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AURIMUNE™: CYT-6091 Harry Wanar Rajiv Iyengar Chetram Deochand Pancreatic Cancer • Most common type is Adenocarcinoma in the pancreatic duct (95% of all tumors) • Poor Prognosis • Seldom Detected in Early Stages • 75% mortality over 1 year • 94% mortality over 5 years Current Therapies Surgery • Only curative if cancer has not metastasized • But, early detection is rare Radiation • Used as adjuvant to potentially curative surgery Chemotherapy • Gemcitabine – Nucleoside analog • Tarceva – targets epithelial growth factor receptor • Both are used as palliative therapies; not curative Advantages of Aurimmune Drug Stability • PEG “shielding” Leakiness of tumor vasculature (EPR effect) • Passive tumor targeting http://www.cytimmune.com/download/video/techwor ks/tw384k.html Costs/Insurance Coverage: Comparisons Doxil and Abraxane: $2,500$5,000/dose Reimbursement assistance programs exist Covered by Medicare and private insurers for certain cancers Cheaper alternatives used first Costs/Insurance Coverage Aurimmune will be cost effective • “The bottle costs more than the particles in the bottle”--Lawrence Tamarkin, CEO • Human TNF gene was cloned in 1985 • Polyethylene glycol widely used in industry Financial assistance may be available via AstraZeneca prescription assistance Therapeutic Procedures: Protocol from Phase 1 Clinical Trials Dose escalation trials in advanced stage cancer patients • 50-600 μg/m^2 tested for safety IV injection on Day 1 and 15 Tumor biopsies indicated strong presence of gold particles Maximum Tolerated dose (MTD) of toxic TNF raised 3-fold with nanotherapy Recovery Protocols After treatment, monitored in hospital for 48 hours → discharged as outpatients After second dose, patient returns for evaluation If at time of evaluation (2 months after) patient had stable disease or partial response, was eligible for retreatment Report all adverse events experienced, from fatigue to nausea Expected Improvements Drug accumulation at tumor site Anti-tumor responses – reducing tumor perfusion Expected Complications Fever → managed with anti-pyretics Lymphopenia →eventual redistribution Episodes of hypotension → still within normal range, and did not necessitate medical intervention Future Directions Phase II clinical trial Replicate isolated limb perfusion protocol: Administration of CYT-6091, followed by approved chemotherapies