-- Board to Assist Clinical Development Strategy for Autologous Monocyte-derived Islet Transplantation --
THE WOODLANDS, Texas -- Opexa Therapeutics, Inc. (NASDAQ:OPXA), a company involved in the development and commercialization of cell therapies, today announced the formation of a Clinical
The CAB, which includes key opinion leaders in diabetes treatment and surgery, is comprised of Charles Brunicardi, M.D., F.A.C.S., Chairman of the Michael E. DeBakey Department of Surgery at Baylor College of Medicine in Houston; John Goss, M.D., Professor of Surgery and Chief of the Division of Abdominal Transplantation and Hepatobiliary Surgery in the Michael E. DeBakey Department of Surgery at Baylor College of Medicine; Dale Hamilton, M.D., Attending Physician and Section Chief of the Department of Diabetes, Obesity and Lipids at The Methodist Hospital in Houston and Saundra Hendricks, M.S., A.P.R.N., BS-ADM, Director of the Diabetes Nurse Practitioners Program at The Methodist Hospital.
David McWilliams, chief executive officer of Opexa Therapeutics, commented, "We are proud to have such a distinguished Clinical Advisory Board with some of the world's most respected and experienced experts in the fields of endocrinology, surgery, islet transplantation and clinical design, who will work together to advance our personalized therapy to benefit patients suffering with diabetes."
The CAB will play an important role in guiding the upcoming phase 1 clinical studies in the use of autologous monocyte-derived islets (MDIs) in transplantation therapy to replace pancreatic beta-islet clusters that have been depleted in diabetic mellitus patients. The derivation of MDIs from patient's peripheral blood monocytes promises to be a safe and effective alternative to current methods of using allogeneic derived beta-islet clusters in transplantation therapy.
"We have accomplished a great deal of scientific progress over the past several months with our stem cell platform especially in characterization of the safety and efficacy in diabetic animal models," stated Jim Williams, Ph.D., chief operating officer of Opexa Therapeutics. "We are very proud to develop this novel autologous therapy and appreciate the guidance by the esteemed members of the Clinical Advisory Board who support the notion that autologous MDI transplantation has the potential to control diabetes."
The Opexa Therapeutics Clinical Advisory Board for MDI is comprised of:
F. Charles Brunicardi, M.D., F.A.C.S. - Chair
Dr. Brunicardi is the Chairman of the Michael E. DeBakey Department of Surgery at Baylor College of Medicine in Houston. Dr. Brunicardi's main area of research is the molecular engineering of islets for transplantation. He is a member of more than 36 professional societies, including the American Diabetes Association. A prolific writer, Dr. Brunicardi has co-authored 187 publications, 27 chapters, and 114 abstracts. He serves as Editor-in-Chief of Schwartz's Principles of Surgery textbook. Dr. Brunicardi also serves as a reviewer for such publications as Annals of Surgery, Diabetes, Pancreas, Journal of Surgical Research, Surgery, and American Journal of Physiology. He graduated with a B.A. in Chemistry from John Hopkins University in Baltimore, Maryland with honors then received his M.D. from Rutgers School of Medicine in Piscataway, New York.
John Goss, M.D.
Dr. John Goss is a Professor of Surgery and Chief of the Division of Abdominal Transplantation and Hepatobiliary Surgery in the Michael E. DeBakey Department of Surgery at Baylor College of Medicine in Houston and has served as the Director of Pancreatic Islet Transplantation, Director of the Baylor/Methodist Liver Transplant Center at Baylor College of Medicine and The Methodist Hospital, Director of Pediatric Liver Transplantation at Texas Children's Hospital, and Surgical Director of the Liver Center at Texas Children's Hospital. Dr. Goss is a well-respected transplant surgeon and has been conducting investigator-initiated investigational new drug pancreatic islet transplantation clinical studies since 2001. He has established himself as a brilliant technical surgeon and performed the first split liver adult and pediatric transplants in Houston. He received his M.D. from Creighton University in Omaha, Nebraska and completed a two year multi-organ transplant fellowship in the Division of Liver and Pancreas Transplantation at the University of California at the Los Angeles School of Medicine in Los Angeles, California. He was awarded The American Surgical Career Development Award, an American Liver Foundation Award, and a Juvenile Diabetes Research Foundation Award.
Dale Hamilton, M.D.
