9-20-2011 Islet Sciences Presentation - Blue
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9-20-2011 Islet Sciences Presentation - Blue

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Company presentation for Islet Sciences. Includes background on current standards of care for diabetes and presents the company approach.

Company presentation for Islet Sciences. Includes background on current standards of care for diabetes and presents the company approach.

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9-20-2011 Islet Sciences Presentation - Blue 9-20-2011 Islet Sciences Presentation - Blue Presentation Transcript

  • Islet Sciences Introduction - A Novel Cell TherapyProduct CompanyIslet Sciences is focused on providing the leading edge in transplantationtherapy for patients with type 1 diabetes with Islet Science-PTMPre-Clinical Studies have demonstrated Islet Sciences-PTM’s potentialclinical value for patients by 1. Reducing need for insulin 2. Achieving better glucose stability 3. Reducing problems with hypoglycemia (low blood sugar)Islet Sciences plans to submit its IND in Q1, 2012 followed by humanPhase I /IIA clinical trials. 2
  • We Intend to be the Leading Global Provider of a: - Safe - Effective - Physiologically Responsive “Therapy” For Type 1 Diabetic Patients, Worldwideislet cell (n.) - One of the endocrine cells making up the islets of Langerhans.islets of Langerhans - Irregular microscopic structures scattered throughout the pancreasand comprising its endocrine portion. They contain the alpha cells, which secrete thehyperglycemic factor glucagon; the beta cells, which secrete insulin, and whose degenerationis one of the causes of diabetes mellitus; and the delta cells, which secrete somatostatin. 3
  • Clinical Islet TransplantationJonathan R.T. Lakey, PhD “challenges of human islet transplantation” Challenges of human islet transplantation 4
  • Issues with the Current Standards of Care11/23/10 (Reuters) - More than half of Americans will have diabetes or beprediabetic by 2020 at a cost to the U.S. health care system of $3.35trillion if current trends go on unabated (source: United Health)Insulin injections do not address the major complications of Type 1Diabetes especially kidney, heart, nerve and eye disease.Islet transplantation (Edmonton protocol), while not a therapeuticopportunity, has shown proof of concept that Islet transplantation can besurrogate for pancreas transplantation.Transplant Islet cell therapy is indicated for Type 1 Diabetes that is difficultto control. Only 1,000 human Pancreas transplants are performed eachyear.Patients have to be maintained on immunosuppressive medication.Success is limited due to availability of Islet cells. 5
  • Excerpts from Scientific American : January 31, 2008It seems our porcine pals may also prove invaluable in the fight against type 1 diabetes.Researchers are experimenting with new ways of harvesting insulin-producing islet cellsfrom pigs and transplanting them into diabetes sufferers in the hope of one day reducingthe need for daily insulin shots…Pig insulin is a good candidate for xenotransplantation to humans because it differs fromhuman insulin by only a single amino acid. Although the Food and Drug Administrationhas approved porcine organ xenotransplants, it is still unclear how long these new isletscan remain functional in a human body, Hoffman says. “if they lasted six months to ayear,” he says, “you could have treatment at those intervals.” 6
  • Why Cell Therapy for Diabetes ? Insulin injections do not address the major complications of diabetes Proof of Concept for cell transplantation is well accepted Our technologies are designed to overcome remaining hurdles in the field Replacement Pancreas – Providing a physiologically base period of normal glycemia would be a major advance in the treatment modality for type 1 diabetes 7
  • Our Product: Islet Sciences – PTM {Patented Modification}• Alginate - a biocompatible biopolymer, specially designed for cell therapy • Allows nutrients (insulin, glucose, oxygen) to diffuse freely • Blocks antibodies, reduces immune system rejection 8
  • Previous Islet NOW Cell Lines Islet Sciences 9
  • Islet Sciences Novel Encapsulated IsletsA cell co-encapsulatedsynergistically with othertherapeutic agents. Four major patent initiatives covering ISLT tm 10
  • Islet Immunohistochemistry: • Beta cells (Insulin) • Alpha Cells (glucagon)Data in collaboration with Dr. Paul Johnson & Stephen Hughes 11
  • Proprietary Islet Maturation Day 0 Day 2 Day 5 Day 14 Day 7 12
