1. Harry Wanar Rajiv Iyengar Chetram Deochand
AURIMUNE™: CYT-6091
Harry Wanar
Rajiv Iyengar
Chetram Deochand

2. 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

3. 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

4. Advantages of Aurimmune
Drug Stability
PEG “shielding”
Leakiness of tumor vasculature (EPR effect)
Passive tumor targeting
Nanoparticles = 27 nm
Large enough to avoid major organs, small enough to get into

5. 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
Doxorubicin, Paclitaxel
Regence Blue Cross, Aetna
Liposome and Albumin-bound nanotherapies respectively
Doxiline: hotline to call for financial support
Ovarian Cancer, AIDS related Kaposi’s Sarcoma
Abraxane: non small cell lung carcinoma, metastatic breast cancer
Specific financial guidelines for SPAP listed on Medicare website. Individuals with incomes below 20,000 receive 60% discount, for example.
Abraxane for advanced breast cancer
Chronic disease fund, Patient Advocate Fund, J and J fund
State Pharmaceutical assistance programs

6. 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
Uninsured individuals, Medicare Part D
Helped patients save $1.1 Billion in 2011
Gold Chloride, sodium citrate mixed in vortexed water
Aggregates of gold nanoparticles eventually form resulting in nanoparticles that are 25 nm in diameter
Has virtually no bearing on the steadily increasing price of gold given the small quantity needed

7. Therapeutic Procedures: Protocol from Phase 1 Clinical Trials
Dose escalation trials in advanced stage cancer patients
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
Lymphopenia, hypoalbuminemia, hypokalemia, hypophosphatemia, hyperbilirubinemia
Future trials to combine nanotherapy with other chemotherapeutic strategies to achieve a synergistic effect

8. 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

9. Expected Improvements
Drug accumulation at tumor site Anti-tumor responses – reducing tumor perfusion

10. Expected Complications
Fever → managed with anti-pyretics Lymphopenia →eventual redistribution Episodes of hypotension → still within normal range, and did not necessitate medical intervention

11. Future Directions
Phase II clinical trial Replicate isolated limb perfusion protocol: Administration of CYT-6091, followed by approved chemotherapies