Dr. Hamilton joined the Baylor College of Medicine faculty in 1983 as a Clinical Instructor in the Department of Medicine, and he served as an Associate Professor from 2002 until 2006. Currently he is an attending physician and Service Chief for the Department of Diabetes, Obesity and Lipids in the academic Department of Medicine at The Methodist Hospital, Houston, TX. Dr. Hamilton began his medical training at the University of Washington where he graduated Magna Cum Laude with an undergraduate degree in cellular and molecular biology. He was nominated and became a member of Phi Beta Kappa honor society. He received his medical degree from St. Louis University in 1978, and he was inducted into Alpha Omega Alpha Honor Medical Society. Dr. Hamilton then moved to Houston, TX to complete his postgraduate training at Baylor College of Medicine Affiliated Hospitals where has remained. Dr. Hamilton was medical director of Diabetes Center of NW Houston from 1983 until 2002. During this time he has established himself as one of Houston's prominent endocrinology & metabolism doctors, and in 2002 he returned to Baylor College of Medicine full-time faculty. He has been awarded the Best or "Top" Doctor listing for the past 9 years. He is an active member of several professional societies and has served as a Houston Chapter Council Member for the of the American Diabetes Association since 2005 He has co-authored several publications, including the New England Journal of Medicine, American Journal of Neuroradiology, Transplantation, and Clinical Research in Cardiology. Dr. Hamilton's clinical and research interests include diabetes related heart disease and pancreatic islet cell transplantation. He worked with Dr. John Goss as a sub-investigator on the islet transplant program.
Saundra Hendricks M.S., A.P.R.N., BS-ADM
Ms. Hendricks earned her Bachelor of Science and Masters of Science in Nursing from Texas Woman's University. She was awarded the Scholarly Achievement Award and inducted into the Sigma Theta Tau, the international nurses honor society at TWU. She has been a Certified Diabetes Educator since 1987 and was awarded board certification in Advanced Diabetes Management in 2001. Ms. Hendricks has worked with Dr. Dale J. Hamilton since 1986. She developed and directed the Diabetes Center of NW Houston from 1986 to 2002. As an Instructor of Medicine from 2002 to 2006, mentored Endocrinology Fellows and physician residents in diabetes management and served as preceptor to nurse-practitioner students. Ms. Hendricks is currently director of the TMH nurse practitioner based diabetes management program. She teaches the diabetes content to the TWU nurse-practitioner students, lectures to professional nursing organizations, and provides consultations to the pharmaceutical industry regarding diabetes related issues.
Dr. F. Charles Brunicardi, said, "The Board that Opexa has assembled has a tremendous breadth and depth of knowledge and experience in the field and provides a cross-section of expertise in diabetes education and disease management, islet cell transplantation, clinical trial design, and cellular product development. This is vital to helping guide Opexa through the scientific and regulatory processes which the Company will face as it makes the transition from pre-clinical research to the clinical pipeline."
About Opexa
Opexa Therapeutics develops and commercializes cell therapies to treat autoimmune diseases such as multiple sclerosis, rheumatoid arthritis, and diabetes. The Company is focused on autologous cellular therapy applications of its proprietary T-cell and stem cell therapies. The Company's lead product, Tovaxin(TM), a T-cell therapy for multiple sclerosis is in Phase IIb trials. The Company holds the exclusive worldwide license for adult multipotent stem cells derived from mononuclear cells of peripheral blood. The technology allows large quantities of monocyte derived stem cells to be produced efficiently for use in autologous therapy, thus circumventing the threat of rejection. The Company is in preclinical development for diabetes mellitus. For more information, visit the Opexa Therapeutics website at www.opexatherapeutics.com.
Safe Harbor Statement
This press release contains "forward-looking statements," including statements about Opexa Therapeutics' growth and future operating results, discovery and development of products, strategic alliances and intellectual property, as well as other matters that are not historical facts or information. These forward-looking statements are based on management's current assumptions and expectations and involve risks, uncertainties and other important factors, specifically including those relating to Opexa Therapeutics' ability to obtain additional funding, develop its stem cell technologies, achieve its operational objectives, and obtain patent protection for its discoveries, that may cause Opexa Therapeutics' actual results to be materially different from any future results expressed or implied by such forward-looking statements. Opexa Therapeutics undertakes no obligation to update or revise any such forward-looking statements, whether as a result of new information, future events or otherwise.