  • Proprietary Islet Maturation 80000Islet Equivalents (2 piglet pan) 70000 ISM 3 60000 50000 ISM 2 40000 30000 ISM 1 20000 10000 0 Day 0 Day 1 Day 3 Day 4 Day 5 Day 7 Day 9 Day 14 • Novel piglet islet isolation protocol • Novel islet maturation culture media • New post encapsulation media 13
  • Minimally Invasive Transplant 14
  •  Progenitor Cell Therapy : www.progenitorcelltherapy.com  GMP Manufacturing of our Product NIH  Grants UC Irvine Medical Center Diakine : www.diakine.com 15
  • Islet Sciences Development Timeline Rodent Rodent Primate IND & Human Studies Studies Studies Trials (Phase Immune Immune Completed I / IIA) Deficient Competent2010 Islet Sciences MilestonesAcquired Key TechnologiesClinical trial sites identifiedInitial audits of harvest, isolation and process facilitiesIND submission projected Q1/2012Human Phase I/IIA clinical trials initiated in Q2/2012 16
  • Our First Patient Population : Diabetics with End-StageRenal Disease• Diabetes is leading cause of ESRD • Causes 44% of new cases• 100,000 new cases of ESRD reported annually• 20-40% of type 1 diabetics develop ESRD by age 50• In the absence of adequate treatment by dialysis or transplantation, these patients die• 1,000,000 persons living with kidney transplant and diabetes 17
  • Islet-Kidney: Transplant Benefits 100  Extended kidney graft and patient Pancreas & Kidney 90 survival Transplant * 80  Reduction of long- Kidney Transplant term diabetes Plus Islet Therapy 70 complications Kidney Transplant 60  Lower long-term with Ongoing DM Dialysis with 50 healthcare costs Ongoing DM 40  Quality of life improvement 30 0 1 2 3 4 5 6 years * 1000 performed annually 18
  • Board of DirectorsGeorge J. Todaro, MD A renowned research scientist and medical doctor, Dr. Todaro co-authored the groundbreaking“Oncogene Theory” while at the National Institute of Health (NIH) in Bethesda, Maryland in1969.The “Oncogene Theory” would became one of the foundations for future cancer research. In theearly 90s, as scientific director at Seattle-based PathoGenesis, he developed a treatment that hassaved the lives of countless cystic fibrosis patients. And, more recently, his focus has turned tobiotechnology, where he is working to find ways to increase the world’s food supply. Todaro canalso add to his list of accomplishments that he was elected to the National Academy of Sciences,was a professor and department head at the University of Washington, holds over 20 patents, andwas named one of the Ten Outstanding Young Men of America in 1970. Joel D. PerlinAfter his graduation from San Diego State in 1969, he began to pursue a career in the gold andrare coin industry. He has since become a renowned professional numismatist and a recognizedexpert in international gold trade and advisory. Mr. Perlin combines his coin expertise with a keeninsight into factors affecting the precious metals trade, resulting in highly successful and lucrativegold investment market trading for his clients. For more than 40 years, he has been instrumental indeveloping personalized investment portfolios using both rare coins and U.S. gold coins for highnet worth investors, corporate pension plans and financially private investors.John Steel, Chairman, Interim CEO 19
  • Corporate ManagementJohn Steel, Chairman, Interim CEOInternational Scientific Advisory BoardChair - Dr. Jonathan Lakey, Head of Research, Dept of Surgery, UCI, Irvine,CaliforniaDr. Paul Johnson, President of IPITA, Professor of Surgery, Oxford, EnglandDr. Steven Paraskevas, Professor of Surgery, McGill University,Montreal, QuebecDr. Miguel Riella, Professor of Transplant Surgery, Curtubia, BrazilDr. Jerry Nadler, Chair Endocrinology, EVMU, Virginia 20
  • Corporate ManagementJohn Steel, Chairman, Interim CEOMr. John Steel is the President & CEO of Islet Sciences. Mr. Steel brings over twenty years ofsenior management and investment experience in the healthcare services and biotechnologysector. In 1998, Mr. Steel founded MicroIslet, the firm that pioneered and developed thetechnology that comprises Islet Sciences, and served as its Chairman and Chief Executive Officefrom September 1998 to 2002. From January 1996 to December 1997, Mr. Steel was ChiefExecutive Officer of AKESIS Pharmaceuticals, Inc., a company that developed a patentedtreatment for insulin resistance for Type II diabetes. From January 1987 to June 1990, Mr. Steelserved as the Vice President of Defined Benefit Inc., a company he founded in 1986 that providedfinancial services to health care professionals. After Defined Benefit Inc., Mr. Steel was an activeinvestor and consultant within numerous areas including early-stage biotechnology and devicecompanies through Steel Management. Mr. Steel himself is diagnosed with Type 1 JuvenileDiabetes and is actively involved in fund raising for various diabetes research-related charities. Mr.Steel has recently chaired panels regarding the future of diabetes for the California InsuranceCommissioner. Mr. Steel is also a noted speaker on the topic of diabetes - including itsmanagement, economics, and future opportunities for improvement in therapeutic modalities. Mr.Steel received his M.B.A. degree with an emphasis in finance from the University of SouthernCalifornia and a Bachelor of Arts degree from Dartmouth College. 21
