MicroIslet Announces New Scientific Advisory Board.
SAN DIEGO -- MicroIslet Inc., (OTCBB: MIIS, http://www.microislet.com), a biotechnology company engaged in the development and commercialization of cell transplantation therapies for diabetes, today announced the formation of a new Scientific Advisory Board. The Company named John B. Buse, M.D., Ph.D., David W. Scharp, M.D., Christopher L. Marsh, M.D., F.A.C.S, Bassam Damaj, Ph.D., Miguel Carlos Riella, M.D., Ph.D., and John Logan, Ph.D. as members. The new Scientific Advisory Board will assist MicroIslet in the development of its MicroIslet-P(TM) product for the treatment of type 1 diabetes.
"I'm honored by the enthusiasm for MicroIslet's approach shown by all of our distinguished advisors," said Michael J. Andrews, MicroIslet's Chief Executive Officer. "They bring a wide range of experience applicable to our development plans. This new Advisory Board is the last step in our establishment of the internal and external organization necessary to advance our MicroIslet-P(TM) product toward an IND application planned for the third quarter of 2008, and the subsequent initiation of MicroIslet's "first in man" U.S. clinical trials. MicroIslet's team includes an outstanding internal organization, top industry consultants, a relationship with Progenitor Cell Therapy for cGMP manufacturing, an exclusive supply arrangement with FIOS Therapeutics, Inc. for our designated pathogen-free pig supply, and now this exceptional line up of key scientific advisors."
About MicroIslet's Scientific Advisors
John B. Buse, M.D, Ph.D.
Dr. Buse is the President for Medicine and Science at the American Diabetes Association and a board member of the Carolinas Affiliate of the American Association of Clinical Endocrinologists. He has received numerous awards and honors, including citation in Best Doctors in America since 2001.
Dr. Buse received his medical degree and PhD from Duke University in Durham, North Carolina before training in internal medicine and endocrinology at the University of Chicago. He is currently a professor at the University of North Carolina School of Medicine in Chapel Hill, North Carolina where he serves as the Chief of the Division of Endocrinology.
Dr. Buse has a diabetes practice located at UNC as well as at the Salem Center in Winston-Salem, North Carolina. His research interests focus on developing prevention and treatment strategies for type 1 diabetes, type 2 diabetes and their complications. He has authored more than 100 publications and is involved in numerous multicenter clinical trials, most prominently the National Heart Lung and Blood Institute's ACCORD (Action to Control CardiOvascular Risk in Diabetes) study for which he serves as Study Vice-Chair and the National Institute for Diabetes Digestive and Kidney Disease's STOPP-T2D (Studies to Treat Or Prevent Pediatric Type 2 Diabetes) study. He serves on the Data Safety Monitoring Board or Steering Committee for NIH and international studies such as NAVIGATOR, ORIGIN, IRIS, FREEDOM and NASH CRN. Dr. Buse is active in a number of national teaching efforts focusing on graduate medical education as well as CME including programs.
David W. Scharp, M.D.
Dr. Scharp trained and worked at Washington University School of Medicine, St. Louis, MO, as an academic surgeon and researcher in islet transplantation for nearly 30 years, producing over 200 publications with continuous NIH (National Institutes of Health) and JDRF (Juvenile Diabetes Research Foundation) funding and 13 patents to date.
Collaborative studies with the late Paul E. Lacy, MD, PhD, pioneered much of the early progress in islet transplantation. Dr.'s Scharp and Lacy were also co-founding scientists of Cytotherapeutics in 1989 with Dr.'s Aebischer and Galetti and completed a clinical trial of encapsulated human islets in 1993.
Dr. Scharp serves as Executive Vice President and Chief Medical Officer for Novocell, Inc., a Company developing conformal PEG coatings of human islets as an allograft (human to human) product for diabetics.
In 2006, Dr. Scharp founded Prodo Laboratories, Inc. that focuses on delivering high-quality products and services to the diabetes research community. In addition, he founded Invenio Institute, a not-for-profit California public benefit company focused on performing diabetes research.
Dr. Christopher L. Marsh, M.D., F.A.C.S.
