Intezyne Technologies Announces Formation of Its Clinical Advisory Board

Tampa, FL – January 9, 2015 – Intezyne Technologies, a privately held drug development company dedicated to improving the treatment of cancer, announced it has formed the Intezyne Clinical Advisory Board to provide to management guidance and insight into the best clinical practices for treating patients with cancer, which will be integrated into the Company’s clinical study designs.  David Paul Kelsen, MD, will chair the committee that includes David B. Solit, MD, and Matthew H. Kulke, MD.  Amy S. Lee, PhD, the leading expert in GRP78 proteins, is serving as Advisor/Collaborator.

“We are exceptionally pleased to welcome Drs. Kelsen, Solit, Kulke, and Lee to Intezyne’s extended family. Advice from these experienced clinical and basic science investigators will help to guide the development of agents such as IT-139, our lead product candidate that targets GRP78, a cell-regulating protein, and the IVECT platform,” stated Habib Skaff, PhD, Chairman, President, and CEO of Intezyne. 

David Paul Kelsen, MD, is the Edward S. Gordon Chair in Medical Oncology at Memorial Sloan Kettering Cancer Center (MSK).  He is a board-certified medical oncologist with clinical and research interests in the field of gastrointestinal malignancies, neuroendocrine tumors, and cancers of unknown primary origin.  He is a physician on the Gastrointestinal Oncology Service, which he led as Chief from 1991 to 2011, and serves on MSK’s Research Council.  Dr. Kelsen’s research has been supported by grants from the National Cancer Institute, the American Cancer Society, and the Lustgarten Foundation.  Dr. Kelsen has served as a member of the Oncology Drug Advisory Committee of the U.S. Food and Drug Administration, the GI Committee of the Radiation Therapy Oncology Group, and the Investigational Drugs Steering Committee of the Cancer Therapy Evaluation Program of the National Cancer Institute.  He currently serves as co-Chair of the Clinical Trials subcommittee of the Lustgarten Foundation for Pancreatic Cancer Research.  Dr. Kelsen received his Doctor of Medicine from Hahnemann University School of Medicine (Philadelphia), conducted his residency at Temple University Hospital and his fellowship at MSK.

Matthew H. Kulke, MD, is Director, Program in Neuroendocrine and Carcinoid Tumors at the Dana-Farber Cancer Institute and Associate Profession of Medicine, Harvard Medical School.  Dr. Kulke has led numerous clinical and translational studies in patients with gastrointestinal malignancies and neuroendocrine tumors.  He has served as study chair for a national study of pancreatic cancer therapies performed by the Cancer and Leukemia group B and funded by the National Cancer Institute.  His current efforts have focused on clinical and translational research in carcinoid and pancreatic neuroendocrine tumors.  Dr. Kulke is the recipient of the George Canellos Award for Clinical Investigation and the Ruth Brufsky Award for Pancreatic Cancer Research.  He serves on the advisory board for the European Neuroendocrine Tumor Society, the executive committee of the North American Neuroendocrine Tumor Society, and is chair of the Neuroendocrine Tumor Task force for the National Cancer Institute.  Dr. Kulke received his Doctorate in Medicine from the University of California, San Francisco School of Medicine, completed an internship and residency in internal medicine at Brigham and Women's Hospital and his fellowship in medical oncology at Dana-Farber.  Dr. Kulke also has received a Master’s Degree in medical science from Harvard Medical School.

David B. Solit, MD, is the Geoffrey Beene Chair and Director of the Marie-Josée and Henry R. Kravis Center for Molecular Oncology at Memorial Sloan Kettering.  As a member of the Genitourinary Oncology Service, Dr. Solit specializes in treating cancers of the prostate, bladder, kidney, testis, and other related cancers.  He is very involved in clinical trials, particularly those of targeted drugs known as kinase inhibitors, which block pathways inside cancer cells that cause the cells to grow or spread.  Dr. Solit’s laboratory in the Human Oncology and Pathogenesis Program at MSKcompleted the first whole-genome analysis of a patient with bladder cancer who had a complete and durable response to a novel targeted drug that was effective in only a small minority of patients.  This analysis determined what was genetically unique about this patient’s tumor, and the group is testing the same drug in other patients whose tumors have a similar genetic profile.  As the Director of the Marie-Josée and Henry R. Kravis Center for Molecular Oncology (CMO), Dr. Solit leads a multidisciplinary team of clinicians, geneticists, bioinformaticians, and laboratory scientists.  The mission of the CMO is to integrate molecular and clinical information to develop therapies that are individualized to each patient’s cancer.  Dr. Solit received his Doctor of Medicine from the University of Pennsylvania School of Medicine, conducted his residency at Barnes Jewish Hospital/Washington University School of Medicine in St. Louis, and completed his fellowship at MSK.

Amy S. Lee, PhD, is a Programs in Biomedical and Biological Sciences (PIBBS) Mentor; Professor of Biochemistry and Molecular Biology at Keck School of Medicine, and Associate Director for Basic Research at the University Southern California (USC) Norris Comprehensive Cancer Center; and Professor of Biochemistry & Molecular Biology and the Judy and Larry Freeman Cosmetics Chair in Basic Science in Cancer Research.  Dr. Lee intimately understands the world of basic research, and her primary focus is on the regulation and function of two stress-induced proteins, GRP78/BiP and GRP94.  In April 2014, she published the most extensive paper written on the topic (Cancer Res April 15, 2007 67; 3496).  Recruited to USC in 1979 as an Assistant Professor of biochemistry from the California Institute of Technology, she has devoted 25 years to two major areas of research.  The first is towards understanding the molecular mechanisms that mammalian cells use to manage physiological and environmental stress - such as the stress of cancer.  The second involves investigating how and why cells go through the cell cycle.  As Associate Director for Basic Research, Dr. Lee has direct responsibility for the organization and direction of the Molecular Genetics, Epigenetics and Regulation, and Tumor Microenvironment Programs.  She has received an American Cancer Society Junior Faculty Research Award and Faculty Research Award, the USC University Scholar Award, and the National Cancer Institute's MERIT Award.  Dr. Lee earned her doctorate in Biology and Biophysics in 1975 from Caltech, with a major emphasis on fundamental knowledge of DNA, protein and cells.

About Intezyne Technologies

Intezyne is dedicated to treating cancer better. The Company’s lead compound, IT-139,  targets GRP78, a protein widely recognized for its role in cancer cell survival, which recently has begun receiving attention as a potential therapeutic target for oncology drug development.  Intezyne's breakthrough nanotechnology platform, the IVECT(TM) Method, was invented by the Company's co-founders, Habib Skaff, PhD, and Kevin Sill, PhD, synthetic chemists specializing in nanotechnology and polymer chemistry.  IVECT-derived nanoparticles can be generated around a broad array of drugs, from small molecules to peptides/proteins to nucleic acids, making the platform highly versatile in its applicability and scope.  These nanoparticles can be enhanced further by adding a desired targeting ligand/receptor to the surface of the nanoparticle.  Preclinical work conducted by Intezyne has shown the IVECT-derived anti-cancer nanoparticles preferentially accumulate in tumor cells, thereby sparing the normal healthy cells, and have shown positive preclinical efficacy and safety profiles in multiple cancer models versus best-in-class chemotherapeutic agents.  Intezyne currently has three IVECT-based product candidates in development and has conducted numerous product development projects for global pharmaceutical companies.  For more information, please visit the Company's website at www.intezyne.com.