  • Scientific Advisory BoardJonathan Lakey, Ph.D. - MSMDr. Jonathan Lakey has had a long history in cell and tissue transplantation with a focus ondiabetes and islet transplantation. He graduated from the University of Alberta (BSc, MSc, PhD)and received postdoctoral training in Indianapolis and Seattle before returning to establish hisresearch program at the University of Alberta. He is a former Director of the ComprehensiveTissue Bank. His contributions and partnership with Dr. James Shapiro led towards theimprovement of islet isolation techniques and the development of the “Edmonton Protocol” forpatients with Type 1 diabetes, a recognized major advancement in the treatment of diabetes.He has been awarded research grants and awards for diabetes and transplantation researchfrom the Alberta Heritage Foundation for Medical Research (AHFMR), Canadian DiabetesAssociation and the Juvenile Diabetes Foundation International (JDFI). Dr. Lakey is widelysought after as a speaker in the field of diabetes islet transplantation and regulatory standardsof cell and tissue transplantation. He has been widely published with over 250 referred scientificpapers, 26 book chapters, submitted over 500 scientific abstracts, and has recently published atechnical book on islet isolation. Among his proudest achievements, Dr. Lakey and his teamhave successfully trained over 40 islet transplant centers worldwide in replicating the EdmontonProtocol, resulting in diabetic patients being freed from exogenous insulin injections. He sits oneditorial boards of several diabetes and transplantation journals, reviews manuscripts forseveral journals, and has served as a Councilor for Cell Transplant Society. Currently, Dr. Lakeyis the Director of Research and Associate Professor of Surgery at the University of California,Irvine. He recently accepted the position of Director of the Clinical Islet Program at theUniversity of California, Irvine. 22
  • Scientific Advisory BoardPaul Johnson, MBChB MD FRCS, President, IPITADirector of Oxford Islet Transplant Programme and Professor of Paediatric Surgery, University of Oxford. Dr.Johnson also currently serves as President of the International Pancreas and Islet Transplant Association.Paul Johnson qualified in medicine from the University of Leicester and subsequently trained in GeneralSurgery in Leicester and Derby, followed by higher surgical training in Paediatric Surgery in Oxford, Melbourne,and Great Ormond Street Hospital in London. Between 1993 and 1996 he was a Research Fellow in theDepartment of Surgery at the University of Leicester, where he undertook a project on the Isolation of HumanIslets of Langerhans for Pancreatic Islet Transplantation. This led to a Doctorate of Medicine and started hisongoing interest in the field of Islet Transplantation for reversing Type 1 Diabetes. He was awarded a HunterianProfessorship from the Royal College of Surgeons of England for this research in 1998. In 2002, Mr. Johnsonwas appointed Director of the Islet Transplant Programme in Oxford. He is currently Chairman of the Researchdivision of British Association of Paediatric Surgeons Research and Clinical Effectiveness Committee, Founderof the UK Academic Paediatric Surgeons Group and Co-Secretary of the International Pancreas and IsletTransplantation Association. He is also Clinical Tutor at St. Edmund Hall. He has an active research group andhis research interests include ways of optimizing the current methods used for islet isolation with particularreference to pancreatic structure and collagenase, and the developmental biology of the pancreas and foregutwith particular relevance to the use of adult stem cells as an alternative source of islet tissue fortransplantation. In addition to islet transplantation, his clinical interests include the neonatal and paediatricpancreas (endocrine and exocrine), as well as other aspects of paediatric surgical gastroenterology. 23