Dr. Marsh is the chief of the Organ Transplantation Service in the Division of General Surgery & Organ Transplantation and Co-Director of the Center for Organ and Cell Transplantation at Scripps Green Hospital. Previously, Dr. Marsh was associate professor of surgery and urology, Director of the Kidney/ Pancreas Transplantation Program and associate head of the Division of Organ Transplantation at the University of Washington Medical Center in Seattle. Dr. Marsh attended medical school and completed a urologic surgery residency at Loma Linda University in Loma Linda, California, followed by a transplantation fellowship at the Mayo Clinic in Rochester, Minnesota. Dr. Marsh is certified by the American Board of Urology and is approved by the American Society of Transplant Surgeons. He is a member of the American College of Surgeons, American Society of Transplant Surgeons, American Society of Transplant Physicians, International Pancreas and Islet Transplant Association, and American and International Liver Transplant Societies and American Urological Association. He has also served as president of the Urologic Society for Transplantation and Vascular Surgery. He currently chairs the medical advisory committee to LifeSharing, is a member of the UNOS liver, intestine, and pancreas committee and is the chair of the regional review board for liver exceptions for Region V of UNOS. Dr. March has written more than 100 articles, chapters or abstracts and has held various positions on national and regional transplantation and organ procurement committees. Dr. Marsh's research activity includes clinical trials using new immunosuppressive drug regimens in liver and kidney transplants, pioneered steroid-free immunosuppression in organ transplantation and helped initiate new protocols in islet transplantation for the treatment of insulin requiring diabetes. He has expertise in liver, kidney, pancreas and pancreatic islet transplantation.
Bassam Damaj, Ph.D.
Dr. Damaj is President and Chief Executive Officer of Bio-Quant, Inc., a company that seeks to translate scientific discoveries into safer, more effective treatments for people with immune and other life threatening diseases. Before joining Bio-Quant, Dr. Damaj served as President and CEO of BioSignature Diagnostics, Inc. He also served as the Group Leader for the Office of New Target Intelligence and a Group Leader for multiple immunological and inflammatory disease programs at Tanabe Research Laboratories USA, Inc. Previous appointments included serving as a senior scientist and a member of the senior staff board of the drug discovery department at New Jersey-based Pharmacopeia Inc. He also was a visiting scientist at Genentech Inc., Pfizer Inc. and the NIH (NIAID). Dr. Damaj is the inventor on over 12 patents and has authored numerous peer reviewed publications. Dr. Damaj has also been a consultant to General Atomics, Diazyme, Genentech, Primedica, Celltek Biotechnologies, and Virocell. He is the co-founder of Celltek Biotechnologies, Biosignature Diagnostics and Mina Holdings. Dr. Damaj is the inventor of the AMT technology that won a U.S. Congress award for the Anthrax Mulitplex Diagnostic Test.
Miguel Carlos Riella, M.D., Ph.D.
Recently, Dr. Riella established an Islet Cell Lab at the Catholic University and has performed the first islet cell transplant in humans in southern Brazil.
Dr. Riella is Professor of Medicine at two institutions: the Evangelic School of Medicine and the Catholic University of Parana. He is Chief of Nephrology at the Evangelic University Hospital. Dr. Riella founded the Pro Renal Foundation of Brasil (www.pro-renal.org.br), a non-for profit organization dedicated to patient assistance, education and research. More than 1800 patients are currently assisted by the Foundation. Dr. Riella is also the past president of the Brazilian Society of Nephrology and served on the Council of the International Society of Nephrology (ISN). He is a member of the Board of Directors of the International Federation of Kidney Foundations and will serves as the IFKF President for the period of 2009-2011. Dr. Riella is a member of the National Academy of Medicine in Brazil.
Dr. Riella is Board Certified in Internal Medicine by the American College of Physicians and Fellow of American College of Physicians-FACP 1998.
After graduation from medical school Dr. Riella did his Residency in Internal Medicine at The Mount Sinai Hospital in New York from 1970-73 and a Renal Research Fellowship at the University of Washington in Seattle (1973-75) under the supervision of Dr. Belding H. Scribner, a pioneer of chronic hemodialysis.
