.  This sensor has currently been tested and shown to be effective in monitoring drug concentrations in real time.

METRONOMIC BIOFEEDBACK PUMP OVERVIEW

 

The Metronomic Biofeedback Pump (MBP) is a fully implantable smart infusion device, designed to locally deliver chemotherapies or medication over time to a target site.  Current methods of treatment for brain cancer using chemotherapy require a patient to visit a doctor for twice weekly injections of relatively large quantities of the drug, causing spikes in the concentration present in the brain. The MBP seeks to improve on this by gradually delivering medication over time in smaller doses.  This minimizes initial peak concentrations as well as maintains effective levels of the drug over the duration of the treatment. It has been shown in a recent study that continuous treatment with chemotherapy improves the therapeutic effect and reduces the complications that commonly occur during the course of treatment.

 

 

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