  • Scientific Advisory BoardSteven Paraskevas, MD PhDDr. Paraskevas is a transplant surgeon at McGill University Health Centre, specializing inpancreas and kidney transplantation. Originally from Winnipeg, Dr. Paraskevas obtained a BA inBiology at Harvard University in 1988, and obtained his MD and completed General SurgeryResidency at McGill. During that time, he also studied mechanisms of cell death in transplantedhuman islets, completing a PhD in Experimental Surgery at McGill in 2003. Based on this work,he also earned the Scientific Trainee Award of the Canadian Diabetes Association in 1997. Afterresidency, he completed a two-year fellowship in abdominal solid-organ transplantation at theUniversity of Minnesota, where he was also involved in the clinical islet transplant program underDr. Bernhard Hering. He returned to McGill in 2002 as Assistant Professor in Surgery, andmember of the multi-organ transplant program. He is currently Director of the Pancreas and IsletTransplant Program and of the Human Islet Isolation Laboratory at McGill. His current researchfocuses on mechanisms of cell survival during ischemia and the effect of metabolic andinflammatory stress on engraftment of human islets. He is a Councillor-at-large of the CanadianSociety of Transplantation and Chair of the Cell Transplant Committee of the American Societyof Transplant Surgeons. 24
  • Scientific Advisory BoardMiguel Riella, MD, PhDDr. Riella is a graduated of Federal University of Parana in Curitiba Brazil and has undertakenhis post-graduate training in the United States, first in Internal Medicine, Residency at MountSinai Hospital in NYC and then Research Renal Fellowship at the University of Washington inSeattle, USA. His main interest has been in dialysis, particularly peritoneal dialysis and nutritionin uremia. More recently his research work has been concentrated in the relationship ofinflammation, uremia, nutrition and cardiovascular complications. As part of his new RDHResearch Center (Renal, Diabetes and Hypertension Research Center) he has recentlyestablished the Islet Cell Laboratory for cell transplant in diabetic patients. Dr. Riella haspublished several books in Portuguese and Spanish language in the area of Nephrology andNutrition. He is a member of the executive committee of the International Society of Nephrologyand is the Chairman of the new ISN-Interventional Nephrology Committee. He is a member ofthe editorial board of several medical journals, is the Associate Editor of HemodialysisInternational and the co-editor of the Portuguese version of Kidney International. 25
  • Scientific Advisory BoardJerry L. Nadler, MDDr. Nadler is Professor and Chairman of Internal Medicine, the Harry H. Mansbach EndowedChair in Internal Medicine and Director of the Strelitz Diabetes Center at Eastern VirginiaMedical School. Dr. Nadler is also the Scientific Founder of Diakine, a seed stage companydeveloping therapies for type 1 and type 2 diabetes and related complications. Dr. Nadler is alsoa Pfizer Visiting Professor in Diabetes. Dr. Nadler has been a member of a Special AdvisoryCommittee on Type I Diabetes with the director of the National Institutes of Health DiabetesInstitute. Dr. Nadler was also the Associate Director of the NIH-funded Diabetes EndocrinologyResearch Center at the University of Virginia. Dr. Nadler has research funding from the JuvenileDiabetes Foundation, The Ella Fitzgerald Charitable Foundation and the Iacocca Foundation. Heis a standing member of the ADA and NIH grant review committees. 26
  • Science SummaryProprietary Methods for Isolating and Encapsulating Proof-of-concept accepted GMP manufacturing Absence of safety signals Minimally invasive transplant procedure Human Clinical Trials planned for Q2/2012 27
  • Business Strategy• Focus on approval of Islet Sciences - PTM from FDA for Type 1 Diabetes with ESRD patients as lead indication.• Establish infrastructure to provide scale and logistics for expansion of clinical trials and future market entry.• Approach EU regulatory agency (EMEA) to prepare for EU approval and geographical expansion for Islet Sciences-PTM.• Engage with major players to partner for trial expansion and market entry.• Explore and partner for other therapeutic indications for Islet Sciences proprietary technology.• Pursuit of complementary technologies will provide strategic advantage.• Exit is anticipated through potential acquisition by a major pharma. 28
  • Business Summary Large growing market / Unmet medical need Significant barriers to entry Acquired Microislet assets in Chapter 7 proceedings Leverage of Microislet’s time and $70M of development expense Change in investor base from 3,000 to 30 Merger into public company September, 2011 New IP and patent filings 29