A Clinical Stage Drug Company Developing Polymolecular Therapeutics
- Slides: 14
A Clinical Stage Drug Company Developing Polymolecular Therapeutics For The Oncology, Neurology And Orthopedic Markets Jonathan Pirkl, VP of Business Development jonathanp@unitedcannabis. us 813 -438 -9998
THE PROBLEM OUR SOLUTION Most diseases have multifactorial causes and hence are driven by multiple factors. This helps to explain marginal outcomes and the high rate of failure in new drug development. . Involves identification of novel combinatory targets based on preclinical and clinical efficacy data using our Polymolecular Botanical Drug platform COMBINATORIAL TARGETING At the core of our platform is the conviction that unlike many pharmaceuticals, botanical compounds are heterogeneous with multiple active components that are able to modulate multiple mechanisms through COMBINATORIAL TAGETING to combat disease progression.
Timeline Technology developed at University of Florida Patents filed in USA & internationally (composition of matter and use claims) Incorporated in Delaware in November 2012 Preclinical phase completed Exclusive, worldwide license to the technology acquired by Prana Therapeutics, Inc. in 2017 Clinical studies begin 2018 Over 600 K raised: grant & research contract, founders
Epidiferphane™ Proprietary blend of 3 botanical compounds developed & owned by Prana Therapeutics 1 2 3 Catechin from green tea Curcumin [potent anti-inflammatory] Sulforaphane [nature’s most potent anti-oxidant regulator] Supplement Epidiferphane™ Marketing Opportunities Drug
R & D PROGRAM DRUG DEVELOPMENT PROGRAM Preventing Chemotherapy Side-effects 2018 2019 2020 2021 Phase I/II Phase III 2022 Inflammatory Disease Back Pain & Arthritis Cancer Phase II High Grade Glioma Pre-clinical Testing Clinical Testing Phase III
Current Market Size # Patients per year Preventing Chemotherapy Side-effects Annual Sales 650 K $12 B Back Pain 91 M $17 B Arthritis 46 M $15 B Notes Largely an unmet need, with no therapies to prevent Inflammatory Disease Cancer High Grade Glioma 23 K $0. 4 B Plethora of treatments, many have significant side effects Our approach is meant as an adjunctive treatment used together with standard of care
Product Development Workflow DISCOVERY: Tissue Culture & Animal Models are used to Identify Poly molecular Therapeutics STAGE 01 First Products are Engineered for the Supplement Market • Based on preclinical and limited clinical data • PMBS [Poly. Molecular Botanical Supplement] PMBS Undergo Rigorous FDA Clinical Trial Evaluation Intended for New Drug Approval [NDA] • PMBD [Poly Molecular Botanical Drug] STAGE 03 STAGE 02 FDA Approved PMBD will be Developed into Synthetic Drugs Based on Successful • PMSD [Poly. Molecular Synthetic Drug]
Attenuating the side effects of Chemotherapy NO THERAPIES EXIST to prevent these side effects which are often treatment limited, diminish treatment efficacy & reduce quality of life. Each year in the USA there approximately: 1. 6 M 650 K New Cancer Diagnosis New Chemotherapy Pits Over 90% of chemotherapy pts. experience at least one of the following negative side-effects: Low red blood cells Chemotherapy Induced Peripheral Neuropathy Neutropenia Memory Problems Low white blood cells Chemo fog or Chemo brain Anemia
Attenuating the side effects of Chemotherapy Anemia Neutropenia Epidiferphane™ when given with chemotherapy prevents 4 major negative side effects of chemotherapy Neuropathy Neural stem cells
Inflammatory Disease Back pain and arthritis 75% of responders saw improvement with an average improvement of 50% 75% of responders saw improvement with an average improvement of 45% 100% of responders saw improvement with an average improvement of 60% How often were you in a bed or chair most or all of the day? Did you have trouble doing vigorous exercise? How often do you have severe pain from your arthritis?
Inflammatory Disease Back pain and arthritis 75% of responders saw improvement with an average improvement of 50% 75% of responders saw improvement with an average improvement of 60% 75% of responders saw improvement with an average improvement of 50% How often does morning stiffness last for more than 1 hour? How often does the pain make it difficult to sleep? How often have you felt tense or high strung?
Cancer High Grade Glioma Epidiferphane™ when combined with a low carb [LC] diet has been demonstrated to: NO EFFECTIVE THERAPIES EXIST to treat Stage IV gliomas or Glioblastoma • Each year in the USA there approx. 80 K new brain cancer diagnoses • The most common type, Glioblastoma, has a survival diagnosis of approximately 12 months. • • • Increase survival of human tumors in a rodent Work synergistically with chemotherapy Sensitize chemotherapy resistant tumors to standard of care drugs Epidiferphane™ when combined with a low carb diet doubles mean life expectancy
OUR PARTNERS CLINICAL TRIAL SITES
FOUNDERS MANAGEMENT BOARD OF DIRECTORS Brent Reynolds, Ph. D. Prof Neurosurgery, University of Florida Dennis Steindler, Ph. D. Director Neuroscience and Aging Lab, Tufts University Loic Deleyrolle, Ph. D. Res Asst Prof, University of Florida President Courtney Simmons, M. Ed. SVP of Program Management Founder & President Prana Therapeutics Earnie Blackmon CEO United Cannabis John Walsh Ben Griffith, B. Sc. Project Manager CFO United Cannabis
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