Renovorx, Inc. · NASDAQ:RNXT
Renovorx — Technical Presentation (April 2017)
20 slides from Renovorx's technical presentation, Apr 2, 2017
Slide 1: Intra-arterial Targeted Delivery of Gemcitabine in Treatment of Patients with Loco-regional Pancreatic Tumors
Intra-arterial Targeted Delivery of Gemcitabine in Treatment of Patients with Loco-regional Pancreatic Tumors Alexander Rosemurgy, M.D., Sharona Ross, M.D., Paul Vitulli, M.D., Florida Hospital – Tampa, Tampa, FL Reza Malek, M.D., Jiali Li, M.D., Ramtin Agah, M.D., El Camino Hospital – Mountain View
Slide 2: Disclosures
Disclosures The study was funded by RenovoRx (Los Altos, CA)
Slide 3: Aim, Methods and Results
Aim: A dose escalation study of Gemcitabine for treatment of unresectable pancreatic cancer, using a targeted intra-arterial delivery catheter (RenovoCath™). Methods: 20 patients at two centers were enrolled with a four- stage dose escalation of gemcitabine up to 1000 mg/m2. Enzyme markers, blood co
Slide 4: Table 1. Treatment Regimen
Table 1. Treatment Regimen Cycle Day Chemotherapy Dose 1* 1 Gemcitabine 250 mg/m2 8 15 Gemcitabine 250 mg/m2 22 29 2 1 Gemcitabine 500 mg/m2 8 15 Gemcitabine 500 mg/m2 22 29 3 1 Gemcitabine 750 mg/m2 8 15 Gemcitabine 750 mg/m2 22 29 4 1 Gemcitabine 1000 mg/m2 8 15 Gemcitabine 1000 mg/m2 22 29 *Start
Slide 5: Pressure over Time
Pressure over Time 7 wo so catheter in Z artery z 40 E start infusion 4 second balloon up 10 BESSSRRIRSRSRRSRSRRRERSRR gee SESEZSEZERPEGESE REESE SES EE EES Tine THRE i 2 307 . vessel wall vessel RenovoCath vessel vessel wall
Slide 6: Splenic artery narrowing with RenovoCath isolation of the tumor region
Splenic artery narrowing with RenovoCath™ isolation of the tumor tumor impingement region with drug delivery
Slide 7: Table 2. Patient Characteristics
Table 2. Patient Characteristics Characteristic No. % Age, years Median 70 Range 51-84 Sex Male 9 45% Female 11 55% Stage of Tumor I 0 0 II 0 0 III 20 100% IV 0 0 Prior Treatment Yes 11 55% No 9 45% Prior Chemotherapy Only Yes 5 25% No 15 75% Prior Chemoradiation Yes 6 30% No 14 70% Prior Surgery Ye
Slide 8: Toxicity: Table 3. Toxicities (grade 3 and grade 4)
Table 3. Toxicities (grade 3 and grade 4) Grade 3 Grade 4 Toxicity No. of Patients % No. of Patients % Hematologic Neutropenia 3 15% 0 0 Thrombocytopenia 0 0% 0 0 Leukopenia 0 0% 0 0 Non-hematologic Bilirubin 0 0% 0 0 Hyperglycemia 0 0% 0 0 Elevated Liver Function (LFP) 0 0% 0 0 Elevated Pancreatic
Slide 9: Table 4. Serious Adverse Events
Table 4. Serious Adverse Events Parameter No. of Patients Vascular Visceral Arterial Dissection Requiring termination of further treatment 2 Continuing further treatment 1 Vascular access complication Hematoma (self-limited, conservative management) 1 Non-Vascular Pulmonary Distress 1 Sepsis 3 Gastr
Slide 10: Table 5. Efficacy: Tumor Response
Table 5. Efficacy: Tumor Response (clinical and or radiological progression), RECIST Criteria CT response, CA19-9 Parameter No. of Patients % Stable Disease 10 67% Progression 3 20% Partial Response 2 13% CA 19-9 Reduction 9 60% > 20% CA 19-9 Reduction 5 33%
Slide 11: Survival: RenovoCath treatment (>2 treatments)
RenovoCath treatment (>2 treatments): 43% survival 100 90 80 70 60 Survival (%) 50 43% survival 40 30 20 RenovoCath greater than 2 treatments – Average 4.4g/m2 of Gemcitabine (n=15) 10 0 0 5 10 15 20 25 Months post Initial Diagnosis 11
Slide 12: Survival: RenovoCath treatment (8 treatments)
RenovoCath treatment (8 treatments): 53% survival 100 90 80 70 60 Survival (%) 53% survival 50 43% survival 40 30 20 RenovoCath completing 8 treatments – Average 5.75g/m2 of Gemcitabine (n=9) 10 RenovoCath greater than 2 treatments – Average 4.4g/m2 of Gemcitabine (n=15) 0 0 5 10 15 20 25 Months pos
Slide 13: Survival: RenovoCath prior radiation
RenovoCath treatment (>prior radiation): 75% survival 100 90 80 75% survival 70 60 Survival (%) 53% survival 50 43% survival 40 30 20 RenovoCath prior chemoradiation therapy - Average 6.2g/m2 of Gemcitabine (n=7) RenovoCath completing 8 treatments – Average 5.75g/m2 of Gemcitabine (n=9) 10 RenovoCat
Slide 14: Table 6. Prior chemoradiation vs. others, clinical response
Table 6. Prior chemoradiation vs. others, clinical response: Median Survival, CA19-9 reduction, CT response Prior Chemoradiation All Others P value (n=5) (n=10) Median Survival 846 days 327 days P < 0.1 Survived more than two years post-diagnosis 4 1 p < 0.005 >20% CA 19-9 Reduction 3 2 P < 0.1 Cons
Slide 15: Survival: RenovoCath Effect
Survival: RenovoCath Effect + 15 months survival
Slide 16: Pre-Tx and Post-Tx Tumor size
Pre-Tx Tumor size: 2.8 x 3.3 x 4.1 Post-Tx Tumor size: 2.3 x 2.5 x 3.4
Slide 17: Trans-Arterial Micro-Perfusion
Trans-Arterial Micro-Perfusion Native tissue/vasculature + IA chemo Irradiated tissue/vasculature + IA chemo
Slide 18: Next Steps: RR3 Phase 3 Study Design
Next Steps: RR3 Phase 3 Study Design “Induction Phase” Locally IV Gem/ IV Gem/ Advanced PATIENT Abraxane Radiation Abraxane Pancreatic ENROLLMENT 2 cycles 1 cycle Cancer CT Stable Progression “Standard RANDOMIZE of care” IA Gem IV Gem/ 8 Treatments (bi- Abraxane weekly) 4 Cycles IV Gem/ IV Gem/ Abra
Slide 19: Summary
SUMMARY Intra-arterial delivery of gemcitabine using localized delivery catheter, RenovoCath, is safe provided: Patients with prior biliary stent/drain receive peri-op antibiotics IR training/support is necessary to avoid guide mediated vascular complications Early efficacy results of survival is en
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