PHARMACO-KINESIS FORMALIZES AGREEMENT WITH USC TO PERFORM LARGE ANIMAL STUDIES
Animal Studies to Begin by August 23, 2010

INGLEWOOD, CALIFORNIA, August 4, 2010 – Pharmaco-Kinesis Corporation (PKC), an advanced medical device company developing smart local drug delivery systems, today reported formalizing an agreement with the University of Southern California (USC) to begin animal testing for the efficacy and robustness of PKC's Metronomic Biofeedback Pump (MBP).

PKC's porcine animal studies are scheduled to span 12 months. The non-survival animal studies will begin on August 23, 2010 at PKC's in-house lab. In September 2010 PKC will continue non-survival animal studies at USC's vivarium facilities, and in the following months begin survival animal studies. Survival animal studies will involve up to five live animals implanted with simultaneously active MBP devices. The data collected from these animal studies will be utilized to support the MBP's use for treatment of brain, stomach, liver, pancreas, and ovarian cancers.

The studies will investigate the MBP's liquid-to-liquid delivery by establishing the concentration of methotrexate (MTX) in the cerebrospinal fluid (CSF) after metronomic, localized delivery of the drug using the MBP. Liquid-to-liquid delivery is critical to treatment of leptomeningeal carcinomatosis (LC). The large animal studies will also validate PKC's proprietary Computational Fluid Dynamics 3D computer model of diffusion within the brain. Results will be confirmed with CINE MRI scans, CT-scans using Isovue infusion for contrast, CSF withdrawals, and SPECT scans of the animal subjects.

MTX is a critical chemotherapeutic drug in the fight against brain cancer and cancers of the central nervous system. The first application of the MBP is expected for treatment of LC, a devastating complication of cancer that attacks the brain and travels in the spinal fluid. “Despite significant improvements in chemotherapy, radiation therapy and surgery for many types of cancer, the prognosis is dismal for patients with LC. Untreated patients survive for approximately 6-8 weeks, and even with aggressive treatment using current methods, the average survival for LC patients with solid tumors is approximately 4-8 months.” said Thomas C. Chen, M.D., Ph.D., Chief Oncology Officer of PKC. “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. The MBP can improve the survival rates and the quality of life of LC patients." 

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 a programmable polypharmacy infusion apparatus which enables the clinician to personalize the treatment regimen based on patient-specific parameters,” said Josh Shachar, Chief Technology Officer of PKC. “This device delivers chemotherapy intratumorally and enables delivery based on pharmacokinetic criteria such as bioavailability, bioelimination and toxicity, relative to maximum tolerated dose (MTD), as well as optimal biological dose (OBD). Physiological parameters are monitored by a “smart loop” and governed by sensory outputs."

"When the MBP has show success in treatments related to LC, it can then be applied to other cancers. The MBP can be adapted to provide personalized treatment for brain, stomach, liver, pancreas, and ovarian cancers. We believe the MBP will revolutionize the entire field of cancer therapy, especially for cancers such as Glioblastoma Multiforme (GBM) where there are few effective options" said Frank Adell, President and CEO.

The commencement of large animal studies is a critical milestone in the development of the MBP, and successful completion will pave the way for commencing Phase I/II studies in humans in 2011. The MBP is the central product in PKC's line of novel, smart, local drug delivery technologies and advanced devices to measure biological responses.

For additional information, please contact:
Daniel Saks Senior
Vice President, Corporate Affairs
Pharmaco-Kinesis Corporation
(310) 734-4447