Dr. Riella organized the first Nephrology Division at the Evangelic University Hospital in Curitiba, Brasil. He helped start various other initiatives at the hospital such as the hemodialysis and kidney transplant programs.
In 1996 Dr. Riella received the Distinguished International Medal of the National Kidney Foundation-USA and he is an honorary member of numerous scientific societies.
John Logan, Ph.D.
Dr. Logan is a Founder and serves as Chairman, President and CEO of Fios Therapeutics Inc. (FIOS). Immediately prior to the formation of FIOS, Dr. Logan was a management consultant to the biotechnology industry and his major projects included work on the use of stem cells in cardiac disease, development of novel anti-virals for the treatment of HIV and as an advisor to Mayo Medical Ventures. Previous to that Dr. Logan was responsible for all of the activities of Nextran, Inc., a division of Baxter Healthcare. Nextran was focused on the development of genetically modified animals for use in xenotransplantation. As part of the activities of Nextran, Dr. Logan managed the world's first FDA cleared clinical trial of genetically modified organs for the treatment of patient's in fulminant hepatic failure. Before Nextran Dr. Logan was Chief Scientific Officer of DNX Corporation, the first commercial enterprise devoted to the development of biomedical and pharmaceutical applications of transgenic animal technology. Dr. Logan started his career in the biotechnology industry as a senior scientist at American Cyanamid Corporation. He holds a BSc (Hons) and PhD in biochemistry from the University of Glasgow and did post-doctoral training at Princeton University.
About MicroIslet, Inc.
MicroIslet is a biotechnology company engaged in the research, development, and commercialization of patented technologies in the field of transplantation therapy for patients with insulin-dependent diabetes. MicroIslet has licensed several technologies from Duke University for isolation, culturing, storage, and microencapsulation of insulin-producing islet cells from porcine sources. The Company believes that these technologies, and other proprietary methods developed in-house, are significant advances in the field of transplantation. MicroIslet is planning human clinical trials in the U.S., and exploring possible trials abroad. MicroIslet's ultimate goal is to offer cell transplantation therapies for diabetic patients worldwide.
The Company's lead product, MicroIslet-P(TM), consists of microencapsulated porcine islets for implantation into the abdominal cavity using a minimally invasive procedure. Microencapsulation involves surrounding islet cells with formulations of a highly biocompatible, ultra-pure biopolymer, called alginate, or other similar biocompatible polymers. The alginate coating allows insulin, glucose, oxygen and other nutrients to diffuse freely, while blocking antibodies and reducing the patient's immune response to the implanted islet cells. It is hoped that MicroIslet-P(TM) will provide physiologic and self-regulating blood glucose control, thus reducing the need for insulin injections or infusions and constant blood glucose monitoring. The long term complications associated with type 1 diabetes, such as peripheral neuropathies, heart and kidney disease, and skin disorders, may be mitigated by the tighter blood glucose control that would result from such a product.
Additional information about MicroIslet can be found at http://www.microislet.com.
Except for the historical information contained herein, the matters set forth in this press release are forward-looking statements within the meaning of the "Safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially, including MicroIslet's working capital deficit, which includes a substantial amount of indebtedness which is matured and due on demand; MicroIslet's need to raise substantial additional funds in order to fund its new strategy and continue as a going concern; the risks and uncertainties inherent in medical treatment discovery; development and commercialization; the risks and uncertainties associated with MicroIslet's early stage xenotransplantation technologies; the risks and uncertainties of governmental approvals and regulation, including foreign government approvals for clinical trials outside the United States; dependence on a sole source supplier of animal parts and a sole source manufacturer of encapsulated islets for pre-clinical and clinical studies; the risks that MicroIslet's competitors will develop or market technologies or products that are more effective or commercially attractive than MicroIslet's products; and other risks detailed from time to time in MicroIslet's most recent filings with the Securities and Exchange Commission. These forward-looking statements speak only as of the date hereof. MicroIslet disclaims any intent or obligation to update these forward-looking statements.