PharmaCyte Biotech, Inc. · NASDAQ:PMCB
PharmaCyte Biotech — BIO International Convention 2017
21 slides from PharmaCyte Biotech's conference presentation, June 2017
Slide 1: PharmaCyte Biotech - BIO International Convention
PHARMACYTE BIOTECH oes International =) Bl Convention The Global Event for Biotechnology
Slide 2: Safe Harbor Statement
Safe Harbor Statement • This document may include statements that constitute “forward looking statements,” which are often characterized by the terms “may,” “believes,” expects” or “anticipates” and do not reflect facts. • Forward-looking statements involve risks, uncertainties and other factors tha
Slide 3: Cellular Platform Technology
Cellular Platform Technology Encapsulate Genetically Modified Live Cells to Treat Diseases • Cancer: o Encapsulate genetically modified live cells that convert a prodrug from its inactive form to its cancer killing form o Encapsulated cells are implanted near the site of the tumor; low dose chemothe
Slide 4: Cell-in-a-Box Capsules
Cell-in-a-Box® Capsules Encapsulation Material • Capsules are made of bio-inert material (cellulose/cotton) • Capsules have pores for nutrient and waste transfer • Pores are too small for immune system cells to enter or encapsulated live cells to leave • Long-term (5+ years) frozen storage of encaps
Slide 5: Product Pipeline
Product Pipeline Pancreatic Cancer: Encapsulated live cells converting Preclinical Phase 1 Phase 2 Phase 3 ifosfamide – antitumor effectiveness Abdominal Cancers: Encapsulated live cells converting Preclinical Phase 1 Phase 2 Phase 3 ifosfamide – delaying malignant ascites fluid production and accum
Slide 6: Problem: Pancreatic Cancer
Problem: Pancreatic Cancer Aggressive Cancer with Poor Prognosis • Third leading cause of cancer-related deaths in the western world • Overall survival rate is 8% • Expected pancreatic cancer patients in 2017: U.S. >53,000; Europe >80,000 • Approximately 72% die within the first year of diagnosis •
Slide 7: Solution: Targeted Chemotherapy
Solution: Targeted Chemotherapy Cell-in-a-Box® + Ifosfamide Targeted Chemotherapy • Ifosfamide at “normal dose” has shown success in treating testicular cancer, but cannot be used at normal dose due to severe toxicity • Cell-in-a-Box® capsules containing genetically modified live cells that produce
Slide 8: Targeted Deployment and Activation
Targeted Deployment and Activation • Capsules containing live ifosfamide-activating cells are implanted in the blood vessels leading to the pancreas tumor • Low dose ifosfamide is given intravenously • Ifosfamide is converted to its cancer-killing form by the encapsulated live cells Blue Arrow: Ifos
Slide 9: Mechanism of Action
Mechanism of Action Inactive ifosphamide “prodrug” Pancreas “Activated” ifosfamide Immune system cells molecules tumor too large to enter cancer killing in-situ capsule Single capsule containing ifosfamide-activating live cells 9
Slide 10: Placement of Encapsulated Cells
Placement of Encapsulated Cells A. Angiography of blood vessels to the pancreas B. Insertion of catheter into the pancreas blood vessel (arrow) C. Injection of microcapsules D. Angiography shortly after capsule implantation (arrow) Blood supply to the pancreas is not impeded by the capsules 10
Slide 11: Phase 1/2 Trial
Phase 1/2 Trial Trial Design and Endpoints • Fourteen patients were treated with only two courses of ifosfamide at 1/3 (1 g/m2) of the dose normally used to treat other forms of cancer • Patients with advanced, inoperable pancreatic cancer were treated in a single- arm (no comparator arm) trial at a
Slide 12: Previous Trials in Pancreatic Cancer
Previous Trials in Pancreatic Cancer Phase 1/2 Clinical Trial with Two Courses of Low Dose Ifosfamide • Median survival: gemcitabine = 5.7 months vs. Cell-in-a-Box® + ifosfamide = 10 months • Percentage of 1-year survivors: gemcitabine = 18% vs. Cell-in-a-Box® + ifosfamide =36% • Treatment-related s
Slide 13: Survival Results of Trials
Survival Results of Trials Kaplan–Meier Curves Describing Patient Survival 14 Patients 13 Patients 36 Patients • Phase 1/2 clinical trial in green boxes • Phase 2 clinical trial in blue triangles • Age and disease stage matched historic control group receiving the best available standard care in red
Slide 14: Pancreatic Cancer Treatment Options
Pancreatic Cancer Treatment Options Current Standard of Care is Combination of Abraxane® + Gemcitabine • Combination approved by FDA in September 2013 • Increased median survival by 1.8 months as compared to gemcitabine alone • Increased the percentage of one-year survivors from 22% with gemcitabine
Slide 15: Pivotal Trial to Address Unmet Medical Need
Pivotal Trial to Address Unmet Medical Need PharmaCyte Addressing Critical Unmet Medical Need • A critical unmet medical need exists for patients with advanced pancreatic cancer whose tumors are locally advanced, non-metastatic and inoperable but no longer respond to Abraxane® + gemcitabine • These
Slide 16: Pivotal Trial Design Oncologists
Pivotal Trial Design Oncologists Dr. Daniel Von Hoff Dr. Manuel Hidalgo Dr. Matthias Löhr 16
Slide 17: Pivotal Trial Design Oncologists (cont'd)
Pivotal Trial Design Oncologists (cont’d) Dr. Daniel Von Hoff • The world’s leading oncologist in the development of drugs to treat pancreatic cancer • Involved in clinical trials of more than 200 anticancer and biologic drugs • Conducted early clinical trials for most of the cancer agents approved
Slide 18: Pivotal Trial Design
Pivotal Trial Design Elements of Trial Design • Design: Trial will be two-armed • Location: Trial will be conducted in the United States and Europe • Objective: Trial is designed to show Cell-in-a-Box® + low-dose ifosfamide can serve as an effective and safe consolidation chemotherapy for patients w
Slide 19: Pivotal Trial Design (cont'd)
Pivotal Trial Design (cont’d) Elements of Trial Design (cont’d) • Eligibility (cont’d): Patients must have been treated with Abraxane ® + gemcitabine for 4-6 months and their tumors no longer respond to this therapy • Randomization: Patients will be randomized into two groups. One group will receive
Slide 20: Trial Preparations
Trial Preparations Manufacturing Capability • cGMP facility successfully audited and deemed ready for production • Production of trial material being validated • Trial material expected to be available Q3 2017 Trial in United States and Europe • Dr. Manuel Manuel Hidalgo selected as Principal Invest
Slide 21: Questions?
Questions? Answers Thank you 21
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