Download May 1 - (canvas.brown.edu).

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